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Conway: HM well positioned for ‘system transformation’
Patrick Conway, MD, MSc, MHM, may have had a lot of job titles recently, but his work address hasn’t changed in 6 years.
Dr. Conway, deputy administrator for innovation and quality for the Centers for Medicare & Medicaid Services and director of its Center for Medicare and Medicaid Innovation, has been at the intersection of policy and practice in Washington, since joining CMS in 2011. The still-practicing hospitalist was acting CMS administrator for several months earlier this year, holding the top post while President Donald Trump’s nominee to lead the agency, Seema Verma, awaited U.S. Senate confirmation. His title before that was principal deputy administrator and CMS chief medical officer.
Dr. Conway said he believes that at a “macro legislation” level, Washington is committed to health care reform that improves patient care and incentivizes physicians to join alternative payment models (APMs). He said hospitalists should be encouraged by how well the field has already adapted to the proliferation of accountable-care organizations, value-based purchasing, and the Medicare Access and CHIP Reauthorization Act of 2015, or MACRA. He said that as innovations lead to better patient care and more coordinated care, that’s good for hospitalists, patients, and the hospitals that bring them together.
“I want to leave people with the idea that value-based payment innovation and delivery system reform will continue to be critical aspects of improving our health system,” he said. “I also want hospitalists to continue to stay engaged in these new payment models and help lead them and provide better patient care as part of them.”
Dr. Conway said that focusing on innovations is essential to hospitalists to ensure the specialty remains at the forefront of improved patient care, decreased readmissions, decreased infections and other quality improvements. He notes that by still practicing on an academic medical service with faculty, residents and medical students, he’s encouraged and excited that “people get it.”
“Every doctor wants better care for their patients,” Dr. Conway said. “The reality of … new payment systems and new fields of innovation we’re entering into is it unleashes hospitalists and aligns incentives with what they want for their patients.”
Take bundled payments around episodic care. With innovations in payment models, hospitalists are increasingly being paid for how good their care is, not how much care there is.
“That’s exciting,” Dr. Conway said. “Very different than 10 years ago where you had a lot of groups where it was about how much volume can we churn through. Now I think hospitals and HM groups [realize] value is going to continue to increasingly be based on the quality of care and the efficiency of care delivery.”
Patrick Conway, MD, MSc, MHM, may have had a lot of job titles recently, but his work address hasn’t changed in 6 years.
Dr. Conway, deputy administrator for innovation and quality for the Centers for Medicare & Medicaid Services and director of its Center for Medicare and Medicaid Innovation, has been at the intersection of policy and practice in Washington, since joining CMS in 2011. The still-practicing hospitalist was acting CMS administrator for several months earlier this year, holding the top post while President Donald Trump’s nominee to lead the agency, Seema Verma, awaited U.S. Senate confirmation. His title before that was principal deputy administrator and CMS chief medical officer.
Dr. Conway said he believes that at a “macro legislation” level, Washington is committed to health care reform that improves patient care and incentivizes physicians to join alternative payment models (APMs). He said hospitalists should be encouraged by how well the field has already adapted to the proliferation of accountable-care organizations, value-based purchasing, and the Medicare Access and CHIP Reauthorization Act of 2015, or MACRA. He said that as innovations lead to better patient care and more coordinated care, that’s good for hospitalists, patients, and the hospitals that bring them together.
“I want to leave people with the idea that value-based payment innovation and delivery system reform will continue to be critical aspects of improving our health system,” he said. “I also want hospitalists to continue to stay engaged in these new payment models and help lead them and provide better patient care as part of them.”
Dr. Conway said that focusing on innovations is essential to hospitalists to ensure the specialty remains at the forefront of improved patient care, decreased readmissions, decreased infections and other quality improvements. He notes that by still practicing on an academic medical service with faculty, residents and medical students, he’s encouraged and excited that “people get it.”
“Every doctor wants better care for their patients,” Dr. Conway said. “The reality of … new payment systems and new fields of innovation we’re entering into is it unleashes hospitalists and aligns incentives with what they want for their patients.”
Take bundled payments around episodic care. With innovations in payment models, hospitalists are increasingly being paid for how good their care is, not how much care there is.
“That’s exciting,” Dr. Conway said. “Very different than 10 years ago where you had a lot of groups where it was about how much volume can we churn through. Now I think hospitals and HM groups [realize] value is going to continue to increasingly be based on the quality of care and the efficiency of care delivery.”
Patrick Conway, MD, MSc, MHM, may have had a lot of job titles recently, but his work address hasn’t changed in 6 years.
Dr. Conway, deputy administrator for innovation and quality for the Centers for Medicare & Medicaid Services and director of its Center for Medicare and Medicaid Innovation, has been at the intersection of policy and practice in Washington, since joining CMS in 2011. The still-practicing hospitalist was acting CMS administrator for several months earlier this year, holding the top post while President Donald Trump’s nominee to lead the agency, Seema Verma, awaited U.S. Senate confirmation. His title before that was principal deputy administrator and CMS chief medical officer.
Dr. Conway said he believes that at a “macro legislation” level, Washington is committed to health care reform that improves patient care and incentivizes physicians to join alternative payment models (APMs). He said hospitalists should be encouraged by how well the field has already adapted to the proliferation of accountable-care organizations, value-based purchasing, and the Medicare Access and CHIP Reauthorization Act of 2015, or MACRA. He said that as innovations lead to better patient care and more coordinated care, that’s good for hospitalists, patients, and the hospitals that bring them together.
“I want to leave people with the idea that value-based payment innovation and delivery system reform will continue to be critical aspects of improving our health system,” he said. “I also want hospitalists to continue to stay engaged in these new payment models and help lead them and provide better patient care as part of them.”
Dr. Conway said that focusing on innovations is essential to hospitalists to ensure the specialty remains at the forefront of improved patient care, decreased readmissions, decreased infections and other quality improvements. He notes that by still practicing on an academic medical service with faculty, residents and medical students, he’s encouraged and excited that “people get it.”
“Every doctor wants better care for their patients,” Dr. Conway said. “The reality of … new payment systems and new fields of innovation we’re entering into is it unleashes hospitalists and aligns incentives with what they want for their patients.”
Take bundled payments around episodic care. With innovations in payment models, hospitalists are increasingly being paid for how good their care is, not how much care there is.
“That’s exciting,” Dr. Conway said. “Very different than 10 years ago where you had a lot of groups where it was about how much volume can we churn through. Now I think hospitals and HM groups [realize] value is going to continue to increasingly be based on the quality of care and the efficiency of care delivery.”
High-value care abstracts in spotlight
If the annual meeting of the Society of Hospital Medicine could be boiled down to a single goal, it might be to give hospitalists the information they need to be the best doctors they can be.
It shouldn’t come as a surprise, then, that research performed by hospitalists on high-value care (HVC) will be featured in an abstract session at this year’s conference.
The “Best of HVC Abstract Submissions” session, scheduled for Tuesday, May 2, 3:05–3:45 p.m., will be part of a day-long track devoted entirely to HVC, a new feature at this year’s annual meeting.
“The panel will give them feedback and ask questions and sort of engage in conversation about it,” Dr. Feldman said. He thinks that featuring these abstracts in a high-profile setting is a good way for hospitalists to learn from one another. “There are so many hospitalists interested in this topic right now and people working in this area and coming up with quality improvement projects around high-value care. It’s nice to know what other folks are doing.”
Dr. Feldman hopes that, if hospitalists find out what is happening at other centers, it will spur even more quality projects.
“We don’t often have the opportunity to share the work that we’ve done and to motivate each other,” he said. “When you hear about the great work that other people are doing, it is invigorating; it’s exciting; it gets you jazzed up about doing the work in your own institution. A lot of this isn’t incredibly sophisticated. It is stuff that can be relatively easily disseminated from one institution to another without having a ton of support. To be able to see the type of work that people do is thrilling for the hospitalists who attend.”
“With the growing recognition of the costs and harms from medical overuse, high-value care has become a national imperative,” he said. “Hospitalists are natural leaders for high-value care, much like we have been for patient safety and quality improvement. Hospitalists have already led the way on developing programs that target areas of overuse in hospitals. Our ‘Best of HVC’ session will highlight many of these promising examples. There will be plenty of opportunities to learn from innovators and take back the best ideas to our own hospitals.”
Organizers said that the HVC track “will guide attendees on how to avoid diagnostic and therapeutic overuse and how to move toward the right care for every hospital medicine patient.” Other sessions in the track will cover “things we do for no reason,” how to use imaging wisely, and tips on overcoming cultures fraught with overuse.
Dr. Feldman said the track is intended to meet the demand of meeting attendees.
“There are lots of hospitalists who are engaging in this type of work in their institutions and systems,” he said. “So, it’s just timely. People are engaged in it and they’re excited about it, so it makes sense that adding a track right now would fulfill the needs of many of the hospitalists who are going to be attending.”
Best of HVC Abstract Submissions
Tuesday, May 2, 3:05–3:45 p.m.
If the annual meeting of the Society of Hospital Medicine could be boiled down to a single goal, it might be to give hospitalists the information they need to be the best doctors they can be.
It shouldn’t come as a surprise, then, that research performed by hospitalists on high-value care (HVC) will be featured in an abstract session at this year’s conference.
The “Best of HVC Abstract Submissions” session, scheduled for Tuesday, May 2, 3:05–3:45 p.m., will be part of a day-long track devoted entirely to HVC, a new feature at this year’s annual meeting.
“The panel will give them feedback and ask questions and sort of engage in conversation about it,” Dr. Feldman said. He thinks that featuring these abstracts in a high-profile setting is a good way for hospitalists to learn from one another. “There are so many hospitalists interested in this topic right now and people working in this area and coming up with quality improvement projects around high-value care. It’s nice to know what other folks are doing.”
Dr. Feldman hopes that, if hospitalists find out what is happening at other centers, it will spur even more quality projects.
“We don’t often have the opportunity to share the work that we’ve done and to motivate each other,” he said. “When you hear about the great work that other people are doing, it is invigorating; it’s exciting; it gets you jazzed up about doing the work in your own institution. A lot of this isn’t incredibly sophisticated. It is stuff that can be relatively easily disseminated from one institution to another without having a ton of support. To be able to see the type of work that people do is thrilling for the hospitalists who attend.”
“With the growing recognition of the costs and harms from medical overuse, high-value care has become a national imperative,” he said. “Hospitalists are natural leaders for high-value care, much like we have been for patient safety and quality improvement. Hospitalists have already led the way on developing programs that target areas of overuse in hospitals. Our ‘Best of HVC’ session will highlight many of these promising examples. There will be plenty of opportunities to learn from innovators and take back the best ideas to our own hospitals.”
Organizers said that the HVC track “will guide attendees on how to avoid diagnostic and therapeutic overuse and how to move toward the right care for every hospital medicine patient.” Other sessions in the track will cover “things we do for no reason,” how to use imaging wisely, and tips on overcoming cultures fraught with overuse.
Dr. Feldman said the track is intended to meet the demand of meeting attendees.
“There are lots of hospitalists who are engaging in this type of work in their institutions and systems,” he said. “So, it’s just timely. People are engaged in it and they’re excited about it, so it makes sense that adding a track right now would fulfill the needs of many of the hospitalists who are going to be attending.”
Best of HVC Abstract Submissions
Tuesday, May 2, 3:05–3:45 p.m.
If the annual meeting of the Society of Hospital Medicine could be boiled down to a single goal, it might be to give hospitalists the information they need to be the best doctors they can be.
It shouldn’t come as a surprise, then, that research performed by hospitalists on high-value care (HVC) will be featured in an abstract session at this year’s conference.
The “Best of HVC Abstract Submissions” session, scheduled for Tuesday, May 2, 3:05–3:45 p.m., will be part of a day-long track devoted entirely to HVC, a new feature at this year’s annual meeting.
“The panel will give them feedback and ask questions and sort of engage in conversation about it,” Dr. Feldman said. He thinks that featuring these abstracts in a high-profile setting is a good way for hospitalists to learn from one another. “There are so many hospitalists interested in this topic right now and people working in this area and coming up with quality improvement projects around high-value care. It’s nice to know what other folks are doing.”
Dr. Feldman hopes that, if hospitalists find out what is happening at other centers, it will spur even more quality projects.
“We don’t often have the opportunity to share the work that we’ve done and to motivate each other,” he said. “When you hear about the great work that other people are doing, it is invigorating; it’s exciting; it gets you jazzed up about doing the work in your own institution. A lot of this isn’t incredibly sophisticated. It is stuff that can be relatively easily disseminated from one institution to another without having a ton of support. To be able to see the type of work that people do is thrilling for the hospitalists who attend.”
“With the growing recognition of the costs and harms from medical overuse, high-value care has become a national imperative,” he said. “Hospitalists are natural leaders for high-value care, much like we have been for patient safety and quality improvement. Hospitalists have already led the way on developing programs that target areas of overuse in hospitals. Our ‘Best of HVC’ session will highlight many of these promising examples. There will be plenty of opportunities to learn from innovators and take back the best ideas to our own hospitals.”
Organizers said that the HVC track “will guide attendees on how to avoid diagnostic and therapeutic overuse and how to move toward the right care for every hospital medicine patient.” Other sessions in the track will cover “things we do for no reason,” how to use imaging wisely, and tips on overcoming cultures fraught with overuse.
Dr. Feldman said the track is intended to meet the demand of meeting attendees.
“There are lots of hospitalists who are engaging in this type of work in their institutions and systems,” he said. “So, it’s just timely. People are engaged in it and they’re excited about it, so it makes sense that adding a track right now would fulfill the needs of many of the hospitalists who are going to be attending.”
Best of HVC Abstract Submissions
Tuesday, May 2, 3:05–3:45 p.m.
Speed-mentoring event targets junior hospitalists
When senior physicians and researchers – including hospitalists – talk about their careers, it seems they never fail to mention the mentors who helped shape their professional lives. Mentoring matters – a lot.
Junior hospitalists have a chance to receive mentoring in an area of their choice at HM17.
“This is their opportunity to get ‘rapid-fire’ advice from senior hospitalists from a variety of perspectives,” said event organizer Joanna Bonsall, MD, PhD, SFHM, assistant professor of medicine at Emory University, Atlanta.
The advisers are chosen because of their commitment to supporting career development and because of their reputation and expertise. Many of the speed mentors are returning to the event for the fourth time. It has been held at the SHM annual meeting since 2013.
“This event doesn’t replace traditional mentorship but does give junior hospitalists an opportunity to discuss an aspect of their career with multiple senior hospitalists from across the country,” Dr. Bonsall said.
When senior physicians and researchers – including hospitalists – talk about their careers, it seems they never fail to mention the mentors who helped shape their professional lives. Mentoring matters – a lot.
Junior hospitalists have a chance to receive mentoring in an area of their choice at HM17.
“This is their opportunity to get ‘rapid-fire’ advice from senior hospitalists from a variety of perspectives,” said event organizer Joanna Bonsall, MD, PhD, SFHM, assistant professor of medicine at Emory University, Atlanta.
The advisers are chosen because of their commitment to supporting career development and because of their reputation and expertise. Many of the speed mentors are returning to the event for the fourth time. It has been held at the SHM annual meeting since 2013.
“This event doesn’t replace traditional mentorship but does give junior hospitalists an opportunity to discuss an aspect of their career with multiple senior hospitalists from across the country,” Dr. Bonsall said.
When senior physicians and researchers – including hospitalists – talk about their careers, it seems they never fail to mention the mentors who helped shape their professional lives. Mentoring matters – a lot.
Junior hospitalists have a chance to receive mentoring in an area of their choice at HM17.
“This is their opportunity to get ‘rapid-fire’ advice from senior hospitalists from a variety of perspectives,” said event organizer Joanna Bonsall, MD, PhD, SFHM, assistant professor of medicine at Emory University, Atlanta.
The advisers are chosen because of their commitment to supporting career development and because of their reputation and expertise. Many of the speed mentors are returning to the event for the fourth time. It has been held at the SHM annual meeting since 2013.
“This event doesn’t replace traditional mentorship but does give junior hospitalists an opportunity to discuss an aspect of their career with multiple senior hospitalists from across the country,” Dr. Bonsall said.
Advances in Hematology and Oncology (May 2017)
Table of Contents
- Thirteen Years and Still Growing: An AVAHO History
- Criteria for Use Updates for Enzalutamide, Daratumumab, Elotuzumab, Carfilzomib, and Ixazomib
- Lung Cancer Screening: Translating Research Into Practice
- Open Clinical Trials for Patients With Colorectal Cancer
- Treatment and Management of Patients With Prostate Cancer
- Cancer Care Collaborative Approach to Optimize Clinical Care
- Patient Knowledge of and Barriers to Breast, Colon, and Cervical Cancer Screenings: A Cross-Sectional Survey of TRICARE Beneficiaries
- Novel Neuroendocrine Tumor in Multiple Endocrine Neoplasia Type 1
Table of Contents
- Thirteen Years and Still Growing: An AVAHO History
- Criteria for Use Updates for Enzalutamide, Daratumumab, Elotuzumab, Carfilzomib, and Ixazomib
- Lung Cancer Screening: Translating Research Into Practice
- Open Clinical Trials for Patients With Colorectal Cancer
- Treatment and Management of Patients With Prostate Cancer
- Cancer Care Collaborative Approach to Optimize Clinical Care
- Patient Knowledge of and Barriers to Breast, Colon, and Cervical Cancer Screenings: A Cross-Sectional Survey of TRICARE Beneficiaries
- Novel Neuroendocrine Tumor in Multiple Endocrine Neoplasia Type 1
Table of Contents
- Thirteen Years and Still Growing: An AVAHO History
- Criteria for Use Updates for Enzalutamide, Daratumumab, Elotuzumab, Carfilzomib, and Ixazomib
- Lung Cancer Screening: Translating Research Into Practice
- Open Clinical Trials for Patients With Colorectal Cancer
- Treatment and Management of Patients With Prostate Cancer
- Cancer Care Collaborative Approach to Optimize Clinical Care
- Patient Knowledge of and Barriers to Breast, Colon, and Cervical Cancer Screenings: A Cross-Sectional Survey of TRICARE Beneficiaries
- Novel Neuroendocrine Tumor in Multiple Endocrine Neoplasia Type 1
Chronic Lymphocytic Leukemia in the Real World
A diagnosis of chronic lymphocytic leukemia (CLL) usually occurs in people aged ≥ 72 years. But most clinical trials do not reflect that reality; thus, treatments and prognoses are based on younger patients’ experiences. Researchers from University of Pennsylvania, Emory University in Georgia, NorthShore University HealthSystem in Illinois, New York-Presbyterian Hospital/Columbia University Medical Center, Thomas Jefferson University in Pennsylvania, and Dana-Farber Cancer Institute in Massachusetts, conducted the largest comprehensive prospective evaluation of this patient population published to date to their knowledge to examine treatment patterns, outcomes, and disease-related mortality in CLL patients aged ≥ 75 years in a real-world setting.
The researchers analyzed data from patients in the Connect® CLL registry, a prospective observational cohort study that took place between 2010 and 2014 at 199 U.S. sites. Of 1,494 patients enrolled in the registry, 259 patients aged ≥ 75 years were enrolled within 2 months of starting first- line of therapy (LOT1), and 196 were enrolled in a subsequent line of therapy (LOT ≥ 2). The patients were almost entirely enrolled prior to the introduction of novel B-cell receptor-targeted therapies. The researchers say they aimed to establish a benchmark for outcomes in elderly patients with CLL who were treated before those therapies to help properly position newer agents in the treatment paradigm.
They found that elderly patients with CLL were more likely than were younger patients to receive rituximab monotherapy. In LOT ≥ 2 they were significantly less likely to receive bendamustine/rituximab. Only 6.9% of patients aged > 75 years received fludarabine/cyclophosphamide/rituximab, vs 33.7% of patients aged < 75 years. Interestingly, the researchers add, older patients were significantly more likely than were younger patients to receive chemotherapy alone without anti-CD20 antibody therapy.
Serious adverse events were more common in the elderly patients. Pneumonia was more common in elderly patients in LOT1; in LOT ≥ 2, rates of pneumonia were similar in both groups. In the follow-up with a median of 32.6 months, 433 of the 1,494 patients had died. Only 5% of patients aged < 75 years in LOT1 died of CLL, compared with 13% of elderly patients. Time to death from CLL or infection was also significantly shorter in patients aged > 75 years, compared with patients aged < 75 years. When stratified by risk, mortality due to CLL or infection was 10.3% in the lower risk group compared with 30.6% in the higher risk group.
The researchers identified 3 prognostic indicators: < 3 months from diagnosis to first treatment, enrollment therapy other than bendamustine/rituximab, and anemia. The researchers say the higher risk of CLL- or infection-related death has not, to their knowledge, been reported previously. This finding, they say, “highlights the urgent need for therapies tailored to this population.” Current therapies and strategies, they note, “appear suboptimal.”
Source:
Nabhan C, Mato A, Flowers CR, et al. BMC Cancer. 2017;17(1):198.
doi: 10.1186/s12885-017-3176-x.
A diagnosis of chronic lymphocytic leukemia (CLL) usually occurs in people aged ≥ 72 years. But most clinical trials do not reflect that reality; thus, treatments and prognoses are based on younger patients’ experiences. Researchers from University of Pennsylvania, Emory University in Georgia, NorthShore University HealthSystem in Illinois, New York-Presbyterian Hospital/Columbia University Medical Center, Thomas Jefferson University in Pennsylvania, and Dana-Farber Cancer Institute in Massachusetts, conducted the largest comprehensive prospective evaluation of this patient population published to date to their knowledge to examine treatment patterns, outcomes, and disease-related mortality in CLL patients aged ≥ 75 years in a real-world setting.
The researchers analyzed data from patients in the Connect® CLL registry, a prospective observational cohort study that took place between 2010 and 2014 at 199 U.S. sites. Of 1,494 patients enrolled in the registry, 259 patients aged ≥ 75 years were enrolled within 2 months of starting first- line of therapy (LOT1), and 196 were enrolled in a subsequent line of therapy (LOT ≥ 2). The patients were almost entirely enrolled prior to the introduction of novel B-cell receptor-targeted therapies. The researchers say they aimed to establish a benchmark for outcomes in elderly patients with CLL who were treated before those therapies to help properly position newer agents in the treatment paradigm.
They found that elderly patients with CLL were more likely than were younger patients to receive rituximab monotherapy. In LOT ≥ 2 they were significantly less likely to receive bendamustine/rituximab. Only 6.9% of patients aged > 75 years received fludarabine/cyclophosphamide/rituximab, vs 33.7% of patients aged < 75 years. Interestingly, the researchers add, older patients were significantly more likely than were younger patients to receive chemotherapy alone without anti-CD20 antibody therapy.
Serious adverse events were more common in the elderly patients. Pneumonia was more common in elderly patients in LOT1; in LOT ≥ 2, rates of pneumonia were similar in both groups. In the follow-up with a median of 32.6 months, 433 of the 1,494 patients had died. Only 5% of patients aged < 75 years in LOT1 died of CLL, compared with 13% of elderly patients. Time to death from CLL or infection was also significantly shorter in patients aged > 75 years, compared with patients aged < 75 years. When stratified by risk, mortality due to CLL or infection was 10.3% in the lower risk group compared with 30.6% in the higher risk group.
The researchers identified 3 prognostic indicators: < 3 months from diagnosis to first treatment, enrollment therapy other than bendamustine/rituximab, and anemia. The researchers say the higher risk of CLL- or infection-related death has not, to their knowledge, been reported previously. This finding, they say, “highlights the urgent need for therapies tailored to this population.” Current therapies and strategies, they note, “appear suboptimal.”
Source:
Nabhan C, Mato A, Flowers CR, et al. BMC Cancer. 2017;17(1):198.
doi: 10.1186/s12885-017-3176-x.
A diagnosis of chronic lymphocytic leukemia (CLL) usually occurs in people aged ≥ 72 years. But most clinical trials do not reflect that reality; thus, treatments and prognoses are based on younger patients’ experiences. Researchers from University of Pennsylvania, Emory University in Georgia, NorthShore University HealthSystem in Illinois, New York-Presbyterian Hospital/Columbia University Medical Center, Thomas Jefferson University in Pennsylvania, and Dana-Farber Cancer Institute in Massachusetts, conducted the largest comprehensive prospective evaluation of this patient population published to date to their knowledge to examine treatment patterns, outcomes, and disease-related mortality in CLL patients aged ≥ 75 years in a real-world setting.
The researchers analyzed data from patients in the Connect® CLL registry, a prospective observational cohort study that took place between 2010 and 2014 at 199 U.S. sites. Of 1,494 patients enrolled in the registry, 259 patients aged ≥ 75 years were enrolled within 2 months of starting first- line of therapy (LOT1), and 196 were enrolled in a subsequent line of therapy (LOT ≥ 2). The patients were almost entirely enrolled prior to the introduction of novel B-cell receptor-targeted therapies. The researchers say they aimed to establish a benchmark for outcomes in elderly patients with CLL who were treated before those therapies to help properly position newer agents in the treatment paradigm.
They found that elderly patients with CLL were more likely than were younger patients to receive rituximab monotherapy. In LOT ≥ 2 they were significantly less likely to receive bendamustine/rituximab. Only 6.9% of patients aged > 75 years received fludarabine/cyclophosphamide/rituximab, vs 33.7% of patients aged < 75 years. Interestingly, the researchers add, older patients were significantly more likely than were younger patients to receive chemotherapy alone without anti-CD20 antibody therapy.
Serious adverse events were more common in the elderly patients. Pneumonia was more common in elderly patients in LOT1; in LOT ≥ 2, rates of pneumonia were similar in both groups. In the follow-up with a median of 32.6 months, 433 of the 1,494 patients had died. Only 5% of patients aged < 75 years in LOT1 died of CLL, compared with 13% of elderly patients. Time to death from CLL or infection was also significantly shorter in patients aged > 75 years, compared with patients aged < 75 years. When stratified by risk, mortality due to CLL or infection was 10.3% in the lower risk group compared with 30.6% in the higher risk group.
The researchers identified 3 prognostic indicators: < 3 months from diagnosis to first treatment, enrollment therapy other than bendamustine/rituximab, and anemia. The researchers say the higher risk of CLL- or infection-related death has not, to their knowledge, been reported previously. This finding, they say, “highlights the urgent need for therapies tailored to this population.” Current therapies and strategies, they note, “appear suboptimal.”
Source:
Nabhan C, Mato A, Flowers CR, et al. BMC Cancer. 2017;17(1):198.
doi: 10.1186/s12885-017-3176-x.
FDA approves first ready-to-use oral solution of methotrexate
The US Food and Drug Administration (FDA) has approved a ready-to-use oral solution of methotrexate (Xatmep) for use in certain pediatric patients.
The drug is approved as part of a multi-phase, combination chemotherapy maintenance regimen to treat pediatric patients with acute lymphoblastic leukemia.
Xatmep is also approved for use in pediatric patients with active polyarticular juvenile idiopathic arthritis who have had an insufficient response to, or cannot tolerate, an adequate trial of first-line therapy, including full-dose non-steroidal anti-inflammatory agents.
Xatmep is the first ready-to-use oral solution of methotrexate to be approved by the FDA.
There was previously no such formulation of the drug approved for use in pediatric patients requiring body surface area dosing (mg/m2), patients who have difficulty swallowing or cannot consume tablets, or those with needle-phobia.
Xatmep (methotrexate) Oral Solution, 2.5 mg/mL, requires no preparation. It eliminates the need for needles, crushing or splitting tablets, or for compounding tablets into a liquid formulation.
Xatmep requires refrigeration but may be stored at room temperature for 60 days after dispensing.
For more on Xatmep, see the prescribing information, which includes a boxed warning detailing the risk of severe toxic reactions, including embryo-fetal toxicity.
Xatmep is available through pharmacies and a qualified mail-order service. For information on how to obtain the drug, call 1-855-379-0382.
Xatmep is a product of Silvergate Pharmaceuticals, Inc. 
The US Food and Drug Administration (FDA) has approved a ready-to-use oral solution of methotrexate (Xatmep) for use in certain pediatric patients.
The drug is approved as part of a multi-phase, combination chemotherapy maintenance regimen to treat pediatric patients with acute lymphoblastic leukemia.
Xatmep is also approved for use in pediatric patients with active polyarticular juvenile idiopathic arthritis who have had an insufficient response to, or cannot tolerate, an adequate trial of first-line therapy, including full-dose non-steroidal anti-inflammatory agents.
Xatmep is the first ready-to-use oral solution of methotrexate to be approved by the FDA.
There was previously no such formulation of the drug approved for use in pediatric patients requiring body surface area dosing (mg/m2), patients who have difficulty swallowing or cannot consume tablets, or those with needle-phobia.
Xatmep (methotrexate) Oral Solution, 2.5 mg/mL, requires no preparation. It eliminates the need for needles, crushing or splitting tablets, or for compounding tablets into a liquid formulation.
Xatmep requires refrigeration but may be stored at room temperature for 60 days after dispensing.
For more on Xatmep, see the prescribing information, which includes a boxed warning detailing the risk of severe toxic reactions, including embryo-fetal toxicity.
Xatmep is available through pharmacies and a qualified mail-order service. For information on how to obtain the drug, call 1-855-379-0382.
Xatmep is a product of Silvergate Pharmaceuticals, Inc.
The US Food and Drug Administration (FDA) has approved a ready-to-use oral solution of methotrexate (Xatmep) for use in certain pediatric patients.
The drug is approved as part of a multi-phase, combination chemotherapy maintenance regimen to treat pediatric patients with acute lymphoblastic leukemia.
Xatmep is also approved for use in pediatric patients with active polyarticular juvenile idiopathic arthritis who have had an insufficient response to, or cannot tolerate, an adequate trial of first-line therapy, including full-dose non-steroidal anti-inflammatory agents.
Xatmep is the first ready-to-use oral solution of methotrexate to be approved by the FDA.
There was previously no such formulation of the drug approved for use in pediatric patients requiring body surface area dosing (mg/m2), patients who have difficulty swallowing or cannot consume tablets, or those with needle-phobia.
Xatmep (methotrexate) Oral Solution, 2.5 mg/mL, requires no preparation. It eliminates the need for needles, crushing or splitting tablets, or for compounding tablets into a liquid formulation.
Xatmep requires refrigeration but may be stored at room temperature for 60 days after dispensing.
For more on Xatmep, see the prescribing information, which includes a boxed warning detailing the risk of severe toxic reactions, including embryo-fetal toxicity.
Xatmep is available through pharmacies and a qualified mail-order service. For information on how to obtain the drug, call 1-855-379-0382.
Xatmep is a product of Silvergate Pharmaceuticals, Inc.
Blood groups associated with risk of heart attack
PARIS—Having a blood type other than O is associated with a higher risk of heart attack, according to a meta-analysis.
“It has been suggested that people with non-O blood groups (A, B, AB) are at higher risk for heart attacks and overall cardiovascular mortality, but this suggestion comes from case-control studies, which have a low level of evidence,” said Tessa Kole, a student at the University Medical Centre Groningen in the Netherlands.
Therefore, Kole and her fellow investigators conducted a meta-analysis of prospective studies reporting on blood groups and incident cardiovascular events.
The team presented their findings at Heart Failure 2017 and the 4th World Congress on Acute Heart Failure (abstract 697).
The study included 1,362,569 subjects from 11 prospective cohorts, described in 9 articles. There were a total of 23,154 cardiovascular events.
The investigators analyzed the association between blood group and all coronary events, combined cardiovascular events, and fatal coronary events.
The analysis of all coronary events included 771,113 subjects with a non-O blood group and 519,743 with an O blood group, of whom 11,437 (1.5%) and 7220 (1.4%), respectively, suffered a coronary event.
The odds ratio (OR) for all coronary events was significantly higher in subjects with a non-O blood group, at 1.09 (95% confidence interval [CI], 1.06-1.13, P<0.00001).
The analysis of combined cardiovascular events included 708,276 subjects with a non-O blood group and 476,868 with an O blood group, of whom 17,449 (2.5%) and 10,916 (2.3%), respectively, had an event.
The OR for combined cardiovascular events was significantly higher in subjects with non-O blood groups, at 1.09 (95% CI, 1.06-1.11, P=0.006).
The analysis of fatal coronary events did not show a significant difference between people with O and non-O blood groups. The OR was 1.00 (95% CI, 0.85-1.18, P=0.98).
“We demonstrate that having a non-O blood group is associated with a 9% increased risk of coronary events and a 9% increased risk of cardiovascular events, especially myocardial infarction,” Kole said.
“More research is needed to identify the cause of the apparent increased cardiovascular risk in people with a non-O blood group. Obtaining more information about risk in each non-O blood group (A, B, and AB) might provide further explanations of the causes.”
“In future, blood group should be considered in risk assessment for cardiovascular prevention, together with cholesterol, age, sex, and systolic blood pressure. It could be that people with an A blood group should have a lower treatment threshold for dyslipidemia or hypertension, for example. We need further studies to validate if the excess cardiovascular risk in non-O blood group carriers may be amenable to treatment.”
PARIS—Having a blood type other than O is associated with a higher risk of heart attack, according to a meta-analysis.
“It has been suggested that people with non-O blood groups (A, B, AB) are at higher risk for heart attacks and overall cardiovascular mortality, but this suggestion comes from case-control studies, which have a low level of evidence,” said Tessa Kole, a student at the University Medical Centre Groningen in the Netherlands.
Therefore, Kole and her fellow investigators conducted a meta-analysis of prospective studies reporting on blood groups and incident cardiovascular events.
The team presented their findings at Heart Failure 2017 and the 4th World Congress on Acute Heart Failure (abstract 697).
The study included 1,362,569 subjects from 11 prospective cohorts, described in 9 articles. There were a total of 23,154 cardiovascular events.
The investigators analyzed the association between blood group and all coronary events, combined cardiovascular events, and fatal coronary events.
The analysis of all coronary events included 771,113 subjects with a non-O blood group and 519,743 with an O blood group, of whom 11,437 (1.5%) and 7220 (1.4%), respectively, suffered a coronary event.
The odds ratio (OR) for all coronary events was significantly higher in subjects with a non-O blood group, at 1.09 (95% confidence interval [CI], 1.06-1.13, P<0.00001).
The analysis of combined cardiovascular events included 708,276 subjects with a non-O blood group and 476,868 with an O blood group, of whom 17,449 (2.5%) and 10,916 (2.3%), respectively, had an event.
The OR for combined cardiovascular events was significantly higher in subjects with non-O blood groups, at 1.09 (95% CI, 1.06-1.11, P=0.006).
The analysis of fatal coronary events did not show a significant difference between people with O and non-O blood groups. The OR was 1.00 (95% CI, 0.85-1.18, P=0.98).
“We demonstrate that having a non-O blood group is associated with a 9% increased risk of coronary events and a 9% increased risk of cardiovascular events, especially myocardial infarction,” Kole said.
“More research is needed to identify the cause of the apparent increased cardiovascular risk in people with a non-O blood group. Obtaining more information about risk in each non-O blood group (A, B, and AB) might provide further explanations of the causes.”
“In future, blood group should be considered in risk assessment for cardiovascular prevention, together with cholesterol, age, sex, and systolic blood pressure. It could be that people with an A blood group should have a lower treatment threshold for dyslipidemia or hypertension, for example. We need further studies to validate if the excess cardiovascular risk in non-O blood group carriers may be amenable to treatment.”
PARIS—Having a blood type other than O is associated with a higher risk of heart attack, according to a meta-analysis.
“It has been suggested that people with non-O blood groups (A, B, AB) are at higher risk for heart attacks and overall cardiovascular mortality, but this suggestion comes from case-control studies, which have a low level of evidence,” said Tessa Kole, a student at the University Medical Centre Groningen in the Netherlands.
Therefore, Kole and her fellow investigators conducted a meta-analysis of prospective studies reporting on blood groups and incident cardiovascular events.
The team presented their findings at Heart Failure 2017 and the 4th World Congress on Acute Heart Failure (abstract 697).
The study included 1,362,569 subjects from 11 prospective cohorts, described in 9 articles. There were a total of 23,154 cardiovascular events.
The investigators analyzed the association between blood group and all coronary events, combined cardiovascular events, and fatal coronary events.
The analysis of all coronary events included 771,113 subjects with a non-O blood group and 519,743 with an O blood group, of whom 11,437 (1.5%) and 7220 (1.4%), respectively, suffered a coronary event.
The odds ratio (OR) for all coronary events was significantly higher in subjects with a non-O blood group, at 1.09 (95% confidence interval [CI], 1.06-1.13, P<0.00001).
The analysis of combined cardiovascular events included 708,276 subjects with a non-O blood group and 476,868 with an O blood group, of whom 17,449 (2.5%) and 10,916 (2.3%), respectively, had an event.
The OR for combined cardiovascular events was significantly higher in subjects with non-O blood groups, at 1.09 (95% CI, 1.06-1.11, P=0.006).
The analysis of fatal coronary events did not show a significant difference between people with O and non-O blood groups. The OR was 1.00 (95% CI, 0.85-1.18, P=0.98).
“We demonstrate that having a non-O blood group is associated with a 9% increased risk of coronary events and a 9% increased risk of cardiovascular events, especially myocardial infarction,” Kole said.
“More research is needed to identify the cause of the apparent increased cardiovascular risk in people with a non-O blood group. Obtaining more information about risk in each non-O blood group (A, B, and AB) might provide further explanations of the causes.”
“In future, blood group should be considered in risk assessment for cardiovascular prevention, together with cholesterol, age, sex, and systolic blood pressure. It could be that people with an A blood group should have a lower treatment threshold for dyslipidemia or hypertension, for example. We need further studies to validate if the excess cardiovascular risk in non-O blood group carriers may be amenable to treatment.”
Drug receives orphan designation for AML
The US Food and Drug Administration (FDA) has granted orphan drug designation for PTX-200 for the treatment of acute myeloid leukemia (AML).
PTX-200, or triciribine phosphate monohydrate, is a small-molecule Akt inhibitor being developed by Prescient Therapeutics Ltd.
PTX-200 is currently being tested in combination with cytarabine in a phase 1b/2 trial of patients with relapsed or refractory AML.
PTX-200 was previously tested as monotherapy in a phase 1 trial of patients with relapsed or refractory hematologic malignancies.
Results from this trial were published in Leukemia Research in November 2013.
The trial included 41 patients who received at least 1 dose of PTX-200. The patients’ median age was 70 (range, of 23–83), and most (77%) were male.
Thirty-six patients (84%) had AML, 3 had myelodysplastic syndromes/chronic myelomonocytic leukemia (CMML), 2 had chronic lymphocytic leukemia, and 2 had acute lymphoblastic leukemia.
The patients had received a median of 2 prior therapies (range, 0–11), and they received a median of 1 cycle (range, 0–3) of PTX-200 at varying doses.
The maximum-tolerated dose of PTX-200 was 55 mg/m2. Two dose-limiting toxicities (DLTs) occurred in 3 patients in the 65 mg/m2 cohort (2 cases of lipase elevation and 1 case of triglyceride elevation).
One dose-limiting toxicity (mucositis) occurred in the 35 mg/m2 cohort. All DLTs resolved after patients stopped taking PTX-200.
Common treatment-emergent grade 3/4 adverse events included infection/febrile neutropenia (24%), bleeding (2%), mucositis (2%), and elevated lipase (5%).
Thirty-two patients were evaluable for response. There were no responses, but 17 patients had stable disease. The remaining 15 patients progressed.
Three patients with stable disease (all with AML) achieved at least a 50% reduction in bone marrow blasts, and a patient with CMML experienced spleen reduction and resolution of leukocytosis.
About orphan designation
The FDA grants orphan designation to products intended to treat, diagnose, or prevent rare diseases/disorders affecting fewer than 200,000 people in the US.
Orphan designation provides companies with certain incentives to develop products for rare diseases. This includes a 50% tax break on research and development, a fee waiver, access to federal grants, and 7 years of market exclusivity if the product is approved.
The US Food and Drug Administration (FDA) has granted orphan drug designation for PTX-200 for the treatment of acute myeloid leukemia (AML).
PTX-200, or triciribine phosphate monohydrate, is a small-molecule Akt inhibitor being developed by Prescient Therapeutics Ltd.
PTX-200 is currently being tested in combination with cytarabine in a phase 1b/2 trial of patients with relapsed or refractory AML.
PTX-200 was previously tested as monotherapy in a phase 1 trial of patients with relapsed or refractory hematologic malignancies.
Results from this trial were published in Leukemia Research in November 2013.
The trial included 41 patients who received at least 1 dose of PTX-200. The patients’ median age was 70 (range, of 23–83), and most (77%) were male.
Thirty-six patients (84%) had AML, 3 had myelodysplastic syndromes/chronic myelomonocytic leukemia (CMML), 2 had chronic lymphocytic leukemia, and 2 had acute lymphoblastic leukemia.
The patients had received a median of 2 prior therapies (range, 0–11), and they received a median of 1 cycle (range, 0–3) of PTX-200 at varying doses.
The maximum-tolerated dose of PTX-200 was 55 mg/m2. Two dose-limiting toxicities (DLTs) occurred in 3 patients in the 65 mg/m2 cohort (2 cases of lipase elevation and 1 case of triglyceride elevation).
One dose-limiting toxicity (mucositis) occurred in the 35 mg/m2 cohort. All DLTs resolved after patients stopped taking PTX-200.
Common treatment-emergent grade 3/4 adverse events included infection/febrile neutropenia (24%), bleeding (2%), mucositis (2%), and elevated lipase (5%).
Thirty-two patients were evaluable for response. There were no responses, but 17 patients had stable disease. The remaining 15 patients progressed.
Three patients with stable disease (all with AML) achieved at least a 50% reduction in bone marrow blasts, and a patient with CMML experienced spleen reduction and resolution of leukocytosis.
About orphan designation
The FDA grants orphan designation to products intended to treat, diagnose, or prevent rare diseases/disorders affecting fewer than 200,000 people in the US.
Orphan designation provides companies with certain incentives to develop products for rare diseases. This includes a 50% tax break on research and development, a fee waiver, access to federal grants, and 7 years of market exclusivity if the product is approved.
The US Food and Drug Administration (FDA) has granted orphan drug designation for PTX-200 for the treatment of acute myeloid leukemia (AML).
PTX-200, or triciribine phosphate monohydrate, is a small-molecule Akt inhibitor being developed by Prescient Therapeutics Ltd.
PTX-200 is currently being tested in combination with cytarabine in a phase 1b/2 trial of patients with relapsed or refractory AML.
PTX-200 was previously tested as monotherapy in a phase 1 trial of patients with relapsed or refractory hematologic malignancies.
Results from this trial were published in Leukemia Research in November 2013.
The trial included 41 patients who received at least 1 dose of PTX-200. The patients’ median age was 70 (range, of 23–83), and most (77%) were male.
Thirty-six patients (84%) had AML, 3 had myelodysplastic syndromes/chronic myelomonocytic leukemia (CMML), 2 had chronic lymphocytic leukemia, and 2 had acute lymphoblastic leukemia.
The patients had received a median of 2 prior therapies (range, 0–11), and they received a median of 1 cycle (range, 0–3) of PTX-200 at varying doses.
The maximum-tolerated dose of PTX-200 was 55 mg/m2. Two dose-limiting toxicities (DLTs) occurred in 3 patients in the 65 mg/m2 cohort (2 cases of lipase elevation and 1 case of triglyceride elevation).
One dose-limiting toxicity (mucositis) occurred in the 35 mg/m2 cohort. All DLTs resolved after patients stopped taking PTX-200.
Common treatment-emergent grade 3/4 adverse events included infection/febrile neutropenia (24%), bleeding (2%), mucositis (2%), and elevated lipase (5%).
Thirty-two patients were evaluable for response. There were no responses, but 17 patients had stable disease. The remaining 15 patients progressed.
Three patients with stable disease (all with AML) achieved at least a 50% reduction in bone marrow blasts, and a patient with CMML experienced spleen reduction and resolution of leukocytosis.
About orphan designation
The FDA grants orphan designation to products intended to treat, diagnose, or prevent rare diseases/disorders affecting fewer than 200,000 people in the US.
Orphan designation provides companies with certain incentives to develop products for rare diseases. This includes a 50% tax break on research and development, a fee waiver, access to federal grants, and 7 years of market exclusivity if the product is approved.
Simplifying consent forms doesn’t affect patient comprehension
Simplifying consent documents does not affect how well potential participants understand a clinical trial, according to new research.
The study showed no significant difference in comprehension between patients who read a concise consent document and those who read a longer document written at a more advanced reading level.
However, researchers did find that mailing consent forms to patients in advance and explaining the study to patients in person did improve their comprehension.
Christine Grady, PhD, of the NIH Clinical Center in Bethesda, Maryland, and her colleagues reported these findings in PLOS ONE.
The team noted that informed consent is a central tenet of ethical clinical research. However, over time, the documents used to obtain informed consent have grown longer, more complex, and harder to read.
So the researchers developed a concise alternative to consent documents used in the multinational START trial.
The new document was shorter than the old document by almost 70%, at 1821 words. The new document also contained bullet points and tables and had a simpler reading level.
Dr Grady and her colleagues tested the old and new documents with 4229 HIV-positive patients treated at 77 sites seeking enrollment in the START trial between 2009 and 2013.
The sites were randomly allocated to either the concise or the standard consent documents for participants to review.
There was no significant difference in comprehension scores between patients who received the concise form and those who received the standard form (P>0.1). Likewise, there was no significant difference in patient satisfaction or willingness to volunteer (P>0.1).
However, patients who received the concise form were significantly less likely to say the form was too long or too detailed (P<0.001).
The researchers did find several factors that were associated with significantly better comprehension.
Patients had significantly (P<0.05) better comprehension scores if they had a higher education level, were white, were treated at sites with more previous HIV studies, and were treated at sites where staff explained the study and thought patients understood the study very well.
Patients had significantly lower comprehension scores if they were treated at sites that rarely or never mailed the consent form ahead of the clinic visit (P=0.009).
Simplifying consent documents does not affect how well potential participants understand a clinical trial, according to new research.
The study showed no significant difference in comprehension between patients who read a concise consent document and those who read a longer document written at a more advanced reading level.
However, researchers did find that mailing consent forms to patients in advance and explaining the study to patients in person did improve their comprehension.
Christine Grady, PhD, of the NIH Clinical Center in Bethesda, Maryland, and her colleagues reported these findings in PLOS ONE.
The team noted that informed consent is a central tenet of ethical clinical research. However, over time, the documents used to obtain informed consent have grown longer, more complex, and harder to read.
So the researchers developed a concise alternative to consent documents used in the multinational START trial.
The new document was shorter than the old document by almost 70%, at 1821 words. The new document also contained bullet points and tables and had a simpler reading level.
Dr Grady and her colleagues tested the old and new documents with 4229 HIV-positive patients treated at 77 sites seeking enrollment in the START trial between 2009 and 2013.
The sites were randomly allocated to either the concise or the standard consent documents for participants to review.
There was no significant difference in comprehension scores between patients who received the concise form and those who received the standard form (P>0.1). Likewise, there was no significant difference in patient satisfaction or willingness to volunteer (P>0.1).
However, patients who received the concise form were significantly less likely to say the form was too long or too detailed (P<0.001).
The researchers did find several factors that were associated with significantly better comprehension.
Patients had significantly (P<0.05) better comprehension scores if they had a higher education level, were white, were treated at sites with more previous HIV studies, and were treated at sites where staff explained the study and thought patients understood the study very well.
Patients had significantly lower comprehension scores if they were treated at sites that rarely or never mailed the consent form ahead of the clinic visit (P=0.009).
Simplifying consent documents does not affect how well potential participants understand a clinical trial, according to new research.
The study showed no significant difference in comprehension between patients who read a concise consent document and those who read a longer document written at a more advanced reading level.
However, researchers did find that mailing consent forms to patients in advance and explaining the study to patients in person did improve their comprehension.
Christine Grady, PhD, of the NIH Clinical Center in Bethesda, Maryland, and her colleagues reported these findings in PLOS ONE.
The team noted that informed consent is a central tenet of ethical clinical research. However, over time, the documents used to obtain informed consent have grown longer, more complex, and harder to read.
So the researchers developed a concise alternative to consent documents used in the multinational START trial.
The new document was shorter than the old document by almost 70%, at 1821 words. The new document also contained bullet points and tables and had a simpler reading level.
Dr Grady and her colleagues tested the old and new documents with 4229 HIV-positive patients treated at 77 sites seeking enrollment in the START trial between 2009 and 2013.
The sites were randomly allocated to either the concise or the standard consent documents for participants to review.
There was no significant difference in comprehension scores between patients who received the concise form and those who received the standard form (P>0.1). Likewise, there was no significant difference in patient satisfaction or willingness to volunteer (P>0.1).
However, patients who received the concise form were significantly less likely to say the form was too long or too detailed (P<0.001).
The researchers did find several factors that were associated with significantly better comprehension.
Patients had significantly (P<0.05) better comprehension scores if they had a higher education level, were white, were treated at sites with more previous HIV studies, and were treated at sites where staff explained the study and thought patients understood the study very well.
Patients had significantly lower comprehension scores if they were treated at sites that rarely or never mailed the consent form ahead of the clinic visit (P=0.009).
Which Diet for Type 2 Diabetes?
Prescribed diets can be trying for both patients and providers; patients often struggle to adhere to them, and providers must determine which plan is suitable for which patient. The optimal diet for patients with diabetes—and whether it is sustainable—remains controversial.
A plant-based diet high in polyunsaturated and monounsaturated fats, with limited saturated fat and avoidance of trans-fatty acids, is supported by the American Association of Clinical Endocrinologists. Caloric restriction is recommended when weight loss is appropriate.1 The American Diabetes Association (ADA) recommends a Mediterranean-style diet rich in monounsaturated fats with carbohydrates from whole grains, vegetables, fruits, legumes, and dairy products, and an emphasis on foods higher in fiber and lower in glycemic load.2
Additionally, the ADA, the American Association of Diabetes Educators, and the Academy of Nutrition and Dietetics advise that all individuals with diabetes receive individualized Medical Nutrition Therapy (MNT), preferably with a registered dietitian nutritionist (RDN) knowledgeable and skilled in providing diabetes-specific nutrition education. MNT delivered by an RDN has been shown to reduce A1C levels by up to 2% in people with type 2 diabetes (T2DM).3
This flexibility in recommendations creates uncertainty about the correct dietary choice. Several diet plans are endorsed for the management of diabetes, including Mediterranean, low carbohydrate, Paleolithic, vegan, high fiber, and glycemic index (GI). Which should your patients adhere to? Several randomized controlled trials (RCTs), meta-analyses, and literature reviews have examined and compared the benefits of these eating habits for management of diabetes.
MEDITERRANEAN
The Mediterranean diet incorporates plant foods such as greens, tomatoes, onions, garlic, herbs, whole grains, legumes, nuts, and olive oil as the primary source of fat. A crossover trial of adults with T2DM demonstrated a statistically significant A1C reduction (from 7.1% to 6.8%) after 12 weeks on the Mediterranean diet.4
In a systematic review of 20 RCTs, Ajala et al analyzed data for nearly 3,500 patients with T2DM who adhered to either a low-carbohydrate, vegetarian, vegan, low-GI, high-fiber, Mediterranean, or high-protein diet for at least six months. The researchers found that Mediterranean, low-carbohydrate, low-GI, and high-protein diets all led to A1C reductions—but the largest reduction was observed with patients on the Mediterranean diet. Low-carbohydrate and Mediterranean diets resulted in the most weight loss.5
LOW-CARBOHYDRATE
Low-carbohydrate diets have decreased in popularity due to concerns about their effects on renal function, possible lack of nutrients, and speculation that their macronutrient composition may have effects on weight beyond those explained by caloric deficit. A meta-analysis of 13 studies of adults with T2DM following a low-carbohydrate diet (≤ 45% of calories from carbohydrates) demonstrated beneficial effects on fasting glucose, A1C, and triglyceride levels. Nine of the studies evaluated glycemic control and found A1C reduction with lower carbohydrate diets; the greatest reductions in A1C and triglycerides were correlated with the lowest carbohydrate intakes. No significant effects were seen for total, HDL, or LDL cholesterol.6
In the literature review by Ajala et al, low-carbohydrate, low-GI, and Mediterranean diets all improved lipid profiles. HDL cholesterol increased the most with a low-carbohydrate diet.5
A two-week study of 10 adults with T2DM found that just one week on a low-carbohydrate diet decreased the average 24-h plasma glucose from 135 mg/dL to 113 mg/dL. Over the two-week study period, triglycerides decreased by 35%, cholesterol by 10%, and A1C by 0.5%. Patients were allowed to consume as much protein and fat as desired. Food sources included beef and ground turkey patties, chicken breasts, turkey, ham, steamed vegetables, butter, diet gelatin, and a limited amount of cheese. Mean calorie intake decreased from 3,111 to 2,164 calories/d. Carbohydrate intake decreased from 300 to 20 g/d. Weight loss was entirely explained by the mean energy deficit.6 Patients experienced no difference in hunger, satisfaction, or energy level with a low-carb diet compared to their usual diet.7
A literature review of six studies examined the effects of low-carb diets (between 20-95 g/d) on body weight and A1C in patients with T2DM. Three of the studies restricted carbohydrate intake to less than 50 g/d. All reported reductions in body weight and A1C. In two studies, the majority of the weight loss was explained by a decrease in body fat, not loss of water weight. No deleterious effects on cardiovascular disease risk, renal function, or nutritional intake were seen. The researchers concluded that low-carb diets are safe and effective over the short term for people with T2DM.8
PALEOLITHIC
The Paleolithic diet (also referred to as the caveman diet, Stone Age diet, and hunter-gatherer diet) involves eating foods believed to have been available to humans before agriculture—this period began about 2.5 million years ago and ended about 100,000 years ago. Food sources include wild animal meat (lean meat and fish) and uncultivated plant foods (vegetables, fruits, roots, eggs, and nuts). It excludes grains, legumes, dairy products, salt, refined sugar, and processed oils.
In a randomized crossover study of 13 participants with T2DM, the Paleolithic diet improved glucose control and several cardiovascular disease markers, compared to a standard diabetes diet. The Paleolithic diet resulted in significantly lower A1C, triglycerides, diastolic blood pressure, body weight, BMI, and waist circumference, as well as increased HDL. Despite receiving no instruction to restrict calories, patients on the Paleolithic diet consumed fewer calories and carbohydrates, and more protein and fat, than those on the standard diabetes diet. The caloric deficit accounted almost exactly for the observed difference in weight loss between the two groups.9
GLYCEMIC INDEX
The GI measures the blood glucose level increase in the two hours after eating a particular food, with 100 representing the effect of glucose consumption. Low-GI food sources include beans, peas, lentils, pasta, pumpernickel bread, bulgur, parboiled rice, barley, and oats, while high-GI foods include potatoes, wheat flour, white bread, most breakfast cereals, and rice.
A meta-analysis compared the effects of high- and low-GI diets on glycemic control in 356 patients with diabetes. Ten of 14 studies documented improvements in A1C and postprandial plasma glucose with lower GI diets. Low-GI diets reduced A1C by 0.43% after an average duration of 10 weeks. The average GI was 83 for high-GI diets and 65 for low-GI diets. The researchers concluded that selecting low-GI foods has a small but clinically relevant effect on medium-term glycemic control, similar to that offered by medications that target postprandial blood glucose excursions.10
Low-GI diets resulted in lower A1C and higher HDL but no significant change in weight, according to Ajala et al.5
HIGH-FIBER
A survey of 15 studies examined the relationship between fiber intake and glycemic control. Interventions ranged from an additional 4 to 40 g of fiber per day, with a mean increase of 18.3 g/d. Additional fiber lowered A1C by 0.26% in 3 to 12 weeks, compared to placebo. The overall mean fasting blood glucose reduction was 15.32 mg/dL. No study lasted more than 12 weeks, but it is inferred that a longer study could result in a greater A1C reduction. Current dietary guidelines for patients with diabetes exceed the amount of fiber included in most of these studies.11
VEGAN
Ajala et al observed that patients on a vegan diet had lower total cholesterol, LDL, and A1C levels, compared to those on a low-fat diet. At 18 months, the vegetarian diet demonstrated improvement in glucose control and lipids, but not weight loss.5
In one RCT, a low-fat vegan diet was shown to improve glycemic control and lipid levels more than a conventional diabetes diet did. A1C decreased by 1.23% over 22 weeks, compared to 0.38% in the conventional diet group. Body weight decreased by 6.5 kg and LDL cholesterol decreased by 21.2% with the vegan diet, compared with a weight loss of 3.1 kg and a 10.7% LDL reduction in the conventional diet group.12
Patients on the vegan diet derived energy primarily from carbohydrates (75%), protein (15%), and fat (10%) by eating fruits, vegetables, grains, and legumes. Portion size and caloric and carbohydrate intake were not restricted. The conventional diet involved a caloric intake mainly from a combination of carbohydrates and monounsaturated fats (60% to 70%), protein (15% to 20%), and saturated fat (< 7%). The diet was individualized based on caloric needs and participants’ lipid levels. All participants were given calorie intake deficits of 500 to 1000 kcal/d.13 Participants rated both diets as satisfactory, with no significant differences between groups. The researchers concluded that a low-fat vegan diet has acceptability similar to that of a more conventional diabetes diet.12
CONCLUSION
Diabetes management strategies may incorporate a variety of dietary plans. While study populations are small and study durations relatively short, the aforementioned diets show improvement in biochemical markers such as fasting glucose, A1C, and lipid levels. The Mediterranean diet is believed to be sustainable over the long term, given the duration of time that people in the region have survived on it. Low-carbohydrate diets, including the Atkins and Paleolithic diets, are very effective at lowering A1C and triglycerides. Vegetarian/vegan diets may be more acceptable to patients than previously thought.
The long-term impact of any eating pattern will likely relate to adherence; adherence is more likely when patients find a diet to be acceptable, palatable, and easy to prepare. Diet selection should incorporate patient preferences and lifestyle choices, and when possible, should involve an RDN with expertise in diabetes.
1. American Association of Clinical Endocrinologists; American College of Endocrinology. Consensus statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the comprehensive type 2 diabetes management algorithm. Endocr Pract. 2016;22(1):84-113.
2. American Diabetes Association. Standards of medical care in diabetes—2016. Clin Diabetes. 2016;34(1):3-21.
3. Powers MA, Bardsley J, Cypress M, et al. Diabetes self-management education and support in type 2 diabetes: a joint position statement of the American Diabetes Association, the American Association of Diabetes Educators, and the Academy of Nutrition. J Acad Nutr Diet. 2015:115(8):1323-1334.
4. Itsiopoulos C, Brazionis L, Kaimakamis M, et al. Can the Mediterranean diet lower HbA1c in type 2 diabetes? Results from a randomized cross-over study. Nutr Metab Cardiovasc Dis. 2011;21(9):740-747.
5. Ajala O, English P, Pinkney J. Systematic review and meta-analysis of different dietary approaches to the management of type 2 diabetes. Am J Clin Nutr. 2013;97(3):505-516.
6. Boden G, Sargrad K, Homko C, et al. Effect of a low-carbohydrate diet on appetite, blood glucose levels, and insulin resistance in obese patients with type 2 diabetes. Ann Intern Med. 2005;142(6):403-411.
7. Kirk JK, Graves DE, Craven TE, et al. Restricted-carbohydrate diets in patients with type 2 diabetes: a meta-analysis. J Am Diet Assoc. 2008;108(1):91-100.
8. Dyson PA. A review of low and reduced carbohydrate diets and weight loss in type 2 diabetes. J Hum Nutr Diet. 2008;21(6):530-538.
9. Jönsson T, Granfeldt Y, Ahrén B, et al. Beneficial effects of a Paleolithic diet on cardiovascular risk factors in type 2 diabetes: a randomized cross-over pilot study. Cardiovasc Diabetol. 2009;8:35.
10. Brand-Miller J, Hayne S, Petocz P, et al. Low-glycemic index diets in the management of diabetes: a meta-analysis of randomized controlled trials. Diabetes Care. 2003;26(8):2261-2267.
11. Post RE, Mainous AG III, King DE, Simpson KN. Dietary fiber for the treatment of type 2 diabetes mellitus: a meta-analysis. J Am Board Fam Med. 2012;25(1):16-23.
12. Barnard ND, Gloede L, Cohen J, et al. A low-fat vegan diet elicits greater macronutrient changes, but is comparable in adherence and acceptability, compared with a more conventional diabetes diet among individuals with type 2 diabetes. J Am Diet Assoc. 2009;109(2):263-272.
13. Barnard ND, Cohen J, Jenkins DJA, et al. A low-fat vegan diet and a conventional diabetes diet in the treatment of type 2 diabetes: a randomized, controlled, 74-week clinical trial. Am J Clin Nutr. 2009;89(5):1588S-1596S.
Clinician Reviews in partnership with
Karen Beer practices at the Oregon Medical Group in Eugene.
Clinician Reviews in partnership with
Karen Beer practices at the Oregon Medical Group in Eugene.
Clinician Reviews in partnership with
Karen Beer practices at the Oregon Medical Group in Eugene.
Prescribed diets can be trying for both patients and providers; patients often struggle to adhere to them, and providers must determine which plan is suitable for which patient. The optimal diet for patients with diabetes—and whether it is sustainable—remains controversial.
A plant-based diet high in polyunsaturated and monounsaturated fats, with limited saturated fat and avoidance of trans-fatty acids, is supported by the American Association of Clinical Endocrinologists. Caloric restriction is recommended when weight loss is appropriate.1 The American Diabetes Association (ADA) recommends a Mediterranean-style diet rich in monounsaturated fats with carbohydrates from whole grains, vegetables, fruits, legumes, and dairy products, and an emphasis on foods higher in fiber and lower in glycemic load.2
Additionally, the ADA, the American Association of Diabetes Educators, and the Academy of Nutrition and Dietetics advise that all individuals with diabetes receive individualized Medical Nutrition Therapy (MNT), preferably with a registered dietitian nutritionist (RDN) knowledgeable and skilled in providing diabetes-specific nutrition education. MNT delivered by an RDN has been shown to reduce A1C levels by up to 2% in people with type 2 diabetes (T2DM).3
This flexibility in recommendations creates uncertainty about the correct dietary choice. Several diet plans are endorsed for the management of diabetes, including Mediterranean, low carbohydrate, Paleolithic, vegan, high fiber, and glycemic index (GI). Which should your patients adhere to? Several randomized controlled trials (RCTs), meta-analyses, and literature reviews have examined and compared the benefits of these eating habits for management of diabetes.
MEDITERRANEAN
The Mediterranean diet incorporates plant foods such as greens, tomatoes, onions, garlic, herbs, whole grains, legumes, nuts, and olive oil as the primary source of fat. A crossover trial of adults with T2DM demonstrated a statistically significant A1C reduction (from 7.1% to 6.8%) after 12 weeks on the Mediterranean diet.4
In a systematic review of 20 RCTs, Ajala et al analyzed data for nearly 3,500 patients with T2DM who adhered to either a low-carbohydrate, vegetarian, vegan, low-GI, high-fiber, Mediterranean, or high-protein diet for at least six months. The researchers found that Mediterranean, low-carbohydrate, low-GI, and high-protein diets all led to A1C reductions—but the largest reduction was observed with patients on the Mediterranean diet. Low-carbohydrate and Mediterranean diets resulted in the most weight loss.5
LOW-CARBOHYDRATE
Low-carbohydrate diets have decreased in popularity due to concerns about their effects on renal function, possible lack of nutrients, and speculation that their macronutrient composition may have effects on weight beyond those explained by caloric deficit. A meta-analysis of 13 studies of adults with T2DM following a low-carbohydrate diet (≤ 45% of calories from carbohydrates) demonstrated beneficial effects on fasting glucose, A1C, and triglyceride levels. Nine of the studies evaluated glycemic control and found A1C reduction with lower carbohydrate diets; the greatest reductions in A1C and triglycerides were correlated with the lowest carbohydrate intakes. No significant effects were seen for total, HDL, or LDL cholesterol.6
In the literature review by Ajala et al, low-carbohydrate, low-GI, and Mediterranean diets all improved lipid profiles. HDL cholesterol increased the most with a low-carbohydrate diet.5
A two-week study of 10 adults with T2DM found that just one week on a low-carbohydrate diet decreased the average 24-h plasma glucose from 135 mg/dL to 113 mg/dL. Over the two-week study period, triglycerides decreased by 35%, cholesterol by 10%, and A1C by 0.5%. Patients were allowed to consume as much protein and fat as desired. Food sources included beef and ground turkey patties, chicken breasts, turkey, ham, steamed vegetables, butter, diet gelatin, and a limited amount of cheese. Mean calorie intake decreased from 3,111 to 2,164 calories/d. Carbohydrate intake decreased from 300 to 20 g/d. Weight loss was entirely explained by the mean energy deficit.6 Patients experienced no difference in hunger, satisfaction, or energy level with a low-carb diet compared to their usual diet.7
A literature review of six studies examined the effects of low-carb diets (between 20-95 g/d) on body weight and A1C in patients with T2DM. Three of the studies restricted carbohydrate intake to less than 50 g/d. All reported reductions in body weight and A1C. In two studies, the majority of the weight loss was explained by a decrease in body fat, not loss of water weight. No deleterious effects on cardiovascular disease risk, renal function, or nutritional intake were seen. The researchers concluded that low-carb diets are safe and effective over the short term for people with T2DM.8
PALEOLITHIC
The Paleolithic diet (also referred to as the caveman diet, Stone Age diet, and hunter-gatherer diet) involves eating foods believed to have been available to humans before agriculture—this period began about 2.5 million years ago and ended about 100,000 years ago. Food sources include wild animal meat (lean meat and fish) and uncultivated plant foods (vegetables, fruits, roots, eggs, and nuts). It excludes grains, legumes, dairy products, salt, refined sugar, and processed oils.
In a randomized crossover study of 13 participants with T2DM, the Paleolithic diet improved glucose control and several cardiovascular disease markers, compared to a standard diabetes diet. The Paleolithic diet resulted in significantly lower A1C, triglycerides, diastolic blood pressure, body weight, BMI, and waist circumference, as well as increased HDL. Despite receiving no instruction to restrict calories, patients on the Paleolithic diet consumed fewer calories and carbohydrates, and more protein and fat, than those on the standard diabetes diet. The caloric deficit accounted almost exactly for the observed difference in weight loss between the two groups.9
GLYCEMIC INDEX
The GI measures the blood glucose level increase in the two hours after eating a particular food, with 100 representing the effect of glucose consumption. Low-GI food sources include beans, peas, lentils, pasta, pumpernickel bread, bulgur, parboiled rice, barley, and oats, while high-GI foods include potatoes, wheat flour, white bread, most breakfast cereals, and rice.
A meta-analysis compared the effects of high- and low-GI diets on glycemic control in 356 patients with diabetes. Ten of 14 studies documented improvements in A1C and postprandial plasma glucose with lower GI diets. Low-GI diets reduced A1C by 0.43% after an average duration of 10 weeks. The average GI was 83 for high-GI diets and 65 for low-GI diets. The researchers concluded that selecting low-GI foods has a small but clinically relevant effect on medium-term glycemic control, similar to that offered by medications that target postprandial blood glucose excursions.10
Low-GI diets resulted in lower A1C and higher HDL but no significant change in weight, according to Ajala et al.5
HIGH-FIBER
A survey of 15 studies examined the relationship between fiber intake and glycemic control. Interventions ranged from an additional 4 to 40 g of fiber per day, with a mean increase of 18.3 g/d. Additional fiber lowered A1C by 0.26% in 3 to 12 weeks, compared to placebo. The overall mean fasting blood glucose reduction was 15.32 mg/dL. No study lasted more than 12 weeks, but it is inferred that a longer study could result in a greater A1C reduction. Current dietary guidelines for patients with diabetes exceed the amount of fiber included in most of these studies.11
VEGAN
Ajala et al observed that patients on a vegan diet had lower total cholesterol, LDL, and A1C levels, compared to those on a low-fat diet. At 18 months, the vegetarian diet demonstrated improvement in glucose control and lipids, but not weight loss.5
In one RCT, a low-fat vegan diet was shown to improve glycemic control and lipid levels more than a conventional diabetes diet did. A1C decreased by 1.23% over 22 weeks, compared to 0.38% in the conventional diet group. Body weight decreased by 6.5 kg and LDL cholesterol decreased by 21.2% with the vegan diet, compared with a weight loss of 3.1 kg and a 10.7% LDL reduction in the conventional diet group.12
Patients on the vegan diet derived energy primarily from carbohydrates (75%), protein (15%), and fat (10%) by eating fruits, vegetables, grains, and legumes. Portion size and caloric and carbohydrate intake were not restricted. The conventional diet involved a caloric intake mainly from a combination of carbohydrates and monounsaturated fats (60% to 70%), protein (15% to 20%), and saturated fat (< 7%). The diet was individualized based on caloric needs and participants’ lipid levels. All participants were given calorie intake deficits of 500 to 1000 kcal/d.13 Participants rated both diets as satisfactory, with no significant differences between groups. The researchers concluded that a low-fat vegan diet has acceptability similar to that of a more conventional diabetes diet.12
CONCLUSION
Diabetes management strategies may incorporate a variety of dietary plans. While study populations are small and study durations relatively short, the aforementioned diets show improvement in biochemical markers such as fasting glucose, A1C, and lipid levels. The Mediterranean diet is believed to be sustainable over the long term, given the duration of time that people in the region have survived on it. Low-carbohydrate diets, including the Atkins and Paleolithic diets, are very effective at lowering A1C and triglycerides. Vegetarian/vegan diets may be more acceptable to patients than previously thought.
The long-term impact of any eating pattern will likely relate to adherence; adherence is more likely when patients find a diet to be acceptable, palatable, and easy to prepare. Diet selection should incorporate patient preferences and lifestyle choices, and when possible, should involve an RDN with expertise in diabetes.
Prescribed diets can be trying for both patients and providers; patients often struggle to adhere to them, and providers must determine which plan is suitable for which patient. The optimal diet for patients with diabetes—and whether it is sustainable—remains controversial.
A plant-based diet high in polyunsaturated and monounsaturated fats, with limited saturated fat and avoidance of trans-fatty acids, is supported by the American Association of Clinical Endocrinologists. Caloric restriction is recommended when weight loss is appropriate.1 The American Diabetes Association (ADA) recommends a Mediterranean-style diet rich in monounsaturated fats with carbohydrates from whole grains, vegetables, fruits, legumes, and dairy products, and an emphasis on foods higher in fiber and lower in glycemic load.2
Additionally, the ADA, the American Association of Diabetes Educators, and the Academy of Nutrition and Dietetics advise that all individuals with diabetes receive individualized Medical Nutrition Therapy (MNT), preferably with a registered dietitian nutritionist (RDN) knowledgeable and skilled in providing diabetes-specific nutrition education. MNT delivered by an RDN has been shown to reduce A1C levels by up to 2% in people with type 2 diabetes (T2DM).3
This flexibility in recommendations creates uncertainty about the correct dietary choice. Several diet plans are endorsed for the management of diabetes, including Mediterranean, low carbohydrate, Paleolithic, vegan, high fiber, and glycemic index (GI). Which should your patients adhere to? Several randomized controlled trials (RCTs), meta-analyses, and literature reviews have examined and compared the benefits of these eating habits for management of diabetes.
MEDITERRANEAN
The Mediterranean diet incorporates plant foods such as greens, tomatoes, onions, garlic, herbs, whole grains, legumes, nuts, and olive oil as the primary source of fat. A crossover trial of adults with T2DM demonstrated a statistically significant A1C reduction (from 7.1% to 6.8%) after 12 weeks on the Mediterranean diet.4
In a systematic review of 20 RCTs, Ajala et al analyzed data for nearly 3,500 patients with T2DM who adhered to either a low-carbohydrate, vegetarian, vegan, low-GI, high-fiber, Mediterranean, or high-protein diet for at least six months. The researchers found that Mediterranean, low-carbohydrate, low-GI, and high-protein diets all led to A1C reductions—but the largest reduction was observed with patients on the Mediterranean diet. Low-carbohydrate and Mediterranean diets resulted in the most weight loss.5
LOW-CARBOHYDRATE
Low-carbohydrate diets have decreased in popularity due to concerns about their effects on renal function, possible lack of nutrients, and speculation that their macronutrient composition may have effects on weight beyond those explained by caloric deficit. A meta-analysis of 13 studies of adults with T2DM following a low-carbohydrate diet (≤ 45% of calories from carbohydrates) demonstrated beneficial effects on fasting glucose, A1C, and triglyceride levels. Nine of the studies evaluated glycemic control and found A1C reduction with lower carbohydrate diets; the greatest reductions in A1C and triglycerides were correlated with the lowest carbohydrate intakes. No significant effects were seen for total, HDL, or LDL cholesterol.6
In the literature review by Ajala et al, low-carbohydrate, low-GI, and Mediterranean diets all improved lipid profiles. HDL cholesterol increased the most with a low-carbohydrate diet.5
A two-week study of 10 adults with T2DM found that just one week on a low-carbohydrate diet decreased the average 24-h plasma glucose from 135 mg/dL to 113 mg/dL. Over the two-week study period, triglycerides decreased by 35%, cholesterol by 10%, and A1C by 0.5%. Patients were allowed to consume as much protein and fat as desired. Food sources included beef and ground turkey patties, chicken breasts, turkey, ham, steamed vegetables, butter, diet gelatin, and a limited amount of cheese. Mean calorie intake decreased from 3,111 to 2,164 calories/d. Carbohydrate intake decreased from 300 to 20 g/d. Weight loss was entirely explained by the mean energy deficit.6 Patients experienced no difference in hunger, satisfaction, or energy level with a low-carb diet compared to their usual diet.7
A literature review of six studies examined the effects of low-carb diets (between 20-95 g/d) on body weight and A1C in patients with T2DM. Three of the studies restricted carbohydrate intake to less than 50 g/d. All reported reductions in body weight and A1C. In two studies, the majority of the weight loss was explained by a decrease in body fat, not loss of water weight. No deleterious effects on cardiovascular disease risk, renal function, or nutritional intake were seen. The researchers concluded that low-carb diets are safe and effective over the short term for people with T2DM.8
PALEOLITHIC
The Paleolithic diet (also referred to as the caveman diet, Stone Age diet, and hunter-gatherer diet) involves eating foods believed to have been available to humans before agriculture—this period began about 2.5 million years ago and ended about 100,000 years ago. Food sources include wild animal meat (lean meat and fish) and uncultivated plant foods (vegetables, fruits, roots, eggs, and nuts). It excludes grains, legumes, dairy products, salt, refined sugar, and processed oils.
In a randomized crossover study of 13 participants with T2DM, the Paleolithic diet improved glucose control and several cardiovascular disease markers, compared to a standard diabetes diet. The Paleolithic diet resulted in significantly lower A1C, triglycerides, diastolic blood pressure, body weight, BMI, and waist circumference, as well as increased HDL. Despite receiving no instruction to restrict calories, patients on the Paleolithic diet consumed fewer calories and carbohydrates, and more protein and fat, than those on the standard diabetes diet. The caloric deficit accounted almost exactly for the observed difference in weight loss between the two groups.9
GLYCEMIC INDEX
The GI measures the blood glucose level increase in the two hours after eating a particular food, with 100 representing the effect of glucose consumption. Low-GI food sources include beans, peas, lentils, pasta, pumpernickel bread, bulgur, parboiled rice, barley, and oats, while high-GI foods include potatoes, wheat flour, white bread, most breakfast cereals, and rice.
A meta-analysis compared the effects of high- and low-GI diets on glycemic control in 356 patients with diabetes. Ten of 14 studies documented improvements in A1C and postprandial plasma glucose with lower GI diets. Low-GI diets reduced A1C by 0.43% after an average duration of 10 weeks. The average GI was 83 for high-GI diets and 65 for low-GI diets. The researchers concluded that selecting low-GI foods has a small but clinically relevant effect on medium-term glycemic control, similar to that offered by medications that target postprandial blood glucose excursions.10
Low-GI diets resulted in lower A1C and higher HDL but no significant change in weight, according to Ajala et al.5
HIGH-FIBER
A survey of 15 studies examined the relationship between fiber intake and glycemic control. Interventions ranged from an additional 4 to 40 g of fiber per day, with a mean increase of 18.3 g/d. Additional fiber lowered A1C by 0.26% in 3 to 12 weeks, compared to placebo. The overall mean fasting blood glucose reduction was 15.32 mg/dL. No study lasted more than 12 weeks, but it is inferred that a longer study could result in a greater A1C reduction. Current dietary guidelines for patients with diabetes exceed the amount of fiber included in most of these studies.11
VEGAN
Ajala et al observed that patients on a vegan diet had lower total cholesterol, LDL, and A1C levels, compared to those on a low-fat diet. At 18 months, the vegetarian diet demonstrated improvement in glucose control and lipids, but not weight loss.5
In one RCT, a low-fat vegan diet was shown to improve glycemic control and lipid levels more than a conventional diabetes diet did. A1C decreased by 1.23% over 22 weeks, compared to 0.38% in the conventional diet group. Body weight decreased by 6.5 kg and LDL cholesterol decreased by 21.2% with the vegan diet, compared with a weight loss of 3.1 kg and a 10.7% LDL reduction in the conventional diet group.12
Patients on the vegan diet derived energy primarily from carbohydrates (75%), protein (15%), and fat (10%) by eating fruits, vegetables, grains, and legumes. Portion size and caloric and carbohydrate intake were not restricted. The conventional diet involved a caloric intake mainly from a combination of carbohydrates and monounsaturated fats (60% to 70%), protein (15% to 20%), and saturated fat (< 7%). The diet was individualized based on caloric needs and participants’ lipid levels. All participants were given calorie intake deficits of 500 to 1000 kcal/d.13 Participants rated both diets as satisfactory, with no significant differences between groups. The researchers concluded that a low-fat vegan diet has acceptability similar to that of a more conventional diabetes diet.12
CONCLUSION
Diabetes management strategies may incorporate a variety of dietary plans. While study populations are small and study durations relatively short, the aforementioned diets show improvement in biochemical markers such as fasting glucose, A1C, and lipid levels. The Mediterranean diet is believed to be sustainable over the long term, given the duration of time that people in the region have survived on it. Low-carbohydrate diets, including the Atkins and Paleolithic diets, are very effective at lowering A1C and triglycerides. Vegetarian/vegan diets may be more acceptable to patients than previously thought.
The long-term impact of any eating pattern will likely relate to adherence; adherence is more likely when patients find a diet to be acceptable, palatable, and easy to prepare. Diet selection should incorporate patient preferences and lifestyle choices, and when possible, should involve an RDN with expertise in diabetes.
1. American Association of Clinical Endocrinologists; American College of Endocrinology. Consensus statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the comprehensive type 2 diabetes management algorithm. Endocr Pract. 2016;22(1):84-113.
2. American Diabetes Association. Standards of medical care in diabetes—2016. Clin Diabetes. 2016;34(1):3-21.
3. Powers MA, Bardsley J, Cypress M, et al. Diabetes self-management education and support in type 2 diabetes: a joint position statement of the American Diabetes Association, the American Association of Diabetes Educators, and the Academy of Nutrition. J Acad Nutr Diet. 2015:115(8):1323-1334.
4. Itsiopoulos C, Brazionis L, Kaimakamis M, et al. Can the Mediterranean diet lower HbA1c in type 2 diabetes? Results from a randomized cross-over study. Nutr Metab Cardiovasc Dis. 2011;21(9):740-747.
5. Ajala O, English P, Pinkney J. Systematic review and meta-analysis of different dietary approaches to the management of type 2 diabetes. Am J Clin Nutr. 2013;97(3):505-516.
6. Boden G, Sargrad K, Homko C, et al. Effect of a low-carbohydrate diet on appetite, blood glucose levels, and insulin resistance in obese patients with type 2 diabetes. Ann Intern Med. 2005;142(6):403-411.
7. Kirk JK, Graves DE, Craven TE, et al. Restricted-carbohydrate diets in patients with type 2 diabetes: a meta-analysis. J Am Diet Assoc. 2008;108(1):91-100.
8. Dyson PA. A review of low and reduced carbohydrate diets and weight loss in type 2 diabetes. J Hum Nutr Diet. 2008;21(6):530-538.
9. Jönsson T, Granfeldt Y, Ahrén B, et al. Beneficial effects of a Paleolithic diet on cardiovascular risk factors in type 2 diabetes: a randomized cross-over pilot study. Cardiovasc Diabetol. 2009;8:35.
10. Brand-Miller J, Hayne S, Petocz P, et al. Low-glycemic index diets in the management of diabetes: a meta-analysis of randomized controlled trials. Diabetes Care. 2003;26(8):2261-2267.
11. Post RE, Mainous AG III, King DE, Simpson KN. Dietary fiber for the treatment of type 2 diabetes mellitus: a meta-analysis. J Am Board Fam Med. 2012;25(1):16-23.
12. Barnard ND, Gloede L, Cohen J, et al. A low-fat vegan diet elicits greater macronutrient changes, but is comparable in adherence and acceptability, compared with a more conventional diabetes diet among individuals with type 2 diabetes. J Am Diet Assoc. 2009;109(2):263-272.
13. Barnard ND, Cohen J, Jenkins DJA, et al. A low-fat vegan diet and a conventional diabetes diet in the treatment of type 2 diabetes: a randomized, controlled, 74-week clinical trial. Am J Clin Nutr. 2009;89(5):1588S-1596S.
1. American Association of Clinical Endocrinologists; American College of Endocrinology. Consensus statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the comprehensive type 2 diabetes management algorithm. Endocr Pract. 2016;22(1):84-113.
2. American Diabetes Association. Standards of medical care in diabetes—2016. Clin Diabetes. 2016;34(1):3-21.
3. Powers MA, Bardsley J, Cypress M, et al. Diabetes self-management education and support in type 2 diabetes: a joint position statement of the American Diabetes Association, the American Association of Diabetes Educators, and the Academy of Nutrition. J Acad Nutr Diet. 2015:115(8):1323-1334.
4. Itsiopoulos C, Brazionis L, Kaimakamis M, et al. Can the Mediterranean diet lower HbA1c in type 2 diabetes? Results from a randomized cross-over study. Nutr Metab Cardiovasc Dis. 2011;21(9):740-747.
5. Ajala O, English P, Pinkney J. Systematic review and meta-analysis of different dietary approaches to the management of type 2 diabetes. Am J Clin Nutr. 2013;97(3):505-516.
6. Boden G, Sargrad K, Homko C, et al. Effect of a low-carbohydrate diet on appetite, blood glucose levels, and insulin resistance in obese patients with type 2 diabetes. Ann Intern Med. 2005;142(6):403-411.
7. Kirk JK, Graves DE, Craven TE, et al. Restricted-carbohydrate diets in patients with type 2 diabetes: a meta-analysis. J Am Diet Assoc. 2008;108(1):91-100.
8. Dyson PA. A review of low and reduced carbohydrate diets and weight loss in type 2 diabetes. J Hum Nutr Diet. 2008;21(6):530-538.
9. Jönsson T, Granfeldt Y, Ahrén B, et al. Beneficial effects of a Paleolithic diet on cardiovascular risk factors in type 2 diabetes: a randomized cross-over pilot study. Cardiovasc Diabetol. 2009;8:35.
10. Brand-Miller J, Hayne S, Petocz P, et al. Low-glycemic index diets in the management of diabetes: a meta-analysis of randomized controlled trials. Diabetes Care. 2003;26(8):2261-2267.
11. Post RE, Mainous AG III, King DE, Simpson KN. Dietary fiber for the treatment of type 2 diabetes mellitus: a meta-analysis. J Am Board Fam Med. 2012;25(1):16-23.
12. Barnard ND, Gloede L, Cohen J, et al. A low-fat vegan diet elicits greater macronutrient changes, but is comparable in adherence and acceptability, compared with a more conventional diabetes diet among individuals with type 2 diabetes. J Am Diet Assoc. 2009;109(2):263-272.
13. Barnard ND, Cohen J, Jenkins DJA, et al. A low-fat vegan diet and a conventional diabetes diet in the treatment of type 2 diabetes: a randomized, controlled, 74-week clinical trial. Am J Clin Nutr. 2009;89(5):1588S-1596S.