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News and Trends—June 2016

| June 1, 2016

News from the American Diabetes Association

Consensus from Diabetes Organizations Worldwide: Metabolic Surgery Recognized as a Standard Treatment Option for Type 2 Diabetes
A Special Issue of Diabetes Care Reports First-Ever Clinical Guidelines for When to Recommend or Consider Metabolic Surgery as Treatment for People with Diabetes

Alexandria, Virginia—Metabolic, or weight-loss, surgery quickly and dramatically improves blood glucose control. Until now, however, it has not been included in clinical practice guidelines as a treatment option for people with diabetes. In a Joint Statement endorsed by 45 international professional organizations, diabetes clinicians and researchers are urging that metabolic surgery be recommended or considered as a treatment option for certain categories of people with diabetes, including people who are mildly obese and fail to respond to conventional treatment. The Statement and Clinical Guidelines will be published in the June 2016 issue of Diabetes Care, available in print and online.

“Given the rapid developments in the field, it is important to focus on this topic for those who care for individuals with diabetes. These new Guidelines, based on the results of multiple clinical studies, validate that metabolic surgery is indicated for certain people with diabetes and can yield significantly improved outcomes,” said Diabetes Care Editor in Chief William T. Cefalu, MD, adding that it is the first time guidelines recommend surgery as a treatment option specifically for diabetes.
The special Diabetes Care issue includes a Commentary, authored by Drs. Cefalu, Francesco Rubino and David E. Cummings, along with 10 research reports and the Consensus Statement endorsed by the American Diabetes Association.

The new Guidelines emerged from the Second Diabetes Surgery Summit (DSS-II), an international consensus conference held September 28–30, 2015, in London, and jointly organized with the American Diabetes Association (ADA), International Diabetes Federation (IDF), Diabetes UK (DUK), Chinese Diabetes Society (CDS), and Diabetes India (DI). The goal of the Summit was to develop global guidelines to inform clinicians and policy makers about the benefits and limitations of metabolic surgery for type 2 diabetes.

In the report, metabolic surgery is defined as the use of gastrointestinal operations, originally designed to induce weight loss (“bariatric surgery”), with the primary intent to treat type 2 diabetes and obesity. These procedures remove parts of the stomach or reroute the small intestine. Many people who undergo metabolic surgery experience major improvements in glycemia, as well as a reduction in cardiovascular risk factors, making it a highly effective treatment for type 2 diabetes and a highly effective means of diabetes prevention.

“Despite continuing advances in diabetes pharmacotherapy, fewer than half of adults with type 2 diabetes mellitus (T2D) attain therapeutic goals designed to reduce long-term risks of complications, especially for glycemic control, and lifestyle interventions are disappointing in the long term,” wrote the Guideline authors in the commentary. Metabolic surgery, on the other hand, has been shown to “improve glucose homeostasis more effectively than any known pharmaceutical or behavioral approach,” they wrote. Despite such evidence, to date, metabolic surgery had not been included in clinical guidelines for diabetes care as a recommended intervention.

According to the new Guidelines, metabolic surgery should be recommended to treat type 2 diabetes in patients with Class III obesity (BMI greater than or equal to 40 kg/m²), as well as in those with Class II obesity (BMI between 35 and 39.9 kg/m²) when hyperglycemia is inadequately controlled by lifestyle and medical therapy. It should also be considered for patients with type 2 diabetes who have a BMI between 30 and 34.9 kg/m² if hyperglycemia is inadequately controlled, the authors agreed. The Consensus Statement also recognizes that BMI thresholds in Asian patients, who develop type 2 diabetes at lower BMI than other populations, should be lowered 2.5 kg/m² for each of these categories.

These conclusions are based on a large body of evidence including 11 randomized clinical trials showing that in most cases surgery can either reduce blood sugar levels below diabetic thresholds (“diabetes remission”) or maintain adequate glycemic control despite major reduction in medication usage. While relapse of hyperglycemia may occur in up to 50% of patients with initial remission, most patients maintain substantial improvement of A1C long term, the authors noted.
“Surgery represents a radical departure from conventional approaches to diabetes. The new Guidelines effectively introduce, both conceptually and practically, one of the biggest changes for diabetes care in modern times,” said Dr. Francesco Rubino, a Professor of Metabolic and Bariatric Surgery at King’s College London in the UK, co-director of the DSS-II and the first author of the report. “This change is supported by documented clinical efficacy and by the evidence of an important role of the gut in metabolic regulation, which makes it an appropriate target for anti-diabetes interventions,” he added.

Economic studies also show that metabolic surgery is cost-effective. The authors of the new Guidelines recommend that health care regulators introduce appropriate reimbursement policies for metabolic surgery for people with type 2 diabetes.
Although metabolic surgery is similarly safe compared to commonly performed operations such as gallbladder surgery, there are still risks of complications and long-term nutritional deficiencies, which require lifelong vitamin/nutritional supplementation and rigorous long-term follow up by a multidisciplinary team with appropriate expertise. The report also identifies current gaps in knowledge and indicates priorities for research. In particular, long-term studies looking at cardiovascular endpoints and other diabetes complications in less obese people and adolescents are necessary to better refine the role of surgery in management algorithms.

Ten articles in the special issue include a report on the status of the pandemic of diabetes and metabolic surgery issues; the role of the gut in glucose homeostasis; the mechanisms of diabetes improvement following bariatric surgery; clinical outcomes of bariatric surgery; ethnic considerations for metabolic surgery; barriers to appropriate utilization of surgery; and reports on the potential for using weight-loss surgery as a treatment for youth with type 2 diabetes, obese patients with type 1 diabetes and those with only mild obesity.

The full articles, consensus statement and commentary are available at http://care.diabetesjournals.org/content/current

American Diabetes Association Applauds FDA’s Revised Nutrition Label Rules
Alexandria, Virginia—The American Diabetes Association applauds the changes to the Nutrition Facts label released by the Food and Drug Administration (FDA) on Friday, May 20, 2016. Accurate and easily understandable food labels are essential in ensuring individuals with and at risk for diabetes are able to follow their individualized eating plans and achieve their daily nutrition goals. The rule will require a line disclosing added sugars and increase the type size for the calories heading and numerical value. For people with diabetes especially, the requirement that typical portions be labeled as one serving is another important change.

Foods high in added sugars, such as sodas and sweets, are nutritionally inferior to foods high in naturally occurring sugars, such as fruit and milk. Requiring the disclosure of added sugars will help Americans make dietary decisions to reduce their consumption of added sugars, which is recommended by the 2015 Dietary Guidelines for Americans.

Increasing the prominence of the calorie declaration through a larger and bolder type will make it easier for Americans to identify and comprehend the number of calories per serving. For overweight and obese adults with type 2 diabetes, reducing calorie intake while maintaining a healthful eating pattern is recommended. Increasing the type size for the calories heading and numerical value will support individuals with and at risk for diabetes in selecting, preparing, and consuming food and beverages with the appropriate number of calories to meet their needs for weight management.

About The American Diabetes Association. The American Diabetes Association is leading the fight to Stop Diabetes and its deadly consequences and fighting for those affected by diabetes. The Association funds research to prevent, cure and manage diabetes; delivers services to hundreds of communities; provides objective and credible information; and gives voice to those denied their rights because of diabetes. Since 1940, our mission has been to prevent and cure diabetes and to improve the lives of all people affected by diabetes. For more information please call the American Diabetes Association at 1-800-DIABETES (800-342-2383) or visit diabetes.org.

Researchers suggest whole-person perspective is needed to assess obesity
Journal of the American Osteopathic Association review article suggests patient’s disease burden, other measures provide clearer picture of severity
Cleveland, Ohio—Authors from the Cleveland Clinic’s Bariatric and Metabolic Institute recommend physicians use obesity staging models to recognize and manage weight-related health issues that may not be captured by traditional diagnosis criteria. The review article was published in the Journal of the American Osteopathic Association.

The authors urge physicians to take a broader view of what constitutes obesity, which is traditionally defined as a body mass index (BMI) of 30 or greater.
“BMI doesn’t differentiate between lean muscle mass and fat mass, which can skew perceptions of weight in different patients,” said lead author Derrick Cetin, DO. For example, a younger athlete may have high muscle mass and lower body fat at a BMI of 27, while an older person with a BMI of 25 may have lost muscle due to aging and have higher body fat.”

Ethnic differences were also noted, including studies that found Asians had more than the double the risk of Type 2 diabetes than Caucasians with the same BMI and were at risk when BMI measured 22 to 25. The findings increase the potential usefulness of waist circumference measurements to identify metabolically obese and overweight patients whose BMI is normal.

“Waist circumference is a surrogate marker for intra-abdominal fat and can indicate metabolic syndrome, which affects about one of three adults in the United States. But you can’t properly diagnose metabolic syndrome without considering the ethnicity of the patient. Even with a condition as seemingly straightforward as obesity, physicians need to take a whole-person approach to understand the patient,” said Dr.Cetin, DO.

The staged approach to obesity treatment allows for intensive lifestyle modification and weight management at Obesity Stage 0, when patients are metabolically normal, to prevent disease progression which can lead to increased risk for negative physical and psychological health effects as well as limitation in daily activities.

A five percent to 10 percent weight loss through diet and increased physical activities is shown to result in a 30 percent greater loss of fat around internal organs, which substantially reduces the risk of adverse consequences, researchers noted.

Open access to the full review is available until August. Visit http://jaoa.org/article.aspx?articleid=2525750

About The Journal of the American Osteopathic Association. The Journal of the American Osteopathic Association (JAOA) is the official scientific publication of the American Osteopathic Association. Edited by Robert Orenstein, DO, it is the premier scholarly peer-reviewed publication of the osteopathic medical profession. The JAOA’s mission is to advance medicine through the publication of peer-reviewed osteopathic research.

Young adults with obesity unaware of kidney disease risk, study finds
BRONX, New York—Many young adults with abdominal obesity exhibit a readily detectable risk factor for chronic kidney disease (CKD), yet the vast majority don’t know they’re at risk, according to a study of nationwide health data led by Albert Einstein College of Medicine researchers that was published online in the journal PLOS ONE.

Einstein researchers analyzed health data on nearly 7,000 non-pregnant young adults. They found that 11 percent of obese Mexican Americans have albuminuria (elevated levels of the protein albumin in the urine), which signals that the kidneys aren’t functioning normally and that a person faces a heightened risk for developing CKD. This is four times the prevalence in Hispanics of normal weight. About six percent of whites and blacks with abdominal obesity had elevated levels of the protein.

An estimated one in three Americans is at risk for developing CKD over the course of their lifetime, usually later in adulthood. “Even though chronic kidney disease typically manifests in older people, the disease can start much earlier but often is not recognized early on,” said study leader Michal L. Melamed, M.D., associate professor of medicine and of epidemiology & public health at Einstein and attending physician, nephrology at Montefiore Health System. “Because treatment options for CKD are limited, prevention is the best approach for those at risk. A healthier lifestyle in young adults will go a long way toward promoting kidney health later in life.”

Previous studies had suggested that abdominal obesity may damage kidney function even before–and perhaps independent of–kidney damage associated with hypertension and diabetes, which are both associated with obesity.

“In this study we wanted to evaluate whether obesity is associated with CKD even in an otherwise healthy young adult population and to identify risk factors that may promote this association,” said first author Harini Sarathy, M.D., formerly a resident physician at Jacobi Medical Center, an Einstein clinical affiliate. “We also wanted to see whether race or ethnicity plays a role in linking abdominal obesity with CKD, as studies have suggested.”

The Einstein researchers found that excess albumin was present even in the urine of obese individuals with normal blood pressure, glucose levels, and insulin sensitivity, confirming a direct connection between obesity and the albuminuria associated with kidney disease. These findings also suggest that obesity should be considered an independent risk factor for CKD and that doctors should be testing for kidney damage when evaluating obese young adults.

The Einstein researchers analyzed health data on 6,918 non-pregnant adults ages 20 to 40. The data were gathered between 1999 and 2010 by the National Health and Nutrition Examination Survey (NHANES), a program of studies designed to assess the health and nutritional status of adults and children in the United States. The participants self-identified as non-Hispanic white, non-Hispanic black, or Mexican-American. Abdominal obesity (defined as a waist circumference ≥102 cm (40 inches) in males and ≥88 cm (35 inches) in females) was present in 45 percent of blacks, 40 percent of Mexican-Americans, and 37 percent of whites.

The study also found that among all young adults with albuminuria, fewer than 5 percent had ever been told they have kidney disease. “Clearly, clinicians and public health officials need to do more to identify and treat young people at risk for early progressive kidney disease so they can adopt the behavioral changes to prevent CKD from occurring,” said Dr. Melamed.

To view the article online, visit http://journals.plos.org/plosone/article?id=info%3Adoi%2F10.1371%2Fjournal.pone.0153588#sec006.

Prevalence of obesity in United States increases among women, but not men
The prevalence of obesity in 2013-2014 was 35 percent among men and 40 percent among women, and between 2005 and 2014, there was an increase in prevalence among women, but not men, according to a study appearing in the June 7 issue of JAMA.

Between 1980 and 2000, the prevalence of obesity increased significantly among adult men and women in the United States; further significant increases were observed through 2003-2004 for men but not women. Subsequent comparisons of data from 2003-2004 with data through 2011-2012 showed no significant increases for men or women. To get a more comprehensive understanding of the trends in obesity, Katherine M. Flegal, Ph.D., of the National Center for Health Statistics, Centers for Disease Control and Prevention, Hyattsville, Md., and colleagues examined obesity prevalence for 2013-2014 and trends over the decade from 2005 through 2014, adjusting for sex, age, race/Hispanic origin, smoking status, and education. The researchers analyzed data obtained from the National Health and Nutrition Examination Survey (NHANES), a cross-sectional, nationally representative health examination survey of the U.S. civilian population that includes measured weight and height.

The analysis included data from 2,638 adult men (average age, 47 years) and 2,817 women (average age, 48 years) from the most recent 2 years (2013-2014) of NHANES and data from 21,013 participants in previous NHANES surveys from 2005 through 2012. For the years 2013-2014, the overall age-adjusted prevalence of obesity (body mass index [BMI] 30 or greater) was 38 percent; among men, it was 35 percent; and among women, it was 40 percent. The corresponding prevalence of class 3 (BMI 40 or greater) obesity overall was 7.7 percent; among men, it was 5.5 percent; and among women, it was 9.9 percent. Analyses of changes over the decade from 2005 through 2014, adjusted for age, race/Hispanic origin, smoking status, and education, showed significant increasing linear trends among women for overall obesity and for class 3 obesity but not among men.
Analyses of the data from 2013-2014 found that for men, obesity prevalence varied by smoking status, with the prevalence of obesity significantly lower among current smokers than among never smokers. For women, there were no significant differences by smoking status, but those with education beyond high school were significantly less likely to be obese.

The authors write that although there has been considerable speculation about the causes of the increases in obesity prevalence, data are lacking to show the causes of these trends, and there are few data to indicate reasons that these trends might accelerate, stop, or slow. “Other studies are needed to determine the reasons for these trends.”
Access the article online at http://jama.jamanetwork.com/article.aspx?articleid=2526639

Dana-Farber and Fitbit partner to test if weight loss can prevent breast cancer recurrence
Boston, Massachusetts—Dana-Farber Cancer Institute and Fitbit announced a partnership to support a potentially ground-breaking study that investigates the impact of weight loss on breast cancer recurrence. The Breast Cancer Weight Loss (BWEL) study, sponsored by the National Cancer Institute and the Alliance for Clinical Trials in Oncology, will enroll nearly 3,200 overweight and obese women with early stage breast cancer to test if weight loss can help prevent their disease from returning. The study will begin in August 2016 and enroll women with breast cancer through oncology practices across the Unites States and Canada. Fitbit is donating specific products that will help participants stay motivated and engaged while tracking their weight loss journey and allow their coaches to make sure participants meet their weight loss and fitness goals.

According to the American Cancer Society, approximately 20% of women treated for breast cancer today experience a recurrence of the disease, with most of those women developing metastatic breast cancer. Excess body weight has long been linked to an increased risk of developing breast cancer, and growing evidence suggests that obesity is associated with poor prognosis in women diagnosed with early stage breast cancer. However, despite many reports supporting a relationship between weight and breast cancer prognosis, there have been no studies examining the effect of weight loss upon the risk of breast cancer recurrence.

“The increased risk of cancer recurrence linked to excess body weight threatens to limit our progress in treating breast cancer and preventing women from dying from this disease,” said Jennifer Ligibel, MD, a breast oncologist in the Susan F. Smith Center for Women’s Cancers at Dana-Farber, and lead investigator of the BWEL trial. “If this study shows that losing weight through increasing physical activity and reducing calories improves survival rates in breast cancer, this could lead to weight loss and physical activity becoming a standard part of the treatment for millions of breast cancer patients around the world.”

To help study investigators closely track activity and weight loss among study participants, each participant will receive a Fitbit Charge HRTM fitness tracker that delivers all-day activity tracking and continuous, wrist-based heart rate tracking. Participants will also receive a Fitbit Aria® Wi-Fi Smart Scale that tracks weight, BMI, lean mass and body fat percentage over time and wirelessly syncs to the Fitbit online or mobile dashboard to help users stay on track towards goals. Lastly, participants will also have access to FitStarTM by Fitbit premium software, which offers personalized video-based exercise experiences on mobile devices.
“It will be a challenge to help hundreds of women lose weight without actually ever meeting them face-to-face,” says Ligibel. “Fitbit products will allow coaches to see how participants are doing in terms of meeting their weight, physical activity and caloric goals, and step in when women need extra support to stay on track.”
Participants in the BWEL study will be randomized to a two-year weight loss intervention, plus either a health education program designed to provide information about breast cancer topics, or to a health education program-alone control group. Patients in the weight loss group will work with a health coach over the phone to help them increase their exercise and reduce calories. Fitbit Charge HR and the Aria Wi-Fi scale are being provided to help patients track progress throughout the study and help them to stay motivated to meet their goals. Coaches will receive the participant’s data with their explicit consent to see how they are doing, give encouragement and a little nudge when needed to help participants stay on track.

“We are thrilled to partner with Dana-Farber Cancer Institute on this type of intervention research, helping find a link between key behavioral changes and breast cancer recurrence and potentially helping reduce the terrible burden of cancer for millions of women and their families worldwide,” said Woody Scal, Chief Business Officer, Fitbit. “At Fitbit, we are focused on giving individuals the data, inspiration and guidance they need to help them reach their health and fitness goals. We hear stories every day about how our products help motivate people be more proactive with their health by being more active, eating smarter, sleeping better, and managing their weight – all of which are so important in preventive health.”

For more information on the study, visit https://clinicaltrials.gov/ct2/show/NCT02750826

Category: News and Trends, Past Articles

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