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News and Trends—May 2016

| May 1, 2016

No Decline in Obesity Rates among American Children, New Study Finds
Rates of severe obesity continue to present a serious public health threat, researchers say
Durham, North Carolina—The Duke Clinical Research Institute (DCRI) announced results from a study that finds no evidence of a decline in obesity prevalence in any age group, despite reports to the contrary. The results were published last month in Obesity.
The researchers examined data from the National Health and Nutrition Examination Survey (NHANES), which included all children aged 2–19 years who were included in the survey between 1999 and 2014. In the 2013–2014 sample, the researchers found that 33.4 percent of children met the criteria for being overweight, 17.4 percent for class I obesity, 6.2 percent for class II obesity, and 2.4 percent for class III obesity. The team also detected a statistically significant increase in all classes of obesity from 1999 through 2014. There was no indication of a decline in recent years.
“Despite some other recent reports, we found no indication of a decline in obesity prevalence in the United States in any group of children aged 2 through 19,” said lead author Asheley Skinner, PhD, of the DCRI. “This is particularly true with severe obesity, which remains high, especially among adolescents.”
Obesity has increased among all age groups in the United States over the last 30 years. Recent reports of possible declines have not examined severe obesity in a nationally-representative population, focusing instead on low-income young children, or children from defined geographic areas. Other studies of national obesity rates have shown no changes in the prevalence of overweight or obesity, but most have not examined severe obesity.
“This study uses national data to identify alarming trends in childhood obesity,” said DCRI Executive Director Eric Peterson, MD, MPH.  “With the insights gleaned, we can address a childhood issue that if not addressed will translate downstream into epidemics of diabetes, cardiovascular disease, and other illnesses associated with obesity.”
Weight status was defined using measured height and weight and standard definitions as follows: overweight as ≥85th percentile for age- and sex-specific body mass index (BMI); class I obesity as ≥95th percentile; class II obesity as ≥120 of the 95th percentile, or BMI ≥ 35; and class III obesity as ≥140% of the 95th percentile, or BMI ≥ 40.
The NHANES is a program of studies designed to assess the health and nutritional status of adults and children in the United States. The program is administered by the National Center for Health Statistics, part of the Centers for Disease Control and Prevention.
In addition to Skinner, study authors include Eliana Perrin, MD, MPH, of UNC-Chapel Hill and Joseph Skelton, MD, MS, of Wake Forest University.
About the Duke Clinical Research Institute. The DCRI is the largest academic research organization in the world, with a mission to develop and share knowledge that improves the care of patients through innovative clinical research. The DCRI conducts groundbreaking multinational clinical trials, manages major national patient registries, and performs landmark outcomes research. DCRI research spans multiple disciplines, from pediatrics to geriatrics, primary care to subspecialty medicine, and genomics to proteomics. The DCRI also is home to the Duke Databank for Cardiovascular Diseases, the largest and oldest institutional cardiovascular database in the world, which continues to inform clinical decision-making 40 years after its founding.

UC San Diego Launches New Nonalcoholic Fatty Liver Disease Research Center
Roughly one-quarter of all Americans—an estimated 100 million adults and children—have nonalcoholic fatty liver disease (NAFLD), a chronic condition that can lead to cirrhosis, liver cancer and liver failure. Combining a diverse array of basic science, biomarkers, imaging and clinical efforts, University of California, San Diego School of Medicine has launched a new NAFLD Research Center to better understand the disease and develop treatments where none currently exist.
“We already have a lot of depth and breadth in the study and treatment of NAFLD and associated conditions at UC San Diego,” said Rohit Loomba, MD, professor of medicine in the Division of Gastroenterology and director of the new center. “In pharmacology, molecular medicine, physician training, clinical trial design and drug development, scientists and researchers here have been working on NALFD and related diseases for a long time. But this is a major step. It creates a single entity able to address every aspect of a global disease that didn’t even exist 35 years ago.”
NAFLD occurs when fat accumulates in liver cells due to causes other than excessive alcohol use. The precise cause is not known, but diet and genetics play substantial roles. Up to 50 percent of obese people are believed to have NAFLD. The condition is particularly prevalent among Hispanics and Asians.
NAFLD can progress to nonalcoholic steatohepatitis (NASH), a more extreme form of the disease, which can, in turn, result in cirrhosis or liver cancer. In most cases, adverse effects are not noticeable until the disease is well-advanced. NAFLD is closely linked to diabetes.
“In 2000, just 2 percent of liver transplants were caused by the eventual effects of NAFLD,” said Loomba. “In 2011, it was the third leading indicator for transplant and may soon be the leading indication for liver transplant.”
Loomba said the new center would accelerate efforts to develop non-invasive biomarkers for early diagnosis of NASH as well as treatments for NAFLD and NASH. Currently, there are no approved, specific therapies. “The goal of our research program is to prevent the progression of NAFLD to cirrhosis, and find better ways to treat the condition,” Loomba said.
To that end, researchers at UC San Diego have already made progress, developing a diagnostic tool using magnetic resonance imaging that avoids the current requirement of a liver biopsy for assessment of treatment response in early phase clinical trials. “This is a key advance because it means you can conduct clinical trials with a tool that is effective but non-invasive and get an early signal of efficacy.”
UC San Diego researchers and colleagues elsewhere are also investigating the use of low-cost ultrasound diagnostics and biomarkers based upon metabolomics—the chemical fingerprints left by specific cellular processes—and microbiomics, specifically analyses of stool samples to predict NASH and hepatic fibrosis, the accumulation of scar tissue resulting from chronic liver disease.
Loomba and colleagues have also designed and conducted several ground-breaking clinical trials for NAFLD and NASH. The creation of the center provides a one-stop shop for all areas of investigation in NASH. The newly created NAFLD research center, said Loomba, would attract collaborations with biotechnology industry as well as to pharmaceutical companies that have a biomarker development program or are looking for expertise in innovative clinical trial design.
“This center will act as an epicenter for NASH clinical drug development and as a catalyst in biomarker discovery, validation and their application in clinical practice,” said David Brenner, MD, vice chancellor for health sciences, dean of the School of Medicine and professor of medicine in the Division of Gastroenterology.
The NAFLD Research Center brings together multiple specialties and specialists at UC San Diego School of Medicine and elsewhere.
For more information, visit the NAFLD Research Center at http://gastro.ucsd.edu/fatty-liver/Pages/default.aspx.

Non-alcoholic Fatty Liver Disease Ups Heart Disease, Mortality Risk
PARIS, France (Health Newsline)—Non-alcoholic fatty liver disease (NAFLD), one of the causes of fatty liver, may accelerate risk of cardiovascular disease, warns a new research by French researchers.
The research from the Pitie-Salpetriere Hospital, Pierre and Marie Curie University in Paris has found that NAFLD not only increases heart disease risk but also the mortality rates associated with it.
If the research findings are to be believed, nonalcoholic fatty liver disease is an independent risk factor for atherosclerosis, a medical condition in which plaque builds up inside the arteries and usually causes heart attacks, strokes, and peripheral vascular disease, collectively called cardiovascular disease (CVD).
“Evidence indicates that the fatty and inflamed liver expresses several pro-inflammatory and procoagulant factors, as well as genes involved in accelerated atherogenesis,” explained lead investigator Raluca Pais, MD, of the Pierre and Marie Curie University in Paris, France.
Senior author Vlad Ratziu, Professor of Medicine at the Pierre and Marie Curie University, added, “This raises the possibility that the link between NAFLD and cardiovascular mortality might not simply be mediated by shared, underlying, common risk factors, but rather that NAFLD independently contributes to increasing this risk.”
For the study, Pais and colleagues analysed a large retrospective study of 5,671 patients without a history of CVD but with at least two risk factors. The participating patients, with mean age 52, were referred to the Primary Cardiovascular Prevention Center at Pitie-Salpetriere Hospital, Paris between 1995 and 2012. Nearly half of the participants were women, and one third of the patients had steatosis as defined by the fatty liver index (FLI), a validated surrogate marker.
The team assessed whether NAFLD is associated with or is the driving force behind atherosclerosis of the carotid arteries, the major blood vessels in the neck that transport blood to the brain, neck, and face.
After assessing the data, the team found that in patients with metabolic syndrome at risk for cardiovascular events, NAFLD leads to thickness in the major blood vessels in the neck, independent of traditional cardiovascular risk factors such as diabetes, heart disease or stroke.
Fatty liver disease at baseline predicted the occurrence of carotid plaques even after taking other risk factors like age, sex, diabetes, smoking, and hypertension into account.
Based on their findings, the researchers suggested strict monitoring of cardiovascular disease should be considered when managing nonalcoholic fatty liver disease.
“Clinicians should be aware of the increased cardiovascular risk in patients with NAFLD and consequently screen for conventional cardiovascular risk factors and use accepted risk calculators to make decisions regarding preventative pharmacotherapy, including statins,” commented experts Leon Adams of the University of Western Australia and Quentin M. Anstee of Newcastle University, UK, in an accompanying editorial.
The findings are reported in a paper published in the Journal of Hepatology.

Study examines surgical skill and weight loss surgery success
Operating skills impact early complications but not long-term outcomes
ANN ARBOR, Michigan—Poor surgical skills during bariatric surgery have a quick impact on patients, landing some in emergency departments for bleeding and infection once the operation is over.
But a surgeons’ operating skills did not affect patients’ wellness or weight loss a year later, according to a study in JAMA Surgery.
Senior author Justin B. Dimick, MD, MPH, professor of surgery at the University of Michigan Health System, and Christopher P. Scally, MD, a general surgery resident at the U-M, worked with colleagues to assess the relationship between video reviews of surgeons’ operating skills and the health status of 3,631 patients one year after having common, but complex laparoscopic gastric bypass surgery.
Peer ratings of surgical skill varied from 2.6 to 4.8 on the 5-point scale.
In contrast to its effect on early complications, surgical skill did not affect post-operative weight loss or resolution of medical conditions at one year.
There was no difference between the best (top 25 percent) and worst (bottom 25 percent) performance groups when comparing excess body weight loss—67 percent vs. 68.5 percent.
Weight loss is the main criteria for bariatric surgery, but not the only one. Bariatric surgery has proven to resolve other diseases and conditions caused by being overweight or obese.
The JAMA Surgery study showed just as many patients saw dramatic improvement of sleep apnea, hypertension and high cholesterol whether they had a surgeon in the high-skill group or low-skill group.
There was no difference in resolution of hypertension (47 percent vs. 45 percent) between highly rated surgeons and those with low skill scores.
Surgeons with the lowest skill rating had patients with higher diabetes resolution (79 percent) when compared with the highest skill surgeons (73 percent).
Video ratings and outcomes. Based on viewing a single video that surgeons submitted themselves, surgeons were rated on a scale of 1 to 5, with 1 indicating the skill of a doctor in training and 5 indicating the skill of a master surgeon.
Participation was voluntary and various skills such as gentleness, time and motion, instrument handling, flow of operation, tissue exposure and overall technical skill were rated anonymously.
In a previous study, surgeons who received low-skill scores had surgical complications nearly three times higher than high-skill surgeons.
“Although surgical skill may influence short-term complication rates and patient satisfaction ratings, the findings suggest that long-term outcomes after bariatric surgery may be more dependent on other factors not yet measured among patients, hospitals or surgeons,” authors write.
“Future studies should take advantage of video analysis by measuring both operative technique and surgical skill as a means of understanding a surgeon’s effect on surgical quality,” according to the study.

The American Board of Obesity Medicine welcomes new Medical Director Dr. Lisa DeRosimo
The American Board of Obesity Medicine is pleased to welcome Dr. Lisa DeRosimo as the organization’s first medical director. In this part-time position, Dr. DeRosimo will serve as an obesity medicine clinical content expert interacting with ABOM administrative staff, board of directors, item writing committee members, diplomates and physician candidates.
“We are thrilled to welcome Dr. DeRosimo to the ABOM team,” said Executive Director Dana Brittan. “With the rapid growth of the field of obesity medicine, it became apparent that ABOM would be well served by adding a physician to the staff. With a lengthy background as a practicing obesity medicine physician, Dr. DeRosimo brings a wealth of experience to this new role.”
Lisa DeRosimo MD, MS, has concentrated her career on the study and treatment of obesity since 1989. She obtained a degree in Psychobiology from UCLA as well as a master’s degree in Human Nutrition from Cornell University. She participated in peer-reviewed research on obesity at both institutions. Dr. DeRosimo completed her education at the University of Pittsburgh School of Medicine, in order to understand obesity from the clinical perspective. She served on the American Board of Bariatric Medicine as Chair, until the board became the American Board of Obesity Medicine. She currently works as an obesity medicine physician at Baptist Health Medical Group in Miami, Florida.
“It is an honor and a privilege to continue to serve the field of obesity medicine as the medical director for ABOM,” said DeRosimo. “It has already been an exciting experience to be part of the growth and change that has taken place within obesity medicine over the last few years. I am so grateful to now have the opportunity to work with the board of directors as we continue to expand, recruit and certify physicians in this important field of medicine.”

Obesity Action Coalition(OAC) Calls On TNT To Suspend Charles Barkley for Stigmatizing Comments Toward Individuals Affected by the Disease of Obesity
Tampa, Florida—The Obesity Action Coalition (OAC), a more than 52,000 member-strong organization, is calling on TNT to suspend Charles Barkley for his latest weight bias-fueled comments made during a recent Inside the NBA broadcast on TNT.
“Unfortunately, Mr. Barkley has once again taken the low road and targeted women in San Antonio for their weight and size. In 2015, the OAC spoke out publicly against Mr. Barkley’s biased comments, and once again, he’s unfairly targeted individuals dealing with obesity,” said Joe Nadglowski, OAC President and CEO.
The OAC maintains a strong stance on weight bias in that individuals affected by obesity frequently struggle with not only the health and physical consequences of their disease, but also with other social consequences. The OAC strongly believes that no person should be discriminated against based on their size or weight.
As a former NBA player and sports personality, Mr. Barkley should encourage equality and respect among society and not look to segment one population because of their size. Obesity is a serious medical condition impacting more than 72 million U.S. adults nationwide.
“My question to Mr. Barkley would be, ‘What value does targeting this population bring to your abilities as an NBA analyst? Why do you continue to stigmatize individuals with obesity?’ There is simply no value to his comments, and they need to stop—now,” said Amber Huett-Garcia, MPA, OAC Chairwoman.
Mr. Barkley repeatedly offends individuals with obesity, and yet, TNT and the NBA fail to see the problem with this. At this time, the OAC is calling on all members and the public to contact TNT leadership and encourage the suspension of Mr. Barkley. The OAC has also contacted the Commissioner of the NBA, Adam Silver, to encourage Mr. Barkley to immediately apologize for his comments.
To learn more about this issue and contact TNT leadership and the NBA Commissioner, please visit http://bit.ly/1ObAbE6.
The Obesity Action Coalition (OAC), a more than 52,000 member-strong National non-profit organization, is dedicated to improving the lives of individuals affected by the disease of obesity through education, advocacy and support.

Final Stampede Results: Glycemic Benefits of Bariatric Surgery Persist Over Time
Glycemic control, weight loss endure out to five years
CHICAGO, Illinois—In the final, five-year follow-up report from the influential STAMPEDE (Surgical Therapy And Medications Potentially Eradicate Diabetes Efficiently) trial, Cleveland Clinic research shows that bariatric surgery’s beneficial effects on blood glucose control in mild and moderately obese patients with type 2 diabetes may persist for up to five years, with the advantage over diabetes medications-only approach widening over time.
The five-year follow-up also reported that:
•    Over 88 percent of gastric bypass and sleeve gastrectomy patients maintained healthy blood glucose levels without the use of insulin.
•    29 percent of gastric bypass patients and 23 percent of sleeve gastrectomy patients achieved and maintained normal blood glucose levels, compared to just 5 percent of those on medication alone.
•    Weight loss was significantly greater with gastric bypass and sleeve gastrectomy than with medications and was the primary driver for glucose control.
•    The effects of both surgical procedures to normalize glucose levels did however diminish overtime and some late complications were noted with surgery.

“Our findings show continued durability of glycemic control after metabolic surgery, as well as persistent weight loss, reduction in diabetes and cardiovascular medications at five years,” said Philip Schauer, MD, lead author and Cleveland Clinic bariatric surgeon, who presented the results at ACC.16, the American College of Cardiology’s 65th Annual Scientific Session.
“The superior benefits of surgery to attain diabetes treatment goals must be carefully balanced with the long-term risks associated with surgery for individual patients,” said Sangeeta Kashyap, MD, co-investigator involved with the trial and an endocrinologist at Cleveland Clinic’s Endocrinology & Metabolism Institute.
According to the CDC, 29 million people in the United States (9.3 percent) have diabetes. More than 70,000 persons die annually due to complications associated with diabetes, according to the American Diabetes Association. Approximately 50 percent of patients currently treated for type 2 diabetes with medications are not meeting standard targets of glycemic control and thus are at risk for developing complications of diabetes.
“Left unchecked, diabetes can lead to kidney failure, blindness, and limb amputation,” said Dr. Kashyap. “At the five-year mark, bariatric surgery’s metabolic effect persists and is more effective at treating type 2 diabetes in moderate and severely obese patients when compared to medical therapy.”
The STAMPEDE  trial is the largest randomized trial with one of the longest follow-ups comparing medical therapy with bariatric surgery.
The trial initially involved 150 overweight patients with poorly controlled diabetes. The patients were divided into three groups: 1) Fifty patients received intensive medical therapy only, including counseling and medications; 2) Fifty patients underwent Roux-en-Y gastric bypass surgery and received medical therapy; 3) Fifty patients underwent sleeve gastrectomy and received medical therapy.
Effectiveness was gauged by the percentage of patients who achieved blood sugar control, defined in this study as hemoglobin HbA1c level of less than or equal to 6.0 percent—a more aggressive target than the American Diabetes Association’s guidelines. HbA1c is a standard laboratory test that reflects average blood sugar over three months.

Findings from the five-year follow-up confirm those from the one-year and three-year reports and include the following:
•    Rates of achieving and maintaining an HbA1c level of 6.0 percent or less at five years were significantly higher with gastric bypass (29 percent) and sleeve gastrectomy (23 percent) than with intensive medical therapy alone (5 percent).
•    Weight loss was significantly greater with gastric bypass and sleeve gastrectomy than with medical therapy.
•    Use of cardiovascular and glucose-lowering medications, including insulin, at five years was significantly reduced from baseline in both surgical groups, and was significantly lower in the surgical groups than in the medical therapy group. Over 88 percent of surgically treated patients maintained glycemic control without use of insulin.

The five-year analysis also yielded several new insights, including the following:
•    In the two surgical groups, achieving the primary end point of an HBA1c less than or equal to ≤ 6.0 percent was predicted both by a reduction in body mass index (BMI) and a duration of diabetes of less than eight years.
•    There were no late major complications of surgery except for one reoperation (a successful laparoscopic conversion of sleeve gastrectomy to gastric bypass for recurrent gastric fistula) four years after randomization.
•    Significant and durable improvements in bodily pain and general health were demonstrated using a validated quality-of-life instrument in both surgical groups relative to the medical group.
•    Several biomarkers associated with heightened cardiovascular risk were reduced in the surgical arms, but there were no beneficial effects on retinopathy or nephropathy seen at 5 years.
“Some advantages of gastric bypass over sleeve gastrectomy have emerged during follow-up,” Dr. Schauer said. “At five years, gastric bypass maintained greater weight loss than sleeve gastrecomy while requiring fewer medications.”
He also notes that the final STAMPEDE results might help expand the population of patients in whom bariatric surgery may be considered for improving glycemic control.
“Most clinical guidelines and insurance policies for bariatric surgery limit access to patients with a BMI of 35 or above,” Dr. Schauer added. “Our five-year results demonstrate that glycemic improvement in patients with a BMI of 27 to 34 is durable at least up to five years.”
More information on the STAMPEDE clinical trial can be found at clevelandclinic.org/weightloss

Category: News and Trends, Past Articles

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