After six months, people with intragastric balloons in their stomachs lost more than twice their excess weight, compared to people who tried to lose weight under a medically supervised diet and exercise program alone, according to new research from a randomized clinical trial presented here at ObesityWeek 2014, the largest international event focused on the basic science, clinical application and prevention and treatment of obesity.
In the 326-patient study, the combination of a dual-balloon implant (ReShape Duo® Integrated Dual Balloon System) and diet and exercise, helped those with a body mass index (BMI) of about 35, lose 28.5 percent of their excess weight, while those on a diet and exercise program alone, lost 11.3 percent. The study, “The REDUCE Pivotal Trial,” was presented as part of the “Top 10 Paper Session” at the 31st Annual Meeting of the American Society for Metabolic and Bariatric Surgery (ASMBS) during ObesityWeek 2014, which is hosted by the ASMBS and The Obesity Society (TOS).
“Novel treatments are needed to fill the treatment gap in obesity, particularly for those with lower BMIs, for whom bariatric surgery may not be an option,” said Jaime Ponce, MD, medical director for Hamilton Medical Center Bariatric Surgery program and principal investigator of the REDUCE Pivotal Trial. “ReShape Duo has the potential to fill this gap, given its effectiveness and favorable safety profile.”
In the dual intragastric balloon procedure, two uninflated balloons are inserted into the stomach through the mouth and esophagus via an endoscopic procedure, and then inflated with saline to reduce the capacity of the stomach, in turn making patients feel more full with less food. The balloon is removed after six months.
The REDUCE Pivotal Trial divided patients with obesity (BMI between 30 and 40 with one or more obesity-related comorbid conditions) into two groups. The treatment group received the balloon, while the control group had a “sham” or placebo endoscopic procedure. Patients in both groups were required to participate in diet and exercise counseling for the length of the study and for six months afterwards. In the balloon group, single balloon deflation occurred in 6 percent of patients without device migration and early retrieval for intolerance occurred in 15 percent. Gastric ulcers were noted at retrieval in 35 percent that were mostly small and superficial. A subsequent minor device modification reduced the ulcer rate to 10 percent.
ReShape Duo was developed by ReShape Medical, Inc., a Southern California medical device manufacturer, who earlier this year announced it submitted REDUCE Pivotal Trial data to the U.S. Food and Drug Administration (FDA) as part of its premarket approval (PMA) application. The device is currently limited to experimental use in the U.S. It has been available in Europe since 2011.
“The device shows promise and may prove to be a safe and effective supplement to diet and exercise for people with obesity,” said Ninh T. Nguyen, MD, ASMBS President and vice-chair of the UC Irvine Department of Surgery and chief of gastrointestinal surgery, who was not involved in the study. “The advantage of this device is its endoscopic method of implantation. However, the device can only be left in place for a limited period of time.”
In addition to Dr. Ponce, study investigators include George E. Woodman, MD, Baptist Memorial Hospital, TN; James M. Swain, MD, Scottsdale Healthcare System, AZ; Erik Wilson, MD, University of Texas Medical School in Houston; Eric Bour, MD, Greenville Hospital System, NC; Sayeed Ikramuddin, MD, University of Minnesota, MN; Wayne J. English, MD, Marquette General Hospital, MI; and Steven Edmundowicz, MD, Washington University, MO.
About Obesity and Metabolic and Bariatric Surgery
According to the Centers of Disease Control and Prevention (CDC), more than 78 million adults were obese in 2011-2012. The ASMBS estimates about 24 million people have severe obesity. Individuals with a BMI greater than 30 have a 50 to 100 percent increased risk of premature death compared to healthy weight individuals as well as an increased risk of developing more than 40 obesity-related diseases and conditions including type 2 diabetes, heart disease and cancer.
Metabolic/bariatric surgery has been shown to be the most effective and long lasting treatment for severe obesity and many related conditions and results in significant weight loss. The Agency for Healthcare Research and Quality (AHRQ) reported significant improvements in the safety of metabolic/bariatric surgery due in large part to improved laparoscopic techniques. The risk of death is about 0.1 percent and the overall likelihood of major complications is about 4 percent.
Story Source:
The above story is based on materials provided by American Society for Metabolic & Bariatric Surgery (ASMBS). Note: Materials may be edited for content and length.
Journal Reference:
- L Kaplan. Body Weight Regulation and Obesity. Journal of Gastrointestinal Surgery, 2003; 7 (4): 443 DOI: 10.1016/S1091-255X(03)00047-7