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Monday, April 16, 2007
NIH Launches Study to Assess Bariatric Surgery in Adolescents
The National Institutes of Health (NIH) today launched an observational study to evaluate the benefits and risks of bariatric surgery in adolescents. Bariatric surgery restricts stomach size and can decrease the amount of calories and nutrients the body absorbs. The Teen Longitudinal Assessment of Bariatric Surgery (LABS) study will help to determine if it is an appropriate treatment option for extremely overweight teens.
“The reasons for weight gain are complex and multifactorial, influenced by genetics, environment, eating and physical activity habits, and society. The information gathered from Teen-LABS will help determine if adolescence is the best time to intervene with this surgical therapy,” says Thomas Inge, M.D., Ph.D., chair, Teen-LABS and principal investigator for the center at Cincinnati Children’s Hospital Medical Center.
Overweight youth are more likely to develop serious health problems, such as type 2 diabetes and heart disease. Ideally, the goal for overweight adolescents and teens is to slow the rate of weight gain by eating fewer calories and being more physically active. However, these changes are tough to achieve and other approaches, such as drug therapy, are only approved for use in children 16 years and older.
“We know that bariatric surgery is not an easy way out for teens to control weight. They will still need to eat less food and exercise more,” says Mary Horlick, M.D., project scientist for Teen-LABS and director of the Pediatric Clinical Obesity Program of the Division of Digestive Diseases and Nutrition, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the sponsor of Teen-LABS at NIH. “We hope to learn whether or not bariatric surgery is suitable for teens and if it will help them remain at a healthy weight over the long-term.”
Recent statistics show that nearly 17 percent of youth ages 6-19 years old in the United States are considered overweight. Youth are defined as overweight if they have a body mass index (BMI) that is above the 95 percent for their sex and age. BMI measures weight in relation to height. There is no BMI cutpoint that defines obesity for children.
Over the next five years, researchers will enroll 200 adolescents who are scheduled for bariatric surgery and compare their data to 200 adults who had bariatric surgery after being obese since their teen years. The researchers will collect information on the pre-operative and two year post-operative status of the participants, including measures of body composition, body fat, cardiovascular risks, sleep apnea episodes, diabetes indicators, depressive symptoms, quality of life, eating habits, and nutritional status. The investigators will also store serum, plasma, urine and genetic samples for future studies.
Teen-LABS will not pay for the costs of bariatric surgery or patient care. Study participants must be able to support the cost of their surgery and related patient care through medical insurance or other means. Adolescents between 14 to 19 years are eligible for the study, but younger patients also could be considered if they meet current criteria.
Teen-LABS is based on the adult LABS study, which examines the benefits and risks of bariatric surgery and its impact on the health and well-being of adults with extreme obesity. Launched in 2003, the six clinical centers for the adult LABS have currently enrolled over 4000 patients in a series of short-term and longer-term studies. These studies seek to collect information on patient characteristics, types of surgeries, medical and psychosocial outcomes, economic factors, and other areas. The adult LABS study is expected to continue through 2008.
The Teen-LABS study is being conducted by researchers at the following medical centers:
- Cincinnati Children’s Hospital Medical Center (Data Coordinating Center and Clinical Center)
- Texas Children’s Hospital, Houston
- Children’s Hospital of Alabama in Birmingham
- University of Pittsburgh, Pennsylvania
For more information about Teen-LABS, email the central study coordinator, Rosie Miller, RN, CCRC at Rosemary.Miller@cchmc.org.
For more information about the adult LABS study, visit www.niddkLABS.org.
The NIDDK, a component of the NIH, conducts and supports research in diabetes and other endocrine and metabolic diseases; digestive diseases, nutrition, and obesity; and kidney, urologic and hematologic diseases. For more information about NIDDK and its programs, see www.niddk.nih.gov.
About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
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