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.
For general information about weight control and physical activity
in children and teens, see: win.niddk.nih.gov/publications/child.htm
win.niddk.nih.gov/publications/take_charge.htm
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.
The National Institutes of Health (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. It is the primary federal agency for conducting
and supporting basic, clinical and translational medical research,
and it investigates 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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