Active Ingredient: Orlistat
Age 12-17 years at study entry. Body mass index BMI for age above the 5 th percentile and below 85 th percentile, which is considered normal weight by CDC growth chart standards.
For females with childbearing potential, a negative pregnancy test at initial evaluation. Please refer to this study by its ClinicalTrials. Eating a low-fat diet will reduce the likelihood of this side effect.
Also, patients who have had an organ transplant should not take OTC orlistat because of possible drug interactions. At present, there are no medical therapies proven effective for the amelioration of severe obesity in children or adolescents.
Orlistat appears to be effective for reducing weight and obesity-associated comorbidities in obese adults. We propose to determine the safety, tolerability, and efficacy of orlistat in 12-17 year-old severely obese African American and Caucasian children and adolescents who have one or more obesity-related comorbidity hypertension, hyperlipidemia, sleep apnea, hepatic steatosis, insulin-resistance, impaired glucose tolerance, or Type 2 diabetes.
Under this protocol, we have conducted an open-label pilot study of orlistat in twenty subjects, suggesting orlistat has a similar side effect profile in adolescents as in adults. We wish to determine the safety and efficacy of orlistat in reducing obesity-related comorbidities using a randomized, double-blind, placebo-controlled clinical trial.
All study participants will be enrolled in a psycho-educational weight loss program that includes nutrition education, cognitive-behavioral self-monitoring strategies, and promotion of physical activity. We will also study the effects of orlistat on fat preferences, and study the influence of genetic variables on energy expenditure and weight loss during treatment.
A group of healthy, non-overweight children and adolescents will complete questionnaires and exercise studies as a control group for interpretation of results in overweight children and adolescents, but will not undergo phlebotomy or receive any medication.
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