Safety and Efficacy of Xenical in Children and Adolescents With Obesity-Related Diseases
Condition: Diabetes Mellitus; Hypertension; Metabolic Disease; Obesity; Sleep Apnea Syndrome
MeSH terms: Sleep Apnea Syndromes; Obesity; Metabolic Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      Obesity is a condition affecting one-third off the U.S. population and is a major risk actor
      for the development of Type 2 diabetes, hyperlipidemia (increased levels of fat in the
      blood), hypertension (high blood pressure), and other disorders of the heart and lungs.
      Individuals with the onset of obesity during childhood or adolescence are at an increased
      risk of obesity-related, diseases, both during adolescence and later in adult life.

      African American girls and women are at an increased risk for obesity, and have substantial
      rates of obesity-related diseases and causes of death. Further, many African American adult
      women fail to respond to many of the therapeutic approaches used to treat obesity. At present
      there are no medical therapies proven effective for the correction of severe obesity in
      children or adolescents.

      One medication that may have a favorable risk-benefit ratio in pediatric populations is
      Orlistat (Xenical, Hoffmann LaRoche). Orlistat works by preventing the action of enzymes in
      the digestive process, interfering with the absorption of approximately 1/3 of the fat eaten
      in the diet. Xenical appears to be effective for reducing weight and obesity-associated
      diseases in obese adults.

      Researchers propose to determine the safety, tolerability, and efficacy of Xenical in 12-17
      year old severely obese African American and Caucasian children and adolescents who have one
      or more obesity-related disease (hypertension, hyperlipidemia, sleep apnea, hepatic
      steatosis, insulin resistance, impaired glucose tolerance, or Type 2 diabetes).
    

Detailed description: 
      Obesity is a condition affecting one-third of the adult U.S. population and is a major risk
      factor for the development of Type 2 diabetes, hyperlipidemia, hypertension, and other
      cardiovascular and respiratory disorders. Individuals with the onset of obesity during
      childhood or adolescence are at increased risk for obesity-related, comorbid conditions, both
      during adolescence and later in life. African American girls and women are at particular risk
      for obesity, and have substantial rates of obesity-related morbidity and mortality. Further,
      African American adult women have a less satisfactory response to many therapeutic approaches
      used to treat obesity. At present, there are no medical therapies proven effective for the
      amelioration of severe obesity in children or adolescents. One medication that may have a
      favorable risk-benefit ratio in pediatric populations is orlistat (Xenical(Trademark),
      Hoffmann LaRoche). Orlistat acts by inhibiting gastrointestinal lipases, interfering with the
      absorption of approximately 1/3 of ingested dietary fat. 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.
    

Intervention name(s): Orlistat; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months.; Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months.
Other intervention name(s): Xenical (orlistat)capsules; Placebo capsule
Intervention MeSH terms: Orlistat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dyslipidemia; Race; Body Fat; Visceral Fat; Sleep Apnea; Fat-Soluble Vitamins; Type 2 Diabetes; Obesity; Childhood Obesity