At a glance
ClinicalIndex Comparison Record- ✓Age 12 to 17 years at study start
- ✓Obesity defined as BMI for age and triceps skinfold above 95th percentile (NHANES I standards) and body weight >60 kg
- ✓Evidence of quantifiable obesity-related comorbidity: hypertension, Type 2 diabetes, impaired glucose tolerance, hyperinsulinemia (fasting insulin >15 mIU/mL), hyperlipidemia (total cholesterol >200 mg/dL, LDL >129 mg/dL, or triglycerides >200 mg/dL), hepatic steatosis, or sleep apnea documented by sleep study
- ✓All four grandparents self-identified as either all Caucasian or all African American
- ✕Presence of renal, hepatic (except obesity-related steatosis), gastrointestinal, most endocrinologic (e.g., Cushing syndrome), or pulmonary disorders (except asthma not requiring continuous medication or sleep apnea-related disorders)
- ✕Pregnancy, currently nursing, or unprotected intercourse in adolescent girls
- ✕Current substance abuse or psychiatric disorder that would impede competence, compliance, or study completion
- ✕Regular use of prescription medications unrelated to obesity complications (except oral contraceptives used ≥2 months, or medications continued ≥3 months prior to entry)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety and Efficacy of Orlistat (Xenical, Hoffmann LaRoche) in African American and Caucasian Children and Adolescents With Obesity-Related Comorbid Conditions
In Brief
A Phase 2 clinical trial evaluating Orlistat and Placebo for Diabetes Mellitus and 4 related conditions. Completed, enrolled 200 participants across 1 site.
Detailed 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).
Study Details
Timeline
Interventions
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.