Exenatide in Extreme Pediatric Obesity

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Extreme pediatric obesity, the fastest growing category of obesity in youth, is associated with high risk for developing cardiovascular disease (CVD) and type 2 diabetes (T2DM). Obesity tracks strongly into adulthood and interventions early in life may reduce risk for developing cardiovascular disease and type 2 diabetes. Few drug therapies for weight loss have been evaluated in adolescents. Since exenatide is associated with weight loss and improves risk factors for cardiovascular disease and type 2 diabetes in adults, it may be useful in extremely obese youth. Our primary objective in this study is to generate preliminary data on the ability of exenatide to reduce body mass index (BMI) and improve risk factors for cardiovascular disease and type 2 diabetes in 26 extremely obese adolescents (age 12-19 years) in a three-month, randomized, double-blind, placebo-controlled pilot clinical trial. GLP-1 therapy has never been evaluated as a treatment for pediatric obesity and is an innovative approach to a challenging and significant health care problem.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Minnesota; University of Minnesota - Clinical and Translational Science Institute
• Collaborator: Children's Hospitals and Clinics of Minnesota
• Treatments: Exenatide

Criteria

Inclusion Criteria:

• Body mass index > or = 1.2 times the 95th percentile (based on gender and age) or Body mass index > or = 35 kg/m2

• 12-19 years old

Exclusion Criteria:

• Type 1 or 2 diabetes mellitus

• Previous (within 3-months) or current use of weight loss medication (patients may undergo washout)

• Previous bariatric surgery

• Recent initiation (within 1-month) of anti-hypertensive or lipid medication

• Previous (within 1-month) or current use of medication to treat insulin resistance or hyperglycemia (patients may undergo washout)

• Major psychiatric disorder

• Pregnant or planning to become pregnant

• Tobacco use

• Liver/renal dysfunction

• History of pancreatitis

• Obesity associated with genetic disorder

• Hyperthyroidism or uncontrolled hypothyroidism

• Uncontrolled hypertriglyceridemia (=300 mg/dL)

• Current eating disorder

• Previous (within 3-months) or current use of drugs associated with weight gain (e.g. steroids/anti-psychotics)