Exenatide in Extreme Pediatric Obesity
Condition: Obesity
MeSH terms: Obesity; Pediatric Obesity
Intervention: Exenatide; Placebo
Intervention description: Exenatide 5 micrograms (mcg) twice per day (BID) for one month; up-titrated to 10 mcg twice per day for remainder of study.; Participants were randomized to a placebo injection for the first three months, then given open-label Exenatide for the remaining three months (Initiated at 5 mcg, twice per day, delivered by subcutaneous injection. After 1 month, exenatide was uptitrated to 10 mcg, twice per day for the remaining 2 months of the drug treatment phase).
Intervention MeSH terms: Exenatide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 26.0
Sex: All
Minimum age: 12 Years
Maximum age: 19 Years
Healthy volunteers: No

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.
    

Eligibility 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)