Exenatide in Extreme Pediatric Obesity
Condition: Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      26 (approximately 13 per site) extremely obese (Body mass index [BMI] > or = 1.2 times the
      95th percentile or BMI > or = 35 kg/m2) adolescents (age 12-19 years old) will be enrolled in
      a six-month study consisting of a three-month, randomized, double-blind (participants and
      investigators), placebo-controlled pilot clinical trial phase followed by a three-month
      open-label extension during which all participants will receive exenatide. For the initial
      three-month phase, participants will be equally (by site) and randomly assigned to one of two
      groups: 1) exenatide plus lifestyle modification, or 2) placebo plus lifestyle modification.
      Following baseline testing, subjects will be randomly assigned to study group. Participants
      will return at one-month for titration and assessment of safety (blood draw and adverse event
      assessment) and injection/lifestyle modification compliance and at three-months for
      reassessment of baseline variables and injection/lifestyle modification compliance and
      allocation to study drug for the three-month open-label extension. Participants will return
      at four-months for assessment of safety (blood draw and adverse event assessment) and
      injection/lifestyle modification compliance and at six-months for reassessment of baseline
      variables and injection/lifestyle modification compliance.

      All subjects, regardless of group assignment, will participate in the clinical lifestyle
      modification program offered through either the University of Minnesota or Children's
      Hospitals and Clinics weight management programs. Participants and their families receive
      regular (approximately bi-monthly) face-to-face and/or phone behavioral-, dietary-, and
      physical activity-counseling from a multi-disciplinary team of health care professionals
      including physicians, dieticians, registered nurses, psychologists, and exercise
      physiologists.

      Screening will include review of medical records for previous clinical and laboratory data.
      The following measures will be collected at baseline, 3 months, and 6 months. Subject will be
      asked to fast for a minimum of 12 hours.
    

Intervention name(s): Exenatide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 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).
Other intervention name(s): Byetta; Sugar pill
Intervention MeSH terms: Exenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment