Primary outcome
What NCT00886626 measured first
| Exenatiden=11 | Controln=11 |
|---|---|
| -0.9(1.2) | 0.84(1.3) |
Phase 2 · Exenatide
NCT00886626 trial results
GLP-1 Therapy for Weight Loss and Improved Glucose Tolerance in Obese Children: A Randomized, Controlled, Pilot Study
Change in Body Mass Index (BMI) (change in kg/m^2), 3-month. Exenatide: -0.9; Control: 0.84.
- Participants
- 12
- Status
- completed
- Completed
- 2011-02
- Sponsor
- University of Minnesota
As posted on ClinicalTrials.gov (NCT00886626), updated at source Oct 29, 2012. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.
Side effects by arm
Side effects in NCT00886626
Percent of participants affected, 6-month. The most common events the registry lists.
| Event | Exenatide | Control |
|---|---|---|
| Any serious event | 0% | 0% |
| Nausea | 36.4% | 0% |
The trial
How NCT00886626 was run
The prevalence of severely obese children is on the rise. Behavioral therapies for weight loss are successful in some, but others need more aggressive approaches such as drug therapy. In addition, up to 25% of severely obese children have impaired glucose tolerance (IGT), which places them at significantly elevated risk of developing type 2 diabetes mellitus and cardiovascular disease. Although various drug therapies for weight loss and IGT have been explored in adults, few have been evaluated in children. Recently, a new drug class has emerged that targets deficiencies of GLP-1. One of the main glycemic mechanisms of action of the GLP-1 agonists such as exenatide is to enhance glucose disposal in the postprandial setting and improve glucose tolerance. In addition, exenatide can induce weight loss by decreasing appetite and slowing gastric motility.
- Exenatide: Exenatide
- Control: Control - no intervention
Who could join the trial
Inclusion Criteria: * Age 8-19 years old * Subject able to give assent, and parent/guardian capable of giving consent on behalf of the child * Body mass index (BMI) ≥ 99th percentile (based on gender and age) Exclusion Criteria: * Type 1 or 2 diabetes mellitus * Initiation of a new drug therapy within the past 30 days prior to the screening visit * BMI ≥ 55 * History of weight loss surgery * Obesity from a genetic cause (e.g., Prader-Willi) * Central nervous system injury or severe neurological impairment * Known systolic or diastolic dysfunction or heart failure * Females who are currently pregnant or planning to become pregnant * Liver enzymes \> 2.5 times upper limit of normal * Severe renal impairment (defined as creatinine clearance \<30 mL/min) * Gastrointestinal disease
Published papers
Papers from NCT00886626
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.
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