GLP-1 Therapy for Weight Loss and Improved Glucose Tolerance in Obese Children
Completed · Phase 2
Conditions studied: Obesity, Morbid
In brief
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.
Key facts
- Study ID
- NCT00886626
- Run by
- University of Minnesota
- People needed
- 12
- Starts
- 2009-05-01
- Expected to finish
- 2011-02-01
- Last updated by the study team
- 2012-10-29
Who can join
Age: 8 and older, up to 19. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- University of Minnesota — Minneapolis, Minnesota, United States
Full record on ClinicalTrials.gov
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