Phase 2
N=12
GLP-1 Therapy for Weight Loss and Improved Glucose Tolerance in Obese Children
Obesity, Morbid
Bottom Line
View on ClinicalTrials.gov: NCT00886626 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Aug 2012
Primary outcome: Primary: Change in Body Mass Index (BMI) — -0.9; 0.84 change in kg/m^2
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Exenatide (Drug)
- Age
- Pediatric, Adult · 8+ yrs
- Sex
- All
- Sponsor
- University of Minnesota
- Primary completion
- Feb 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Body Mass Index (BMI) |
-0.9; 0.84 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00886626). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.