Status:
COMPLETED
GLP-1 Therapy for Weight Loss and Improved Glucose Tolerance in Obese Children
Lead Sponsor:
University of Minnesota
Conditions:
Obesity, Morbid
Eligibility:
All Genders
8-19 years
Phase:
PHASE2
Brief 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 ...
Detailed Description
This will be a randomized, open-label, controlled, crossover clinical trial in 12 patients. All patients will receive exenatide and undergo the control phase. Following baseline testing, participants ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00886626
Start Date
May 1 2009
End Date
February 1 2011
Last Update
October 29 2012
Active Locations (1)
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1
University of Minnesota
Minneapolis, Minnesota, United States, 55455