Obesity, Morbid Clinical Trial
Official title:
GLP-1 Therapy for Weight Loss and Improved Glucose Tolerance in Obese Children: A Randomized, Controlled, Pilot Study
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.
Status | Completed |
Enrollment | 12 |
Est. completion date | February 2011 |
Est. primary completion date | February 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 8 Years to 19 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Minnesota | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
University of Minnesota - Clinical and Translational Science Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Body Mass Index (BMI) | Change in body mass index (BMI) over three months | 3-month | No |
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