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NCT01237197 · ClinicalTrials.gov registry record · Phase 2
Exenatide in Extreme Pediatric Obesity
A Phase 2 study, sponsored by University of Minnesota.
- Completed
- Registry status
- Phase 2
- Development phase
- 26
- Enrollment target
NCT01237197 is a Phase 2 study that has completed, run by University of Minnesota. The registered enrollment target is 26 participants.
The verdict
NCT01237197, a Phase 2 study, has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 26 participants
- Enrollment target
Study Summary
Extreme pediatric obesity, the fastest growing category of obesity in youth, is associated with high risk for developing cardiovascular disease (CVD) and type 2 diabetes (T2DM). Obesity tracks strongly into adulthood and interventions early in life may reduce risk for developing cardiovascular disease and type 2 diabetes. Few drug therapies for weight loss have been evaluated in adolescents. Since exenatide is associated with weight loss and improves risk factors for cardiovascular disease and type 2 diabetes in adults, it may be useful in extremely obese youth. Our primary objective in this study is to generate preliminary data on the ability of exenatide to reduce body mass index (BMI) and improve risk factors for cardiovascular disease and type 2 diabetes in 26 extremely obese adolescents (age 12-19 years) in a three-month, randomized, double-blind, placebo-controlled pilot clinical trial. GLP-1 therapy has never been evaluated as a treatment for pediatric obesity and is an innovative approach to a challenging and significant health care problem.
Interventions
- DRUG Placebo
- DRUG Exenatide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2010-10 |
| Est. Completion | 2012-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01237197
The ClinicalTrials.gov registry entry for NCT01237197 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01237197 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01237197 about?
NCT01237197 is a clinical study titled "Exenatide in Extreme Pediatric Obesity". Extreme pediatric obesity, the fastest growing category of obesity in youth, is associated with high risk for developing cardiovascular disease (CVD) and type 2 diabetes (T2DM). Obesity tracks strongly into adulthood and interventions early in life may reduce risk for developing cardiovascular disea...
What is the current status of trial NCT01237197?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2010-10. Estimated completion is 2012-10.
What interventions are being tested in trial NCT01237197?
The interventions under investigation include: Placebo (DRUG), Exenatide (DRUG).
Who is sponsoring clinical trial NCT01237197?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
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