Primary outcome
What NCT01237197 measured first
| Exenatiden=12 | Placebo Injectionn=10 |
|---|---|
| -2.9(1.8) | -0.15(3.2) |
Phase 2 · Exenatide
NCT01237197 trial results
Exenatide in Extreme Pediatric Obesity
Percent Change From Baseline in Body Mass Index at 3-months (percentage of change in BMI), Baseline and 3-months. Exenatide: -2.9; Placebo Injection: -0.15.
- Participants
- 26
- Status
- completed
- Completed
- 2012-10
- Sponsor
- University of Minnesota
As posted on ClinicalTrials.gov (NCT01237197), updated at source Sep 12, 2014. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.
Side effects by arm
Side effects in NCT01237197
Percent of participants affected. The most common events the registry lists.
| Event | Exenatide | Placebo Injection |
|---|---|---|
| Any serious event | 0% | 0% |
| Nausea | 61.5% | 30.8% |
| Headache | 23.1% | 46.2% |
| Vomiting | 30.8% | 7.7% |
| Diarrhea | 7.7% | 30.8% |
The trial
How NCT01237197 was run
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.
- Exenatide, then Open-Label Exenatide: Exenatide 5 micrograms (mcg): administered with injection twice per day (BID) for one month; up-titrated to 10 mcg twice per day for remainder of study (5 months)
- Placebo, then Open Label Exenatide: Placebo injection twice a day for three months; Exenatide open label 5mcg twice a day for one month and up-titrated to 10mcg twice a day for remaining two months of study.
Who could join the trial
Inclusion Criteria: * Body mass index \> or = 1.2 times the 95th percentile (based on gender and age) or Body mass index \> or = 35 kg/m2 * 12-19 years old Exclusion Criteria: * Type 1 or 2 diabetes mellitus * Previous (within 3-months) or current use of weight loss medication (patients may undergo washout) * Previous bariatric surgery * Recent initiation (within 1-month) of anti-hypertensive or lipid medication * Previous (within 1-month) or current use of medication to treat insulin resistance or hyperglycemia (patients may undergo washout) * Major psychiatric disorder * Pregnant or planning to become pregnant * Tobacco use * Liver/renal dysfunction * History of pancreatitis * Obesity associated with genetic disorder * Hyperthyroidism or uncontrolled hypothyroidism * Uncontrolled hypertriglyceridemia (=300 mg/dL) * Current eating disorder * Previous (within 3-months) or current use of drugs associated with weight gain (e.g. steroids/anti-psychotics)
Published papers
Papers from NCT01237197
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.
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