Status:
COMPLETED
Exenatide in Extreme Pediatric Obesity
Lead Sponsor:
University of Minnesota
Collaborating Sponsors:
Children's Hospitals and Clinics of Minnesota
Conditions:
Obesity
Eligibility:
All Genders
12-19 years
Phase:
PHASE2
Brief 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 strongl...
Detailed Description
26 (approximately 13 per site) extremely obese (Body mass index \[BMI\] \> or = 1.2 times the 95th percentile or BMI \> or = 35 kg/m2) adolescents (age 12-19 years old) will be enrolled in a six-month...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01237197
Start Date
October 1 2010
End Date
October 1 2012
Last Update
September 12 2014
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Minnesota
Minneapolis, Minnesota, United States, 55455
2
Children's Hospitals and Clinics of Minnesota
Saint Paul, Minnesota, United States, 55102