Status:
WITHDRAWN
The Effects of Exenatide on Post-Meal Sugar Peaks and Vascular Health in Obese/Pre-Diabetic Young Adults
Lead Sponsor:
Yale University
Collaborating Sponsors:
Amylin Pharmaceuticals, LLC.
Conditions:
Obesity
Insulin Resistance
Eligibility:
All Genders
13-25 years
Phase:
PHASE4
Brief Summary
The primary aim of this study is to evaluate the effect of exenatide on daily glycemic excursions obtained by continuous glucose monitoring system (CGMS). The CGMS summary parameters that we are most ...
Detailed Description
Obese insulin resistant adolescents with impaired glucose tolerance (IGT) or evidence of glucose excursions ≥ 140 mg/dl on CGMS will be enrolled in a two armed randomized, parallel group - open label ...
Eligibility Criteria
Inclusion
- Obese subjects:
- Major
- Obesity (BMI \> 97%tile for age and sex matched normative data)
- Insulin resistance: fasting insulin\> 25 mIU/ml
- Good general health, taking no medication on a chronic basis
- Age 16-25 yrs, late pubertal stage (girls: breast: Tanner stage IV to V, boys: testicular volume \> 15 ml) or age 13-15 yrs (with a family history of type 2 diabetes, whom have completed or reached tanner stage III and have impaired oral glucose tolerance with a 2-hour glucose of 180-199 mg/dl)
- Girls who are sexually active must use adequate birth control methods (such as barrier method or oral contraception) and must have a negative pregnancy test
- Normal liver function tests
- Major
Exclusion
- Hx of gallstones
- Elevated triglycerides \>400 mg/dl
- Hx of alcohol use/ binge drinking
- Raynaud's syndrome
- Pregnancy or breastfeeding mothers
- Cigarette smokers
- Anemia (Hct \< 35)
- Baseline creatinine \> 1.0 mg
- Abnormal liver transaminases \> 2.0 X the upper limit of normal
- Presence of endocrinopathies except for adequately treated hypothyroidism
- Presence or history of gastrointestinal disorders (inflammatory bowl disease, irritable bowl disease, hernia, ileus)
- Presence of significant chronic illness of any kind.
- Use of any drugs that might be expected to affect glucose tolerance, insulin resistance or weight gain, cardiovascular health.
- Psychiatric disorders
- History of substance abuse
- Lean Control Subjects (only for cardiovascular studies and CGMS):
- Inclusion Criteria:
- Lean (BMI \< 85%tile for age and sex matched normative data)
- Fasting insulin \<15 mIU/m
- Fasting glucose \<100 mg/dll
- Excellent general health, having no acute or chronic health problems and taking no current medications
- Age 13-25 yrs, in puberty (age matched with obese subjects)
- Girls who are sexually active must use adequate birth control methods (such as barrier method or oral contraception) and must have a negative pregnancy test
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00845559
Start Date
August 1 2008
Last Update
December 11 2012
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