The Effects of Exenatide on Post-Meal Sugar Peaks and Vascular Health in Obese/Pre-Diabetic Young Adults

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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 interested in include:

• The percent of glucose values above 140 mg/dl and/or AUC of glucose values above 140 mg/dl

• AUC of glucose values over 100 mg/dl during three days

• Maximal meal-related glucose excursions

• Three-day mean glucose (including low readings - below 100 mg/dl)

Secondary Study Endpoints:

Secondary endpoints will include:

• glucose tolerance status as assessed by OGTT

• Vascular function scores as assessed by PAT, FMD and step test.

• Biochemical markers of vascular health, including inflammatory markers, markers of oxidative stress and microalbuminuria.

• Changes in BMI

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Yale University
• Collaborator: Amylin Pharmaceuticals, LLC.
• Treatments: Exenatide

Criteria

Obese subjects:

Major Inclusion Criteria:

• 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 Criteria:

• 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

Exclusion Criteria:

• Raynaud's syndrome

• Pregnancy or breastfeeding mothers

• Cigarette smokers

• Psychiatric disorders

• History of substance abuse

• First degree relative with either T1DM or T2DM

• Presence of acanthosis nigricans