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

NCT00845559 | Withdrawn Phase 4

• 1 other identifier: 0801003390
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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 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

Conditions

Obesity; Insulin Resistance; Impaired Glucose Tolerance; Cardiovascular Disease

Keywords

Childhood Obesity; Insulin resistance; Impaired Glucose Tolerance; Cardiovascular Disease; Type 2 Diabetes Mellitus; Continuous Glucose Monitoring (CGMS); Exenatide; Oral Glucose Tolerance Test

Outcome Measures

Primary Outcomes (1)

• Whether treatment with exenatide attenuates post-prandial glycemic excursions as assessed by oral glucose tolerance testing (OGTT) and continuous monitoring system (CGMS) technology.

  OGTT (Pre- and post-intervention), CGMS (Pre-intervention, 2-months and post-intervention)

Secondary Outcomes (2)

• Cardiovascular risk parameters will be assessed via flow mediated vasodilation, peripheral arterial tonometry, a self-paced step test and biochemical markers of vascular health.

  Pre- (baseline) and post- (4-months) intervention

• Change in body mass index (BMI).

  Pre-intervention, 2-month and post-intervention.

Study Arms (2)

Exenatide

EXPERIMENTAL

Subjects randomized to treatment will receive a four month supply of exenatide.

Drug: Exenatide

No Treatment

NO INTERVENTION

Interventions

Exenatide DRUG

Subjects randomized to treatment will receive a four month supply of exenatide and will be taught how to administer subcutaneous injections with their exenatide pen and instructed on the following dosing schedule: exenatide - 5 μg twice a day for 7 days, followed by exenatide 10 μg twice a day for the remainder of the four month supply.

Also known as: Byetta

Exenatide

Eligibility Criteria

• Age: 13 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• Amylin Pharmaceuticals, LLC.: collaborator

MeSH Terms

Conditions

Obesity; Insulin Resistance; Glucose Intolerance; Cardiovascular Diseases; Pediatric Obesity; Diabetes Mellitus, Type 2

Interventions

Exenatide

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Hyperglycemia; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors

Study Officials

• Tania S Burgert, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2009
• First Posted: February 18, 2009
• Study Start: August 1, 2008
• Primary Completion: March 1, 2010
• Last Updated: December 11, 2012

Record last verified: 2012-12