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

NCT00845559 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2012-12-11

No results posted yet for this study

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

Interventions

DRUG

Exenatide

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.

Sponsors & Collaborators

  • Amylin Pharmaceuticals, LLC.

    collaborator INDUSTRY

  • Yale University

    lead OTHER

Principal Investigators

  • Tania S Burgert, MD · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2010-03-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00845559 on ClinicalTrials.gov