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

What Was Tested

The trial (phase 4) is built around Exenatide for insulin resistance, prediabetes & type 2 diabetes.

The primary aim of this study is to evaluate the effect of exenatide on daily glycemic excursions obtained by continuous glucose monitoring system (CGMS).

It had two arms (groups): Exenatide (experimental) and No Treatment (no intervention).

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

The registry classes the interventions as drug.

More on the Plan

There will also be a lean control group for baseline assessments only.

One arm will be exenatide the other arm will be no drug.

Subjects will be stratified according to state of glucose tolerance.

Stratification will also occur according to gender and family history of premature cardiovascular disease.

Who Took Part

It was open to people of any sex aged from 13 years up to 25 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Insulin resistance: fasting insulin\> 25 mIU/ml. Good general health, taking no medication on a chronic basis. 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.

The full record lists 6 inclusion and 28 exclusion criteria; among the exclusions: hx of gallstones; hx of alcohol use/ binge drinking; raynaud's syndrome.

How the Study Was Run

Design: randomized, parallel-group and open-label.

The insulin resistance, prediabetes & type 2 diabetes participants were allocated by chance, so the Exenatide group and the comparison group should start out alike.

Groups ran in parallel: each of the insulin resistance, prediabetes & type 2 diabetes participants stayed in one arm throughout.

Being open-label, the Exenatide study did not mask who received what.

It started in 2008-08 with completion listed for 2010-03.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Whether treatment with exenatide attenuates post-prandial glycemic excursions as assessed by oral glucose tolerance testing (OGTT) and continuous monitoring system (CGMS) technology (time frame: OGTT (Pre- and post-intervention), CGMS (Pre-intervention, 2-months and post-intervention)).

It also tracked 2 secondary outcomes, for example Change in body mass index (BMI).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Exenatide in people with insulin resistance, prediabetes & type 2 diabetes.

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Exenatide compound page, Insulin resistance, prediabetes & type 2 diabetes research.