The Effects of Exenatide After Gastric Restriction

What Was Tested

In this phase 2, phase 3 trial, researchers set out to test Exenatide.

The purpose of this study is to describe change in body weight in non-diabetic morbidly obese patients after laparoscopic adjustable gastric banding (LAGB) with twice daily exenatide or placebo injections.

It had two arms (groups): Exenatide (active comparator) and Placebo (placebo comparator).

Laparoscopic adjustable gastric banding group: twice daily exenatide therapy plus a standard diet and exercise program.

Laparoscopic adjustable gastric banding group: twice daily placebo therapy plus a standard diet and exercise program.

The registry classes the interventions as drug.

Who Took Part

The registry lists 28 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age ≥ 18 years,. Have a body mass index ≥ 40 kg/m2 or ≥ 35 kg/m2 with comorbidities (1991 NIH Guidelines for Bariatric Surgery),. For women of childbearing age, must have a negative pregnancy test at screening, and agree to use barrier contraceptives for the duration of the study, AND. Are able to understand and comply with the study process, and give informed consent.

The full record lists 4 inclusion and 13 exclusion criteria; among the exclusions: A diagnosis of type 1 diabetes mellitus,; have experienced hypersensitivity reaction or a worsening of glycemic control on byetta® (exenatide),; patients with end stage renal disease or severe renal impairment,.

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

Because people in this Exenatide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on Exenatide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2009-02 with completion listed for 2010-12.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: To describe change in body weight in non-diabetic morbidly obese patients after laparoscopic adjustable gastric banding (LAGB) with twice daily exenatide plus lifestyle modification plan or placebo plus lifestyle modification plan (time frame: 52 weeks).

It also tracked 4 secondary outcomes, for example Body Mass Index (BMI), Waist circumference, Changes in: 2 hour Oral Glucose Tolerance Test; Lipid panel; Comprehensive metabolic panel; Glycosylated hemoglobin A1c and Carotid intima media thickness(CIMT).

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Exenatide in 28 people.

Its size is small, so on its own it can only give an early look.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Exenatide compound page, all human trials.