Acute Effect of Exenatide on Brain Glucose Metabolism

What Was Tested

The trial (phase 4) is built around Exenatide.

This research study will examine brain glucose metabolism after an overnight fast to determine the effect of exenatide on brain glucose metabolism and lipid metabolism.

It had two arms (groups): Exenatide first, then Placebo (experimental) and Placebo first, then Exenatide (experimental).

The registry classes the interventions as drug.

More on the Plan

This study will elucidate if exenatide has an effect on brain glucose metabolism.

This will be accomplished by measuring the rate of glucose binding in various brain regions by Positron Emission Tomography (PET) after glucose load with exenatide injection and compare it with placebo injection measured in the same subject.

The changes will be compared with peripheral and hepatic glucose metabolism and lipolysis.

Who Took Part

The registry lists 15 actual participants took part.

It was open to men only aged from 18 years up to 65 years.

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

Examples of who could join: Males age 18-65 years old. Patients must have Body Mass Index (BMI) between 25 and 40 kg/m2. Patients must have BMI of 25-40 kg/m2. Patients must have no known severe liver or kidney disease, cancer, neurologic, psychiatric or systemic disease, ability to understand the study. Only patients whose body weight has been stable (±3-4 pounds) over the three months prior to study will be included.

The full record lists 13 inclusion and 7 exclusion criteria; among the exclusions: patients with major chronic illness (cancer, liver, kidney, cardiovascular disease); patients with bmi over 40 and under 25; patient with age below 18 yrs and over 65 yrs.

How the Study Was Run

It was run as a randomized, crossover and quadruple-blind study.

Random assignment meant chance, not the researchers, decided who got Exenatide and who got the comparison, which limits bias.

Each person switched between Exenatide and the comparison at some point, usually with a gap in between.

Blinding on both sides kept the participants and researchers unaware of who received Exenatide.

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

It started in 2010-07 with completion listed for 2015-07.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Effect of Exenatide on Brain (Total Gray Matter) Glucose Metabolism (time frame: 120 minutes after exenatide or placebo injection).

It also tracked 1 secondary outcome, for example Effect of Exenatide on the Liver and Adipose Tissue Glucose Uptake.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Exenatide in 15 people.

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

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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