Effects of Exenatide on Postprandial Hyperlipidemia and Inflammation

What Was Tested

In this phase 4 trial, researchers set out to test Exenatide.

The primary goal of this study is to determine the acute effects of exenatide on postprandial hypertriglyceridemia.

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

The registry classes the interventions as drug and other.

Who Took Part

The registry lists 39 actual participants took part.

It was open to people of any sex aged from 35 years up to 70 years.

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

Examples of who could join: Recently diagnosed type 2 diabetes (within 3 years) on diet or IGT. Normal liver function tests and white blood cell count.

The full record lists 3 inclusion and 12 exclusion criteria; among the exclusions: type 2 diabetes for \> 3 years or hba1c ≥ 7.5; known or suspected type 1 diabetes; any diabetes medications in the past 3 weeks, tzd in the prior 3 months or prior regular use of insulin.

How the Study Was Run

Design: randomized, crossover and quadruple-blind.

The participants were allocated by chance, so the Exenatide group and the comparison group should start out alike.

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

As a double-blind Exenatide study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2006-08 with completion listed for 2008-11.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Triglyceride concentration in serum (time frame: Before and up to 8-hours post-injection).

It also tracked 1 secondary outcome, for example serum or plasma lipoproteins, apolipoproteins and inflammatory markers; endothelial function.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Exenatide in 39 people.

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

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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