Effect Of Exenatide Treatment on Liver Fat Content in Patients With Diabetes

What Was Tested

This registered phase 4 trial tested Exenatide.

The purpose of this study is to examine the effect of exenatide, an anti-diabetes medication, on liver fat and blood levels of proteins that influence liver fat.

It had two arms (groups): Pioglitazone and exenatide (experimental) and Pioglitazone (experimental).

The registry classes the interventions as drug.

More on the Plan

The adipocyte functions not only as a storage depot for fat but as an endocrine organ that releases hormones in response to specific extracellular stimuli or changes in metabolic status.

These secreted proteins, carry out a variety of diverse functions, and they have been referred to collectively as adipokines.

Fatty liver is common in type 2 diabetic patients.

The thiazolidinediones initiate their action by binding the peroxisome proliferator activator receptors (PPAR) , which primarily are located on adipocytes.

Who Took Part

24 actual participants took part.

It was open to people of any sex aged from 30 years up to 70 years.

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

Examples of who could join: Patients must range in age from 30 to 70 years. Patients must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent. Patients may be of either sex. Female patients must be non-lactating and must either be at least two years post-menopausal, or be using adequate contraceptive precautions or be surgically sterilized. Patients must meet the American Diabetes Association Criteria for diagnosis of type 2 diabetes mellitus. Subjects whose body weight has been stable (±1 Kg) over the three months prior to study will be included.

The full record lists 7 inclusion and 0 exclusion criteria.

How the Study Was Run

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

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

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

Everyone knew when Exenatide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2007-06 with completion listed for 2008-07.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Hepatic Fat (time frame: one year).

It also tracked 1 secondary outcome, for example Plasma Adipocytokines.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Exenatide in 24 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.