Effect of Exenatide on Liver and Heart Fat and Inflammation

What Was Tested

This registered phase 4 trial tested Exenatide.

The purpose of this study is to examine the effect of exenatide on liver and heart (myocardial) fat and inflammation.

It had two arms (groups): Exenatide (experimental) and Glipizide (experimental).

The registry classes the interventions as drug.

More on the Plan

Type 2 diabetics and insulin resistant individuals have an excess of fat in the liver which is not attributable to alcohol or other known causes of liver disease, a condition defined as nonalcoholic fatty liver disease (NAFLD).

The fatty liver is insulin resistant.

Who Took Part

Enrollment: 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 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. Patients must range in age from 30 to 70 years, inclusive. Patients must have Hematocrit greater than 34 vol%. Subjects whose body weight has been stable over the three months prior to study enrollment will be included.

The full record lists 7 inclusion and 7 exclusion criteria; among the exclusions: patients must not have type 1 diabetes; patients must not have received a thiazolidinedione for at least 3 months prior to randomization; patients taking systemic glucocorticoids or other medications known to affect glucose tolerance are excluded.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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

The Exenatide group and the comparison group ran side by side rather than switching.

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

It started in 2010-04 with completion listed for 2012-10.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Myocardial Fat Content (time frame: 6 months). Hepatic Fat Content (time frame: 6 months).

It also tracked 2 secondary outcomes, for example Left Ventricular Ejection Fraction (LVEF)(%) and Monocyte Inflammatory Protein Nuclear Factor Kappa-B (NFkappaB) (%).

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.