Effects Of Exenatide On Liver Biochemistry, Liver Histology And Lipid Metabolism In Patients With Fatty Liver Disease

What Was Tested

This registered phase 2 trial tested Exenatide for fatty liver & elevated liver enzymes.

Non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) are common complications of type 2 diabetes and leading causes of liver disease in the US and Europe.

It had 1 arm (groups): Exenatide (experimental).

The registry classes the interventions as drug.

More on the Plan

Hepatocytes express GLP-1 receptors that are responsive to both GLP-1 and exenatide.

Characterize the effects of exenatide on serum levels of adipokines and inflammatory cytokines including adiponectin, leptin and TNF- in NAFLD patients.

Compare the hepatic expression of SCD1, SREBP-1c and PPAR- mRNA in NAFLD patients pre- and post-treatment with exenatide.

Establish the effects of exenatide on post-prandial lipid metabolism.

Who Took Part

Enrollment: 1 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Age \>18 years, \< 70 years, inclusive. Body mass index \> 35 kg/m2. Presumed diagnosis of NAFLD based upon. An ALT \> 1.5 times the upper limit of reference range,. No evidence of other causes of liver disease and.

The full record lists 7 inclusion and 18 exclusion criteria; among the exclusions: clinical signs of cirrhosis as evidenced by any of the following; spider angiomata,; INR \> 1.2.

How the Study Was Run

Design: single-group and open-label.

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.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2007-10 with completion listed for 2009-07.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 2 secondary outcomes, for example Changes in Components of Liver Histology at Baseline and Week 24 Including Steatosis, Inflammation and Fibrosis and Safety of Exenatide in Patients With NAFLD and Type 2 Diabetes.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Exenatide in 1 people with fatty liver & elevated liver enzymes.

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

It ended early (terminated); results are posted on the registry, and this page does not restate them.

More context: the Exenatide compound page, Fatty liver & elevated liver enzymes research.