Anti-diabetic Drugs and Fatty Liver Management

What Was Tested

This registered not phased trial tested Liraglutide for fatty liver & elevated liver enzymes.

Type 2 DM is one of the major risk factors for development of non-alcoholic fatty liver disease.

Until now there is no well-established treatment for fatty liver disease.

It had four arms (groups): Group 1 (active comparator), Group 2 (experimental), Group 3 (experimental) and Group 4 (experimental).

Metformin +/- insulin +/- sulfonylurea.

Metformin plus vildagliptin +/- insulin +/- sulfonylurea.

Metformin plus liraglutide +/- insulin+/- sulfonylurea.

The registry classes the interventions as drug.

More on the Plan

Rational: Type 2 DM is one of the major risk factors for development of non-alcoholic fatty liver disease.

NAFLD diagnostic criteria: * Fatty Liver Index (FLI) 60 or more plus Ultrasound features of fatty liver. \- Inclusion criteria 1.

Age above 18. 2- HbA1C less than 10.

So, 120 subjects will be divided into 4 equal groups.

Who Took Part

120 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Type 2 DM with fatty liver disease. HbA1C less than 10.

The full record lists 2 inclusion and 8 exclusion criteria; among the exclusions: alcohol intake; BMI 40 or more; CKD with e GFR less than 60.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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

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

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

It started in 2021-02-23 with completion listed for 2021-09-30.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in steatosis as measured using CAP score (fibroscan) and MRI (time frame: 12 months).

It also tracked 2 secondary outcomes, for example Change in liver enzymes and Changes in fibrosis grade.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Liraglutide in 120 people with fatty liver & elevated liver enzymes.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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