Antidiabetic Effects on Intrahepatic Fat

What Was Tested

The trial (phase 4) is built around Liraglutide for fatty liver & elevated liver enzymes.

This was a 24-week single-center, open-label, parallel controlled group comparing gliclazide, liraglutide, and metformin effects on diabetes with nonalcoholic fatty liver disease.

It had three arms (groups): Liraglutide (active comparator), Metformin (active comparator) and Gliclazide (active comparator).

The registry classes the interventions as drug.

More on the Plan

All patients were informed about a proper diet and exercise.

Who Took Part

Enrollment: 87 actual participants took part.

It was open to people of any sex aged from 17 years up to 80 years.

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

Examples of who could join: Age: 18-70 years;. Type 2 diabetes mellitus;. Not used antidiabetic drugs within 3 months;. Female subjects：post-menopausal women, take contraceptive measures three months before the test screening and can persist throughout the experimental period;. Patients signed the informed consent.

The full record lists 8 inclusion and 14 exclusion criteria; among the exclusions: suffering from pancreatitis or other pancreatic diseases or have other similar history;; GLP-1 analogs or sulfonylurea allergy history;; liver dysfunction (aspartate aminotransferase ≥ 2.5 times of the normalupper limit);.

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 2014-05 with completion listed for 2014-11.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Intrahepatic fat (time frame: -7±3days; 168±3days).

It also tracked 9 secondary outcomes, for example Liver function, Lipid, Plasma glucose in standard meal tolerance test, Plasma insulin in standard meal tolerance test, Glucose control and HbA1c.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Liraglutide in 87 people with fatty liver & elevated liver enzymes.

The trial is marked completed; 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.