Fatty Liver Study in Patients With Type II Diabetes

What Was Tested

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

It had three arms (groups): Thiazolidinedione (active comparator), Lantus Insulin (active comparator) and DPP4 inhibitor (active comparator).

The registry classes the interventions as drug.

More on the Plan

In patients with type 2 diabetes whose glycemic control is not accomplished with Metformin alone, there are several options for additional hypoglycemic agent.

As per recent National guidelines at least three "second line" agents can be added to metformin: thiazolidinediones, Lantus insulin, and DPP4 inhibitors.

Among these abnormalities, excessive triglyceride content in the liver (fatty liver or liver steatosis) is a major predictor of risk for non-alcoholic steato-hepatitis (NASH) and liver cirrhosis.

Fatty liver is highly prevalent in patients with type 2 diabetes.

Who Took Part

5 actual participants took part.

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: Subject has provided informed consent in a manner approved by the Institutional Review Board (IRB) and is willing and able to comply with the trial procedures. Adults at least 18 years of age at the time of consent. Have type 2 diabetes mellitus. Have fatty liver, which is diagnosed by ultrasonographic findings of "bright liver" within 1 year of study enrollment. Stable medication for lipid lowering, blood pressure control, dietary supplements, including vitamins, for at least 3 months.

The full record lists 8 inclusion and 10 exclusion criteria; among the exclusions: currently taking medication that can affect glucose metabolism other than metformin; history of heart failure; concurrent participation on another research study.

How the Study Was Run

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

The fatty liver & elevated liver enzymes participants were allocated by chance, so the Insulin Glargine group and the comparison group should start out alike.

Groups ran in parallel: each of the fatty liver & elevated liver enzymes participants stayed in one arm throughout.

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

It started in 2013-05-01 with completion listed for 2016-12-31.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in Hepatic Lipid Content From Baseline Visit to Six Month Follow up Visit.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine in 5 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 Insulin Glargine compound page, Fatty liver & elevated liver enzymes research.