Effect of Metformin on Disease Progression in Patients With Cryptogenic Cirrhosis (NASH-related Cirrhosis) With Diabetes or Impaired Glucose Tolerance or Insulin Resistance

What Was Tested

In this not phased trial, researchers set out to test Insulin (regular human) for insulin resistance, prediabetes & type 2 diabetes.

These patients will be randomised to either metformin arm or conventional treatment arm.

After enrollment these subjects will be monitored every three monthly for total of 12 months or till the primary endpoint is achieved.

It had two arms (groups): Metformin (experimental) and Insulin (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 86 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: Age 18 years and above. Patients with cryptogenic cirrhosis {NASH (Nash Alcoholic Steatohepatitis)-related cirrhosis}. Presence of diabetes mellitus or insulin resistance.

The full record lists 3 inclusion and 12 exclusion criteria; among the exclusions: patients with heart failure; patients with acute kidney injury at the time of enrollment; patient with active upper gi bleeding- not settled.

How the Study Was Run

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

Because people in this Insulin (regular human) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the insulin resistance, prediabetes & type 2 diabetes participants stayed in one arm throughout.

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

It started in 2014-09-01 with completion listed for 2015-12-31.

It ran at 1 site in India.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 2 secondary outcomes, for example Safety profile of the drugs like Random Blood Sugar (RBS) and serum lactate monitoring regularly.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin (regular human) in 86 people with insulin resistance, prediabetes & type 2 diabetes.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin (regular human) compound page, Insulin resistance, prediabetes & type 2 diabetes research.