High Dose Insulin Therapy to Improve Liver Function

What Was Tested

In this not phased trial, researchers set out to test Insulin (regular human).

Insulin resistance is one of the key factors in defining a progressive course of chronic Hepatitis C virus (HCV) infection and hepatic fibrosis.

It had 1 arm (groups): Insulin/dextrose clamp (experimental).

The registry classes the interventions as drug.

Who Took Part

5 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: Hepatitis C positive adult patients (serum HCV antibody positive). MELD score 6-15 at the time of inclusion. Viral genotype "non-3". Not on antiviral therapy.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: HBV or HIV co-infection; evidence of hepatocellular carcinoma at the start of the trial either by imaging and or afp levels above 400; undetectable hcv viral load (using hcv pcr test).

How the Study Was Run

The set-up was single-group and open-label.

Nothing was hidden in this open-label Insulin (regular human) study: the participants and staff both knew the treatment.

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

It started in 2011-01 with completion listed for 2013-12.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 2 secondary outcomes, for example Insulin resistance and Inflammatory mediators.

What This Means in Plain Language

Put simply, this is a not phased trial of Insulin (regular human) in 5 people.

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

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

More context: the Insulin (regular human) compound page, all human trials.