About The Study

The aim of this study is to evaluate the role of Metformin in preventing the progression and promoting the regression of liver fibrosis in individuals that are either co-infected with HCV-HIV or mono-infected with HCV (hepatitis C virus), have insulin resistance (IR), and are receiving antiviral HCV-treatment.

About The Disease

A build-up of scar tissue is part of the healing process of the liver when it is injured. However, this scar tissue can cause the liver to become stiffer and not function properly. When this happens, it is called liver fibrosis and can lead to cirrhosis and end-stage liver disease. Hepatitis, which affects the liver, prevents this organ from operating properly and can lead to a number of health issues throughout the body, including insulin resistance.

Insulin resistance occurs when the insulin secreted by the body does not work as effectively as it should and higher levels of insulin are needed to have the same effect. If left untreated, IR can progress and develop into type 2 diabetes. There is a known relationship between HCV and IR. It is believed that IR in HCV-infected patients may impact the effectiveness of HCV antiviral therapy and liver outcomes. Specifically, a number of studies in HCV-HIV co-infected patients and HCV mono-infected patients have found that liver disease (fibrosis) progresses quicker in HCV-infected patients with IR.

Metformin, a type of drug known as an insulin sensitizer, can delay or prevent the onset of diabetes in non-infected people. This drug also improves treatment outcomes in those infected with HCV. What we don’t know about this drug is whether it can prevent the development of diabetes and liver fibrosis in patients receiving treatment for HCV.

Study Approach

This study will enrol 60 research participants at The Ottawa Hospital. It will involve 8 visits over 52 weeks.

This is a randomized study, meaning participants will have the same chance of being placed in either group. Participants will be assigned through a computer selection process to one of the two treatment groups. This study is open-label which means that both the participant and their doctor will know which group they are in.

Group 1: will receive Metformin.

Group 2: will not receive Metformin; this is the control group and will act as a comparison group

ALL participants will receive education on lifestyle and diet changes that help reduce the progression of liver disease. The change in liver fibrosis over time will be compared between the two treatment groups.

Eligibility Requirements

Required

PLEASE NOTE: This study has been terminated.

Additional Information

If you would like more information on this clinical study, please contact the Principal Investigator or visit clinicaltrials.gov.

Principal Investigator

Here’s who is leading this study.

Can’t find what you’re looking for? Email ctninfo@hivnet.ubc.ca.

Dr. Curtis Cooper

Co-Leader, Co-infections and Related Conditions Core; Member, Steering Committee

University of Ottawa; The Ottawa Hospital

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Participating Site

Here’s where this study is being conducted.