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

Study Overview
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Brief Summary
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In this study, consecutive patients with cryptogenic cirrhosis (NASH-related cirrhosis), coming to ILBS (Institute of Liver & Biliary Sciences) OPD (Out patient Department) or getting admitted in the ward will be enrolled on fulfillment of inclusion/exclusion criteria and consent of the patient. 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. At the end of the study, outcome will be measured appropriately.

Official Title
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Effect of Metformin on Disease Progression in Patients With Cryptogenic Cirrhosis (NASH-related Cirrhosis) With Diabetes or Impaired Glucose Tolerance or Insulin Resistance: a Prospective Randomized, Open Labeled, Clinical Trial

Conditions
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NASH Related Cirrhosis

Intervention / Treatment
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* Drug: Metformin
* Drug: Insulin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years and above Patients with cryptogenic cirrhosis {NASH (Nash Alcoholic Steatohepatitis)-related cirrhosis} Presence of diabetes mellitus or insulin resistance Exclusion Criteria: Patients with heart failure Patients with acute kidney injury at the time of enrollment Patients with CKD (Chronic Kidney Disease) or with S. Creatinine > 1 mg/dL Patient with active upper GI bleeding- not settled Patient with SIRS/sepsis/shock Patient in ICU (Intensive Care Unit) Pregnancy Patients with hepatocellular carcinoma Patients who are not willing to participate in the study Patients with any form of decompensation at the time of enrollment in the study Patient with large esophageal varices/ patients who are on beta blocker other than those patients with HVPG (Hepatic Venous Pressure Gradient) non responder to betablocker Patient who has already been receiving Metformin prior to enrollment in the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metformin<br>Metformin- 500 mg once daily as a starting dose, can be escalated to 2 g/day to control diabetes | Drug: Metformin<br> <br> |
| Active Comparator: Insulin<br> | Drug: Insulin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of portal pressure |  | 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in fibrosis(assessed by noninvasive methods like Fibroscan and Fib 4 index) |  | 1 Year | 
| Safety profile of the drugs like Random Blood Sugar (RBS) and serum lactate monitoring regularly. |  | 1.5 year |