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Effect of Metformin (Drug)in Patients With Cryptogenic Cirrhosis (Liver Disease) With Diabetes

Not Applicable
Completed
Conditions
Health Condition 1: null- Cryptogenic cirrhosis with DiabetesHealth Condition 2: K746- Other and unspecified cirrhosis ofliver
Registration Number
CTRI/2018/03/012814
Lead Sponsor
Institute of liver and Biliary Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
86
Inclusion Criteria

1)Age 18 years and above

2)Patients with cryptogenic cirrhosis {NASH (Nash Alcoholic Steatohepatitis)-related cirrhosis}

3)Presence of diabetes mellitus or insulin resistance

Exclusion Criteria

1)Patients with heart failure

2)Patients with acute kidney injury at the time of enrollment

3)Patients with CKD (Chronic Kidney Disease) or with S. Creatinine > 1 mg/dL

4)Patient with active upper GI bleeding- not settled

5)Patient with SIRS/sepsis/shock

6)Patient in ICU (Intensive Care Unit)

7)Pregnancy

8)Patients with hepatocellular carcinoma

9)Patients who are not willing to participate in the study

10)Patients with any form of decompensation at the time of enrollment in the study

11)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

12)Patient who has already been receiving Metformin prior to enrollment in the study

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Reduction of portal pressureTimepoint: 1 Year
Secondary Outcome Measures
NameTimeMethod
Improvement in fibrosis(assessed by noninvasive methods like Fibroscan and Fib 4 index)Timepoint: 1 year;Safety profile of the drugs like Random Blood Sugar (RBS) and serum lactate monitoring regularly.Timepoint: 1.5 years
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