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

Not Applicable

Completed

• Conditions: NASH Related Cirrhosis
• Interventions: Drug: Insulin; Drug: Metformin

• Registration Number: NCT02234440
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-08-31
• Study Start: 2014-09-01
• Study First Submitted QC: 2014-09-08
• Study First Posted: 2014-09-09
• Primary Completion: 2015-12-31
• Study Completion: 2015-12-31
• Status Verified: 2016-02
• Last Update Submitted: 2018-02-07
• Last Update Posted: 2018-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• 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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Insulin	Insulin	-
Metformin	Metformin	Metformin- 500 mg once daily as a starting dose, can be escalated to 2 g/day to control diabetes

Primary Outcome Measures

Name	Time	Method
Reduction of portal pressure	1 Year

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Institute of Liver & Biliary Sciences; 🇮🇳 New Delhi, Delhi, India