Overview

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

Status:
Completed
Trial end date:
2015-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Institute of Liver and Biliary Sciences, India
Treatments:
Insulin
Insulin, Globin Zinc
Metformin
Criteria
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