NASH Related Cirrhosis Clinical Trial
Official title:
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"
| Verified date | February 2016 |
| Source | Institute of Liver and Biliary Sciences, India |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 86 |
| Est. completion date | December 31, 2015 |
| Est. primary completion date | December 31, 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| India | Institute of Liver & Biliary Sciences | New Delhi | Delhi |
| Lead Sponsor | Collaborator |
|---|---|
| Institute of Liver and Biliary Sciences, India |
India,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Reduction of portal pressure | 1 Year | ||
| Secondary | Improvement in fibrosis(assessed by noninvasive methods like Fibroscan and Fib 4 index) | 1 Year | ||
| Secondary | Safety profile of the drugs like Random Blood Sugar (RBS) and serum lactate monitoring regularly. | 1.5 year |