Status:
COMPLETED
Effect of Metformin on Disease Progression in Patients With Cryptogenic Cirrhosis (NASH-related Cirrhosis) With Diabetes or Impaired Glucose Tolerance or Insulin Resistance
Lead Sponsor:
Institute of Liver and Biliary Sciences, India
Conditions:
NASH Related Cirrhosis
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- Age 18 years and above
- Patients with cryptogenic cirrhosis {NASH (Nash Alcoholic Steatohepatitis)-related cirrhosis}
- Presence of diabetes mellitus or insulin resistance
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2015
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT02234440
Start Date
September 1 2014
End Date
December 31 2015
Last Update
February 8 2018
Active Locations (1)
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1
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, India, 110070