Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070, India
Completed
NCT Number: NCT02234440
Effect of Metformin on Disease Progression in Patients With Cryptogenic Cirrhosis (NASH-related Cirrhosis) With Diabetes or Impaired Glucose Tolerance or Insulin Resistance
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.
Completed
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Age 18 years and above
- Patients with cryptogenic cirrhosis {NASH (Nash Alcoholic Steatohepatitis)-related cirrhosis}
- Presence of diabetes mellitus or insulin resistance
Exclusion criteria
- 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
Treatment and study plan
metformin
DrugInsulin
DrugPrimary outcomes
-
Reduction of portal pressure
Time frame: 1 Year
Secondary outcomes
-
Improvement in fibrosis(assessed by noninvasive methods like Fibroscan and Fib 4 index)
Time frame: 1 Year
-
Safety profile of the drugs like Random Blood Sugar (RBS) and serum lactate monitoring regularly.
Time frame: 1.5 year
Sponsors and collaborators
Lead sponsor
Institute of Liver and Biliary Sciences, India
Other
Registry information
Official study 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"
Important dates
- Study start
- 2014
- Primary completion
- 2015
- Study completion
- 2015
- First posted
- Sep 9, 2014
- Registry last updated
- Feb 8, 2018
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.