Back to resultsEffect of Metformin on Disease Progression in Patients With Cryptogenic Cirrhosis (NASH-related Cirrhosis) With Diabetes or Impaired Glucose Tolerance or Insulin Resistance
Primary Purpose
NASH Related Cirrhosis
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Metformin
Insulin
Sponsored by
About this trial
This is an interventional treatment trial for NASH Related Cirrhosis
Eligibility Criteria
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
Sites / Locations
- Institute of Liver & Biliary Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Metformin
Insulin
Arm Description
Metformin- 500 mg once daily as a starting dose, can be escalated to 2 g/day to control diabetes
Outcomes
Primary Outcome Measures
Reduction of portal pressure
Secondary Outcome Measures
Improvement in fibrosis(assessed by noninvasive methods like Fibroscan and Fib 4 index)
Safety profile of the drugs like Random Blood Sugar (RBS) and serum lactate monitoring regularly.
Full Information
NCT ID
NCT02234440
First Posted
August 31, 2014
Last Updated
February 7, 2018
Sponsor
Institute of Liver and Biliary Sciences, India
1. Study Identification
Unique Protocol Identification Number
NCT02234440
Brief Title
Effect of Metformin on Disease Progression in Patients With Cryptogenic Cirrhosis (NASH-related Cirrhosis) With Diabetes or Impaired Glucose Tolerance or Insulin Resistance
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"
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
September 1, 2014 (Actual)
Primary Completion Date
December 31, 2015 (Actual)
Study Completion Date
December 31, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Liver and Biliary Sciences, India
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NASH Related Cirrhosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Metformin
Arm Type
Experimental
Arm Description
Metformin- 500 mg once daily as a starting dose, can be escalated to 2 g/day to control diabetes
Arm Title
Insulin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Type
Drug
Intervention Name(s)
Insulin
Primary Outcome Measure Information:
Title
Reduction of portal pressure
Time Frame
1 Year
Secondary Outcome Measure Information:
Title
Improvement in fibrosis(assessed by noninvasive methods like Fibroscan and Fib 4 index)
Time Frame
1 Year
Title
Safety profile of the drugs like Random Blood Sugar (RBS) and serum lactate monitoring regularly.
Time Frame
1.5 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Tanmay S Vyas, MD
Organizational Affiliation
Institute of Liver and Biliary Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Liver & Biliary Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110070
Country
India
12. IPD Sharing Statement
Learn more about this trial
Effect of Metformin on Disease Progression in Patients With Cryptogenic Cirrhosis (NASH-related Cirrhosis) With Diabetes or Impaired Glucose Tolerance or Insulin Resistance
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