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

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"

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.

Study Overview

• Status: Completed
• Conditions: NASH Related Cirrhosis
• Intervention / Treatment: Drug: Metformin; Drug: Insulin

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110070
      • Institute of Liver & Biliary Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Insulin	Drug: Insulin
Experimental: Metformin; Metformin- 500 mg once daily as a starting dose, can be escalated to 2 g/day to control diabetes	Drug: Metformin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Reduction of portal pressure	1 Year

Secondary Outcome Measures

Outcome Measure	Time Frame
Improvement in fibrosis(assessed by noninvasive methods like Fibroscan and Fib 4 index)	1 Year
Safety profile of the drugs like Random Blood Sugar (RBS) and serum lactate monitoring regularly.	1.5 year

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India
• Investigators: Principal Investigator: Dr Tanmay S Vyas, MD, Institute of liver and Biliary Sciences

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2014
• Primary Completion (Actual): December 31, 2015
• Study Completion (Actual): December 31, 2015

Study Registration Dates

• First Submitted: August 31, 2014
• First Submitted That Met QC Criteria: September 8, 2014
• First Posted (Estimate): September 9, 2014

Study Record Updates

• Last Update Posted (Actual): February 8, 2018
• Last Update Submitted That Met QC Criteria: February 7, 2018
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease Attributes; Liver Diseases; Hyperinsulinism; Hyperglycemia; Fibrosis; Disease Progression; Liver Cirrhosis; Glucose Intolerance; Insulin Resistance; Hypoglycemic Agents; Physiological Effects of Drugs; Metformin
• Other Study ID Numbers: ILBS-NASH-Cirrhosis-01