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

NCT02234440 | Completed

• 1 other identifier: ILBS-NASH-Cirrhosis-01
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

NASH Related Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Reduction of portal pressure

  1 Year

Secondary Outcomes (2)

• 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

Study Arms (2)

Metformin

EXPERIMENTAL

Metformin- 500 mg once daily as a starting dose, can be escalated to 2 g/day to control diabetes

Drug: Metformin

Insulin

ACTIVE COMPARATOR

Drug: Insulin

Interventions

Metformin DRUG

Metformin

Insulin DRUG

Insulin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years and above
• Patients with cryptogenic cirrhosis {NASH (Nash Alcoholic Steatohepatitis)-related cirrhosis}
• Presence of diabetes mellitus or insulin resistance

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location

MeSH Terms

Interventions

Metformin; Insulin

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Dr Tanmay S Vyas, MD

  Institute of Liver and Biliary Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2014
• First Posted: September 9, 2014
• Study Start: September 1, 2014
• Primary Completion: December 31, 2015
• Study Completion: December 31, 2015
• Last Updated: February 8, 2018

Record last verified: 2016-02

Locations

IN (1)