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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02234440

Enrollment

Registered

2014-09-09

Start date

2014-09-01

Completion date

2015-12-31

Last updated

2018-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NASH Related Cirrhosis

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.

Interventions

DRUGMetformin

DRUGInsulin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Reduction of portal pressure	1 Year

Secondary

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

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026