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

Institute of Liver and Biliary Sciences, India

Status: Completed

Conditions: NASH Related Cirrhosis

Treatments: Drug: Metformin; Drug: Insulin

Study type: Interventional

Funder types: Other

Identifiers

NCT02234440

ILBS-NASH-Cirrhosis-01

Details and patient eligibility

About

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.

Enrollment: 86 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

86 participants in 2 patient groups

Metformin

Experimental group

Description:

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

Treatment:

Drug: Metformin

Insulin

Active Comparator group

Treatment:

Drug: Insulin