Improving Insulin Resistance To Treat Non-Alcoholic Fatty Liver Disease: A Pilot Study

• Status: Withdrawn
• Trial end date: 2017-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Metformin is being compared to exercise and diet modifications. The researchers are interested in learning if the addition of metformin to lifestyle modifications is more helpful in treating the condition or disorder. Although metformin is FDA approved to treat type 2 diabetes, it is not FDA approved for the treatment of Non-alcoholic fatty liver (NAFLD) and is considered investigational for the purpose of this study.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Northwell Health
• Treatments: Metformin

Criteria

Inclusion Criteria:

• subjects between ages 18-80

• diagnosed with NAFLD by alanine aminotransferase

• (ALT) levels >1.5x the upper limit of normal with an otherwise nondiagnostic hepatic serology workup, ultrasound evidence, and/or histologically confirmed NAFLD within the past 1 year.

• The upper limit of normal for ALT will be defined as 35 U/L in males and 19 U/L in females

Exclusion Criteria:

• A prior history of diabetes

• Failure to meet criteria for HbA1C screening

• Evidence of hepatic disorders

• Use of insulin or oral hypoglycemic agents

• eGFR <30

• Blood transfusion within past 3 months

• Steroid use in the past 6 months

• Excessive alcohol use (more than 20g per day in women and more than 30g per day in men)

• Acute or unstable congestive heart failure

• Age >80 years old

• Lactic acidosis

• Inability to consent due to cognitive impairment.

• Pregnancy