Effect of Treatment With Insulin Sensitizer on Arterial Properties, Metabolic Parameters and Liver Function in Patients With Nonalcoholic Fatty Liver Disease

Phase 1

Completed

• Conditions: Nonalcoholic Fatty Liver Disease
• Interventions: Drug: Metformin

• Registration Number: NCT01084486
• Lead Sponsor: Wolfson Medical Center

Brief Summary

Abstract

Background: Insulin resistance has an important role in the development of nonalcoholic fatty liver disease (NAFLD) and is involved in both pathological processes: hepatic steatosis and atherosclerosis. Therefore, treatment of NAFLD with insulin sensitizers is likely to have a favorable effect towards hepatic steatosis and cardiovascular outcomes.

Objectives: The present study investigated the effect of metformin on arterial properties, metabolic parameters and liver function in patients with NAFLD. Methods In randomized, placebo controlled study, 63 patients with NAFLD were assigned to one of two groups: Group 1 received daily metformin; Group 2 received placebo. Pulse wave velocity (PWV) and augmentation index (AI) were performed using SphygmoCor (version 7.1, AtCor Medical, Sydney, Australia) at baseline and at the end of 4-month treatment period.. Metabolic measures and serum adiponectin levels were determined.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-03
• Study First Submitted: 2010-03-09
• Study First Submitted QC: 2010-03-09
• Last Update Submitted: 2010-03-09
• Study First Posted: 2010-03-10
• Last Update Posted: 2010-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• In a single-center study, 63 patients (32 males and 31 females) diagnosed with nonalcoholic fatty liver disease were recruited from the outpatient clinic and evaluated for the study.

Exclusion Criteria

• Patients with history of unstable angina, MI, CVA or major surgery within the six months preceding entrance to the study.
• Patients with unbalanced endocrine disease or any disease that might affect absorption of medications.
• Patients with plasma creatinine > 1.5 mg/dl, and electrolyte abnormalities.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Metformin, Adiponectine, Arterial Compliance	Metformin	-

Trial Locations

Locations (1)

Wolfson Medical Center; 🇮🇱 Holon, Israel