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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Brief Summary

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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.

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Detailed Description

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Conditions

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Nonalcoholic Fatty Liver Disease

Study Groups

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Metformin, Adiponectine, Arterial Compliance

Group Type EXPERIMENTAL

Metformin

Intervention Type DRUG

Interventions

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Metformin

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No