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NCT01084486 Clinical Trial

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

Nonalcoholic Fatty Liver Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01084486
Other study ID # WolfsonMC-2007-9
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received March 9, 2010
Last updated March 9, 2010

Study information
Verified date March 2010
Source Wolfson Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 40 Years to 80 Years
Eligibility 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

N/A

Related Conditions & MeSH terms

Intervention

Drug:
• Metformin

Locations
Country Name City State
Israel Wolfson Medical Center Holon

Sponsors (1)
Lead Sponsor Collaborator
Wolfson Medical Center

Country where clinical trial is conducted

Israel, 

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