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

This study has been completed.
Sponsor:
Information provided by:
Wolfson Medical Center
ClinicalTrials.gov Identifier:
NCT01084486
First received: March 9, 2010
Last updated: NA
Last verified: March 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Nonalcoholic Fatty Liver Disease
 Drug: Metformin
 Phase 1
Phase 2

Study Type: Interventional

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Wolfson Medical Center:

Arms Assigned Interventions
Experimental: Metformin, Adiponectine, Arterial Compliance Drug: Metformin

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01084486

Locations
Israel
Wolfson Medical Center
Holon, Israel, 58100
Sponsors and Collaborators
Wolfson Medical Center
  More Information

No publications provided by Wolfson Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT01084486     History of Changes
Other Study ID Numbers: WolfsonMC-2007-9
Study First Received: March 9, 2010
Last Updated: March 9, 2010
Health Authority: Israel: Ministry of Health

Keywords provided by Wolfson Medical Center:
nonalcoholic fatty liver disease
Pulse wave velocity
augmentation index
metformin

Additional relevant MeSH terms:
Fatty Liver
Liver Diseases
Digestive System Diseases
Metformin
 Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013