The Effect of Pentoxifylline on Liver Function Tests in Fatty Liver Disease

Overview

This randomized double blind clinical trial was performed in patients with non-alcoholic fatty liver disease.They were randomly assigned to lifestyle modification alone or lifestyle modification plus Pentoxifylline groups. Liver function tests, metabolic profile and anthropometric measurements were checked at baseline and six months later.

Full Title of Study: “The Effect of Pentoxifylline on Liver Function Tests in Non-alcoholic Fatty Liver Disease Patients Refereed to Sina Hospital Gastroenterology Clinic”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Care Provider, Outcomes Assessor)
  • Study Primary Completion Date: May 2014

Detailed Description

This randomized double blind clinical trial was performed in patients with the evidence of fatty liver in ultrasonography. After excluding other causes, participants with persistent elevated serum aminotransferase levels were presumed to have NAFLD. Those with NAFLD liver fat score greater than (-0.64) were enrolled. They were randomly assigned to lifestyle modification alone or lifestyle modification plus Pentoxifylline groups. Fasting serum glucose, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, triglyceride, cholesterol, high and low-density lipoprotein,homeostasis model assessment-insulin resistance(HOMA-IR), and anthropometric measurements (body mass index and waist circumference) were checked at baseline and six months later.

Interventions

  • Drug: Pentoxifylline
    • Pentoxifylline 600 mg BD
  • Behavioral: Lifestyle modification
    • obtaining ideal body weight by calorie restriction diet and programmed physical activity.

Arms, Groups and Cohorts

  • Experimental: Pentoxifylline + lifestyle modification
    • Pentoxifylline for 6 months plus obtaining ideal body weight by calorie restriction diet and programmed physical activity.
  • Experimental: Lifestyle modification
    • Obtaining ideal body weight by calorie restriction diet and programmed physical activity.

Clinical Trial Outcome Measures

Primary Measures

  • Change from baseline serum alanine aminotransferase at 6 months
    • Time Frame: 6 months

Secondary Measures

  • Change from baseline serum aspartate aminotransferase at 6 months
    • Time Frame: 6 months

Participating in This Clinical Trial

Inclusion Criteria

Patients with persistent elevated aminotransferase levels and the evidence of fatty liver in ultrasonography, who were referred to a gastroenterology clinic. Exclusion Criteria:

  • alcohol use (more than 20 gram per day in men and 10 gram per day in women per day), – heart disease (ischemic or congestive), – hepatic disease (viral hepatitis, autoimmune hepatitis, wilson disease, hemochromatosis, liver mass lesion), – renal disease (serum creatinine concentration of > 1.5 mg/dl), – any severe systemic co-morbidities, neoplasm, – using any hepatotoxic medication during the past 3 months, – pregnant or lactating women.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Tehran University of Medical Sciences
  • Provider of Information About this Clinical Study
    • Principal Investigator: Raika Jamali, MD, Associate Professor of Medicine – Tehran University of Medical Sciences
  • Overall Official(s)
    • Raika Jamali, M.D., Principal Investigator, Tehran University of Medical Sciences

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