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

Phase 2

Completed

• Conditions: Fatty Liver
• Interventions: Behavioral: Lifestyle modification; Drug: Pentoxifylline

• Registration Number: NCT02283710
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

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.

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.

Study Timeline

• Study Start: 2013-05
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2014-11
• Study First Submitted: 2014-11-01
• Study First Submitted QC: 2014-11-04
• Study First Posted: 2014-11-05
• Last Update Submitted: 2014-11-05
• Last Update Posted: 2014-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lifestyle modification	Lifestyle modification	Obtaining ideal body weight by calorie restriction diet and programmed physical activity.
Pentoxifylline + lifestyle modification	Lifestyle modification	Pentoxifylline for 6 months plus obtaining ideal body weight by calorie restriction diet and programmed physical activity.
Pentoxifylline + lifestyle modification	Pentoxifylline	Pentoxifylline for 6 months plus obtaining ideal body weight by calorie restriction diet and programmed physical activity.

Primary Outcome Measures

Name	Time	Method
Change from baseline serum alanine aminotransferase at 6 months	6 months

Secondary Outcome Measures

Name	Time	Method
Change from baseline serum aspartate aminotransferase at 6 months	6 months

Trial Locations

Locations (1)

Gastroenterology clinic, Sina Hospital; 🇮🇷 Tehran, Iran, Islamic Republic of