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

Tehran University of Medical Sciences120 enrolled

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

120

Conditions

Fatty Liver

Interventions

PentoxifyllineDRUG

Pentoxifylline 600 mg BD

Lifestyle modificationBEHAVIORAL

obtaining ideal body weight by calorie restriction diet and programmed physical activity.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Gastroenterology clinic, Sina Hospital

Tehran, Tehran Province, Iran

Outcomes

Primary Outcomes

Change from baseline serum alanine aminotransferase at 6 months

Time frame: 6 months

Secondary Outcomes

Change from baseline serum aspartate aminotransferase at 6 months

Time frame: 6 months

Data from ClinicalTrials.gov

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