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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2014-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Fatty Liver

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Pentoxifylline + lifestyle modification

Pentoxifylline for 6 months plus obtaining ideal body weight by calorie restriction diet and programmed physical activity.

Group Type EXPERIMENTAL

Pentoxifylline

Intervention Type DRUG

Pentoxifylline 600 mg BD

Lifestyle modification

Intervention Type BEHAVIORAL

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

Lifestyle modification

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

Group Type EXPERIMENTAL

Lifestyle modification

Intervention Type BEHAVIORAL

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

Interventions

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Pentoxifylline

Pentoxifylline 600 mg BD

Intervention Type DRUG

Lifestyle modification

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No