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

Tehran University of Medical Sciences

Status and phase: Completed; Phase 2

Conditions: Fatty Liver

Treatments: Drug: Pentoxifylline; Behavioral: Lifestyle modification

Study type: Interventional

Funder types: Other

Identifiers

NCT02283710

9011160012

Details and patient eligibility

About

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 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.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups

Pentoxifylline + lifestyle modification

Experimental group

Description:

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

Treatment:

Drug: Pentoxifylline

Behavioral: Lifestyle modification

Lifestyle modification

Experimental group

Description:

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

Treatment:

Behavioral: Lifestyle modification