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

November 5, 2014 updated by: Raika Jamali, MD, Tehran University of Medical Sciences

The Effect of Pentoxifylline on Liver Function Tests in Non-alcoholic Fatty Liver Disease Patients Refereed to Sina Hospital Gastroenterology Clinic

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pentoxifylline + lifestyle modification
Pentoxifylline for 6 months plus obtaining ideal body weight by calorie restriction diet and programmed physical activity.
Drug: Pentoxifylline
Pentoxifylline 600 mg BD
Behavioral: Lifestyle modification
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.
Behavioral: Lifestyle modification
obtaining ideal body weight by calorie restriction diet and programmed physical activity.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tehran University of Medical Sciences

Investigators

  • Principal Investigator: Raika Jamali, M.D., Tehran University Of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

November 1, 2014

First Submitted That Met QC Criteria

November 4, 2014

First Posted (Estimate)

November 5, 2014

Study Record Updates

Last Update Posted (Estimate)

November 6, 2014

Last Update Submitted That Met QC Criteria

November 5, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9011160012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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