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Completed

NCT Number: NCT02283710

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Gastroenterology clinic, Sina Hospital

Tehran, Tehran Province, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pentoxifylline

Drug

Pentoxifylline 600 mg BD

Lifestyle Modification

Behavioral

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

Primary outcomes

  1. Change from baseline serum alanine aminotransferase at 6 months

    Time frame: 6 months

Secondary outcomes

  1. Change from baseline serum aspartate aminotransferase at 6 months

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Tehran University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 5, 2014
Registry last updated
Nov 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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