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

Fatty Liver Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02283710
• Other study ID #: 9011160012
• Status: Completed
• Phase: Phase 2
• First received: November 1, 2014
• Last updated: November 5, 2014
• Start date: May 2013
• Est. completion date: May 2014

Study information

• Verified date: November 2014
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases

Intervention

Drug:
• Pentoxifylline
Pentoxifylline 600 mg BD

Behavioral:
• Lifestyle modification
obtaining ideal body weight by calorie restriction diet and programmed physical activity.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Gastroenterology clinic, Sina Hospital	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline serum alanine aminotransferase at 6 months		6 months	Yes
Secondary	Change from baseline serum aspartate aminotransferase at 6 months		6 months	Yes