The Effect of Pentoxifylline on Liver Function Tests in Fatty Liver Disease
Primary Purpose
Fatty Liver
Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Pentoxifylline
Lifestyle modification
Sponsored by
About this trial
This is an interventional treatment trial for Fatty Liver focused on measuring Pentoxifylline, Aminotransferase, Steatohepatitis
Eligibility Criteria
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.
Sites / Locations
- Gastroenterology clinic, Sina Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Pentoxifylline + lifestyle modification
Lifestyle modification
Arm Description
Pentoxifylline for 6 months plus obtaining ideal body weight by calorie restriction diet and programmed physical activity.
Obtaining ideal body weight by calorie restriction diet and programmed physical activity.
Outcomes
Primary Outcome Measures
Change from baseline serum alanine aminotransferase at 6 months
Secondary Outcome Measures
Change from baseline serum aspartate aminotransferase at 6 months
Full Information
NCT ID
NCT02283710
First Posted
November 1, 2014
Last Updated
November 5, 2014
Sponsor
Tehran University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02283710
Brief Title
The Effect of Pentoxifylline on Liver Function Tests in Fatty Liver Disease
Official Title
The Effect of Pentoxifylline on Liver Function Tests in Non-alcoholic Fatty Liver Disease Patients Refereed to Sina Hospital Gastroenterology Clinic
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tehran University of Medical Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatty Liver
Keywords
Pentoxifylline, Aminotransferase, Steatohepatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pentoxifylline + lifestyle modification
Arm Type
Experimental
Arm Description
Pentoxifylline for 6 months plus obtaining ideal body weight by calorie restriction diet and programmed physical activity.
Arm Title
Lifestyle modification
Arm Type
Experimental
Arm Description
Obtaining ideal body weight by calorie restriction diet and programmed physical activity.
Intervention Type
Drug
Intervention Name(s)
Pentoxifylline
Intervention Description
Pentoxifylline 600 mg BD
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle modification
Intervention Description
obtaining ideal body weight by calorie restriction diet and programmed physical activity.
Primary Outcome Measure Information:
Title
Change from baseline serum alanine aminotransferase at 6 months
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change from baseline serum aspartate aminotransferase at 6 months
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raika Jamali, M.D.
Organizational Affiliation
Tehran University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gastroenterology clinic, Sina Hospital
City
Tehran
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Learn more about this trial
The Effect of Pentoxifylline on Liver Function Tests in Fatty Liver Disease
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