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

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ClinicalTrials.gov Identifier: NCT02283710
Recruitment Status : Completed
First Posted : November 5, 2014
Last Update Posted : November 6, 2014
Sponsor:
Information provided by (Responsible Party):
Raika Jamali, MD, Tehran University of Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Fatty Liver Drug: Pentoxifylline Behavioral: Lifestyle modification Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Pentoxifylline on Liver Function Tests in Non-alcoholic Fatty Liver Disease Patients Refereed to Sina Hospital Gastroenterology Clinic
Study Start Date : May 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014


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.




Primary Outcome Measures :
  1. Change from baseline serum alanine aminotransferase at 6 months [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Change from baseline serum aspartate aminotransferase at 6 months [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02283710


Locations
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Iran, Islamic Republic of
Gastroenterology clinic, Sina Hospital
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Tehran University of Medical Sciences
Investigators
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Principal Investigator: Raika Jamali, M.D. Tehran University of Medical Sciences

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Responsible Party: Raika Jamali, MD, Associate Professor of Medicine, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02283710     History of Changes
Other Study ID Numbers: 9011160012
First Posted: November 5, 2014    Key Record Dates
Last Update Posted: November 6, 2014
Last Verified: November 2014

Keywords provided by Raika Jamali, MD, Tehran University of Medical Sciences:
Pentoxifylline
Aminotransferase
Steatohepatitis

Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases
Pentoxifylline
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Vasodilator Agents
Free Radical Scavengers
Antioxidants