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Non-alcoholic Fatty Liver Disease (NAFLD) in HIV: The Role of Nutritional Interventions

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by University Health Network, Toronto.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Ontario HIV Treatment Network
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00152815
First received: September 7, 2005
Last updated: January 22, 2010
Last verified: January 2010
History of Changes
  Purpose

The purpose of this study is to evaluate the effect of a one-year nutritional intervention with either betaine or vitamin E supplementation, or a weight reducing diet and exercise program on liver steatosis and steatohepatitis.


Condition Intervention Phase
HIV Infections
Fatty Liver
 Drug: antioxidant vitamin E
Behavioral: weight reduction and exercise
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Non-alcoholic Fatty Liver Disease (NAFLD) in HIV: The Role of Nutritional Interventions

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • The change in grading of inflammation assessed by liver biopsy from month 0 to month 12 of the study [ Time Frame: month 0 and month 12 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Liver histology for steatosis and fibrosis staging [ Time Frame: month 0 and month 12 ] [ Designated as safety issue: Yes ]
  • Liver immuno-histochemistry for adducts of MDA: a product of LP [ Time Frame: month 0 and month 12 ] [ Designated as safety issue: Yes ]
  • Alpha-smooth muscle actin (alpha-SMA): a marker of hepatic stellate cell activation [ Time Frame: month 0 and month 12 ] [ Designated as safety issue: Yes ]
  • Transforming growth factor (TGF-beta): a pro-fibrogenic cytokine involved in fibrogenesis [ Time Frame: month 0 and month 12 ] [ Designated as safety issue: Yes ]
  • Liver lipid peroxides and TNP-alpha [ Time Frame: month 0, month 6 and month 12 ] [ Designated as safety issue: Yes ]
  • Liver steatosis and volume will be assessed by ultrasound [ Time Frame: month 0 and month 12 ] [ Designated as safety issue: Yes ]
  • Liver enzymes and IR (HOMA and QUICKLY) will also be measured [ Time Frame: month 0, month 6 and month 12 ] [ Designated as safety issue: Yes ]
  • INF-alpha [ Time Frame: month 0, month 6 and month 12 ] [ Designated as safety issue: Yes ]
  • Lipid peroxide, vitamin E and C will aslo be measured in the plasma [ Time Frame: month 0, month 6 and month 12 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: October 2003
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: antioxidant vitamin E
    Vitamin E 800IU per day for 12 months
    Behavioral: weight reduction and exercise
    Patients will be asked to consume a self-selected, low fat, low-calorie diet of approximately 1200 kcal/d, which is consistent with American Heart Association guidelines for healthy weight reduction. Subjects will be provided with a videotape involving a structured 20 min aerobic exercise to be performed 3x/week.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Baseline liver biopsy with macrovesicular fatty degeneration with inflammation (lobular or portal), with or without Mallory bodies, hepatocyte damage, and/or fibrosis diagnostic of NAFLD
  • Convincing evidence of negligible alcohol consumption (< 20 grams of ethanol per day) obtained from a detailed history, confirmed by at least one close relative
  • If hyperlipidemia or diabetes, stable drug regimen required for the 6 months prior to and during the study
  • Willingness to maintain stable weight and normal exercise program for the duration of the study, if randomized to vitamin E or betaine

Exclusion Criteria:

  • Liver disease of other etiology diagnosed as per routine medical investigation (e.g., chronic viral hepatitis, auto-immune chronic hepatitis, primary biliary cirrhosis or genetic liver disease such as Wilson's disease, hemochromatosis, alpha-1 antitrypsin deficiency, or biliary obstruction)
  • Complications of liver disease such as recurrent variceal bleeding, resistant ascites, spontaneous portosystemic encephalopathy, or bacterial peritonitis
  • Concurrent medical illness contra-indicating a liver biopsy, history of unexplained bleeding, hemophilia or abnormal coagulation results as per routine laboratory work-up or other reason judged by the hepatologist to contra-indicate a percutaneous liver biopsy
  • Medications known to precipitate steatohepatitis (corticosteroids, high dose estrogens, methotrexate, amiodarone, calcium channel blockers, spironolactone, sulfasalazine, naproxen, oxacillin or ampinovire) in the 6 months prior to entry
  • Antioxidant vitamin supplementation, ursodeoxycholic acid, or any other experimental drug 6 months prior to study entry
  • Pregnant or lactating
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00152815

Contacts
Contact: Gail Fernandes, BSc 416-340-4104 gfernand@uhnresearch.ca
Contact: Bianca M Arendt, PhD 416-340-4104 barendt@uhnresearch.ca

Locations
Canada, Ontario
University Health Network, Toronto General Hospital Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Bianca Arendt, PhD, RD     416-340-4104     barendt@uhnresearch.ca    
Sponsors and Collaborators
University Health Network, Toronto
Ontario HIV Treatment Network
Investigators
Principal Investigator: Allard Johane, MD, FRCPC University Health Network, Toronto General Hospital
  More Information

No publications provided

Responsible Party: Dr. Johane Allard, Toronto General Hospital
ClinicalTrials.gov Identifier: NCT00152815     History of Changes
Other Study ID Numbers: 03-0297-B, ROGB139
Study First Received: September 7, 2005
Last Updated: January 22, 2010
Health Authority: Canada: Ethics Review Committee

Keywords provided by University Health Network, Toronto:
HIV
non-alcoholic fatty liver disease

Additional relevant MeSH terms:
Fatty Liver
HIV Infections
Acquired Immunodeficiency Syndrome
Liver Diseases
Food Habits
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
 Digestive System Diseases
Habits
Antioxidants
Vitamin E
Alpha-Tocopherol
Tocopherols
Tocotrienols
Vitamins
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 21, 2013