Non-alcoholic Fatty Liver Disease (NAFLD) in HIV: The Role of Nutritional Interventions
Phase 2
Terminated
- Conditions
- HIV InfectionsFatty Liver
- Interventions
- Drug: antioxidant vitamin EBehavioral: weight reduction and exercise
- Registration Number
- NCT00152815
- Lead Sponsor
- Johane Allard
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 30
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Vitamin E antioxidant vitamin E alpha-tocoperol, capsules, 2 per day Vitamin E weight reduction and exercise alpha-tocoperol, capsules, 2 per day
- Primary Outcome Measures
Name Time Method The change in grading of inflammation assessed by liver biopsy from month 0 to month 12 of the study month 0 and month 12
- Secondary Outcome Measures
Name Time Method Liver histology for steatosis and fibrosis staging month 0 and month 12 Liver immuno-histochemistry for adducts of MDA: a product of LP month 0 and month 12 Alpha-smooth muscle actin (alpha-SMA): a marker of hepatic stellate cell activation month 0 and month 12 Transforming growth factor (TGF-beta): a pro-fibrogenic cytokine involved in fibrogenesis month 0 and month 12 Liver lipid peroxides and TNP-alpha month 0, month 6 and month 12 For oxidative stress and inflammation in the liver
Liver steatosis and volume will be assessed by ultrasound month 0 and month 12 Liver enzymes and IR (HOMA and QUICKY) will also be measured month 0, month 6 and month 12 Lipid peroxides, TNF-alpha, vitamin E and C in plasma month 0, month 6 and month 12 Parameters for oxidative stress and antioxidant capacity
Trial Locations
- Locations (1)
University Health Network, Toronto General Hospital
🇨🇦Toronto, Ontario, Canada