Fatty Liver, HIV Infections
Conditions
Keywords
HIV, non-alcoholic fatty liver disease
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.
Interventions
DRUGantioxidant vitamin E
Vitamin E 800IU per day for 12 months
BEHAVIORALweight 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.
Sponsors
Ontario HIV Treatment Network
Johane Allard
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 histology for steatosis and fibrosis staging | month 0 and month 12 | — |
| 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 |
| Liver lipid peroxides and TNP-alpha | month 0, month 6 and month 12 | For oxidative stress and inflammation in the liver |
Countries
Canada
Outcome results
None listed