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

NCT00152815 | Terminated Phase 2

• 2 other identifiers: 03-0297-BROGB139
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections; Fatty Liver

Keywords

HIV; non-alcoholic fatty liver disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

Study Arms (1)

Vitamin E

EXPERIMENTAL

alpha-tocoperol, capsules, 2 per day

Drug: antioxidant vitamin E; Behavioral: weight reduction and exercise

Interventions

antioxidant vitamin E DRUG

Vitamin E 800IU per day for 12 months

Vitamin E

weight reduction and exercise BEHAVIORAL

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.

Also known as: This arm was removed from the study protocol, as the enrollment was slow and, a high drop-out rate was observed in the weigh-loss arm

Vitamin E

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johane Allard: lead
• Ontario HIV Treatment Network: collaborator

Study Sites (1)

University Health Network, Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Conditions

HIV Infections; Fatty Liver; Non-alcoholic Fatty Liver Disease

Interventions

Exercise

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Allard Johane, MD, FRCPC

  University Health Network, Toronto General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Gastroenterologist, Professor of Medicine

Study Record Dates

• First Submitted: September 7, 2005
• First Posted: September 9, 2005
• Study Start: October 1, 2003
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: July 19, 2013

Record last verified: 2013-07

Locations

CA (1)