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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00152815
• Other study ID #: 03-0297-B
• Secondary ID: ROGB139
• Status: Terminated
• Phase: Phase 2
• First received: September 7, 2005
• Last updated: July 17, 2013
• Start date: October 2003
• Est. completion date: December 2010

Study information

• Verified date: July 2013
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatty Liver
• HIV Infections
• Liver Diseases

Intervention

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.

Locations

Country	Name	City	State
Canada	University Health Network, Toronto General Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Johane Allard	Ontario HIV Treatment Network

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in grading of inflammation assessed by liver biopsy from month 0 to month 12 of the study		month 0 and month 12	No
Secondary	Liver histology for steatosis and fibrosis staging		month 0 and month 12	No
Secondary	Liver immuno-histochemistry for adducts of MDA: a product of LP		month 0 and month 12	No
Secondary	Alpha-smooth muscle actin (alpha-SMA): a marker of hepatic stellate cell activation		month 0 and month 12	No
Secondary	Transforming growth factor (TGF-beta): a pro-fibrogenic cytokine involved in fibrogenesis		month 0 and month 12	No
Secondary	Liver lipid peroxides and TNP-alpha	For oxidative stress and inflammation in the liver	month 0, month 6 and month 12	No
Secondary	Liver steatosis and volume will be assessed by ultrasound		month 0 and month 12	Yes
Secondary	Liver enzymes and IR (HOMA and QUICKY) will also be measured		month 0, month 6 and month 12	Yes
Secondary	Lipid peroxides, TNF-alpha, vitamin E and C in plasma	Parameters for oxidative stress and antioxidant capacity	month 0, month 6 and month 12	No