Lifestyle Modification Programme for HIV-infected Individuals With Fatty Liver

Hiv Clinical Trial

Official title:

Lifestyle Modification Programme for HIV-infected Individuals With Non-alcoholic Fatty Liver Disease: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03913351
• Other study ID #: Study Protocol LSM V2
• Status: Recruiting
• Phase: N/A
• Start date: May 21, 2019
• Est. completion date: December 30, 2023

Study information

• Verified date: August 2023
• Source: Chinese University of Hong Kong
• Contact: Vivian Wong
• Phone: +85259621224
• Email: vivianwong[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Non-alcoholic fatty liver disease (NAFLD) is rising in prevalence, and will likely become the predominant cause of chronic liver disease in HIV-infected individuals. Metabolic factors and obesity are important risk factors for NAFLD in HIV-infected individuals. There is currently no approved effective pharmacological treatment for fatty liver disease. Therefore, lifestyle modification directing at weight loss is currently the cornerstone of treatment for fatty liver disease in the general population. Hypocaloric diets can improve fatty liver in the general population, but the most effective specific dietary interventions are yet to be elucidated. The study aims to 1. determine the efficacy of a lifestyle modification programme in inducing resolution of NAFLD in HIV-infected individuals 2. to determine the efficacy of a lifestyle modification programme in improving insulin resistance, pro-inflammatory markers, and liver fibrosis in HIV-infected individuals with fatty liver disease 3. to determine changes in intestinal microbiome secondary to the lifestyle modification programme, and the association with resolution of NAFLD in this group of patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age 18 years or above
• positive HIV antibody, on anti-retroviral therapy
• HIV viral load =50 copies/mL for =6 months
• intrahepatic triglyceride content =5% on magnetic resonance spectroscopy

Exclusion Criteria:

• current AIDS-defining illness
• active malignancy, or history of malignancy within the last 5 years
• hepatitis B and/or hepatitis C co-infection, as determined by positive HBsAg and anti--HCV antibody
• alcohol consumption >30g per week in men or 20g per week in women
• alanine aminotransferase (ALT) above 10 times the upper limit of normal
• liver decompensation (as evidenced by bilirubin above 50 µmol/l, platelet count below 100 × 109/l, prothrombin time above 1.3 times the upper limit of normal, albumin below 35 g/l, presence of ascites or varices).

Related Conditions & MeSH terms

• Fatty Liver
• Hiv
• NAFLD

Intervention

Behavioral:
• Lifestyle modification
The program consists of education on glycemic index, balanced diet, interpretation of food labels, food exchanges, healthy eating out techniques and healthy cooking methods.

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Shatin

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resolution of NAFLD	The primary endpoint is the proportion of patients with resolution of NAFLD as determined by proton-magnetic resonance spectroscopy at month 12.	12 months
Secondary	Partial resolution of NAFLD	Partial resolution of NAFLD is defined as absolute reduction of hepatic triglyceride content by 30% or more.	12 months
Secondary	Changes in adiposity	The changes in visceral fat will be determined by magnetic resonance imaging at the same session	12 months
Secondary	Change in liver fibrosis	The changes in liver fibrosis will be determined by transient elastography by Fibroscan	12 months
Secondary	Metabolic endpoints	The proportion of patients with impaired fasting glucose will be determined	12 months
Secondary	Metabolic endpoints	The proportion of patients with diabetes will be determined	12 months
Secondary	Metabolic endpoints	The proportion of patients with insulin resistance (estimated by the homeostasis model) will be determined	12 months
Secondary	Metabolic endpoints	The proportion of patients with hypertension will be determined	12 months
Secondary	Metabolic endpoints	The proportion of patients with dyslipidemia will be determined	12 months
Secondary	Metabolic endpoints	The proportion of patients with metabolic syndrome will be determined	12 months
Secondary	Biomarkers of inflammation and monocyte activation	Changes from baseline in adipokines (adiponectin and leptin)	12 months
Secondary	Biomarkers of inflammation and monocyte activation	Changes from baseline in marker of endothelial cell activation (ICAM-1)	12 months
Secondary	Biomarkers of inflammation and monocyte activation	Changes from baseline in marker of monocyte activation (sCD163)	12 months