Lifestyle Modification Programme for HIV-infected Individuals With Fatty Liver

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hiv; NAFLD
• Intervention / Treatment: Behavioral: Lifestyle modification

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vivian Wong; Phone Number: +85259621224; Email: vivianwong@cuhk.edu.hk
• Study Contact Backup: Name: Grace Lui; Phone Number: +85235051464; Email: gracelui@cuhk.edu.hk

Study Locations

• Hong Kong
  • Shatin, Hong Kong
    • Recruiting
    • Prince of Wales Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lifestyle modification program; The dietary intervention program will be scheduled for 12 months, and conducted by a dietitian.The program aims to increase energy expenditure and reduce caloric intake, with an emphasis on long-term lifestyle and behavioural change. An exercise instructor will provide advice on physical activity. A mobile tracking device to monitor calories expenditure will be provided to each participant during they study period to encourage physical activity.	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.
No Intervention: Control; standard care of treatment, as in routine clinical practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2019
• Primary Completion (Estimated): December 30, 2023
• Study Completion (Estimated): December 30, 2023

Study Registration Dates

• First Submitted: April 9, 2019
• First Submitted That Met QC Criteria: April 10, 2019
• First Posted (Actual): April 12, 2019

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 28, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver
• Other Study ID Numbers: Study Protocol LSM V2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No