Lifestyle Modification Programme for HIV-infected Individuals With Fatty Liver
Primary Purpose
NAFLD, Hiv
Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Lifestyle modification
Sponsored by
About this trial
This is an interventional treatment trial for NAFLD
Eligibility Criteria
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).
Sites / Locations
- Prince of Wales HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Lifestyle modification program
Control
Arm Description
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.
standard care of treatment, as in routine clinical practice
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Partial resolution of NAFLD
Partial resolution of NAFLD is defined as absolute reduction of hepatic triglyceride content by 30% or more.
Changes in adiposity
The changes in visceral fat will be determined by magnetic resonance imaging at the same session
Change in liver fibrosis
The changes in liver fibrosis will be determined by transient elastography by Fibroscan
Metabolic endpoints
The proportion of patients with impaired fasting glucose will be determined
Metabolic endpoints
The proportion of patients with diabetes will be determined
Metabolic endpoints
The proportion of patients with insulin resistance (estimated by the homeostasis model) will be determined
Metabolic endpoints
The proportion of patients with hypertension will be determined
Metabolic endpoints
The proportion of patients with dyslipidemia will be determined
Metabolic endpoints
The proportion of patients with metabolic syndrome will be determined
Biomarkers of inflammation and monocyte activation
Changes from baseline in adipokines (adiponectin and leptin)
Biomarkers of inflammation and monocyte activation
Changes from baseline in marker of endothelial cell activation (ICAM-1)
Biomarkers of inflammation and monocyte activation
Changes from baseline in marker of monocyte activation (sCD163)
Full Information
NCT ID
NCT03913351
First Posted
April 9, 2019
Last Updated
August 28, 2023
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT03913351
Brief Title
Lifestyle Modification Programme for HIV-infected Individuals With Fatty Liver
Official Title
Lifestyle Modification Programme for HIV-infected Individuals With Non-alcoholic Fatty Liver Disease: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 21, 2019 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NAFLD, Hiv
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lifestyle modification program
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
standard care of treatment, as in routine clinical practice
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle modification
Intervention Description
The program consists of education on glycemic index, balanced diet, interpretation of food labels, food exchanges, healthy eating out techniques and healthy cooking methods.
Primary Outcome Measure Information:
Title
Resolution of NAFLD
Description
The primary endpoint is the proportion of patients with resolution of NAFLD as determined by proton-magnetic resonance spectroscopy at month 12.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Partial resolution of NAFLD
Description
Partial resolution of NAFLD is defined as absolute reduction of hepatic triglyceride content by 30% or more.
Time Frame
12 months
Title
Changes in adiposity
Description
The changes in visceral fat will be determined by magnetic resonance imaging at the same session
Time Frame
12 months
Title
Change in liver fibrosis
Description
The changes in liver fibrosis will be determined by transient elastography by Fibroscan
Time Frame
12 months
Title
Metabolic endpoints
Description
The proportion of patients with impaired fasting glucose will be determined
Time Frame
12 months
Title
Metabolic endpoints
Description
The proportion of patients with diabetes will be determined
Time Frame
12 months
Title
Metabolic endpoints
Description
The proportion of patients with insulin resistance (estimated by the homeostasis model) will be determined
Time Frame
12 months
Title
Metabolic endpoints
Description
The proportion of patients with hypertension will be determined
Time Frame
12 months
Title
Metabolic endpoints
Description
The proportion of patients with dyslipidemia will be determined
Time Frame
12 months
Title
Metabolic endpoints
Description
The proportion of patients with metabolic syndrome will be determined
Time Frame
12 months
Title
Biomarkers of inflammation and monocyte activation
Description
Changes from baseline in adipokines (adiponectin and leptin)
Time Frame
12 months
Title
Biomarkers of inflammation and monocyte activation
Description
Changes from baseline in marker of endothelial cell activation (ICAM-1)
Time Frame
12 months
Title
Biomarkers of inflammation and monocyte activation
Description
Changes from baseline in marker of monocyte activation (sCD163)
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vivian Wong
Phone
+85259621224
Email
vivianwong@cuhk.edu.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Grace Lui
Phone
+85235051464
Email
gracelui@cuhk.edu.hk
Facility Information:
Facility Name
Prince of Wales Hospital
City
Shatin
Country
Hong Kong
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Lifestyle Modification Programme for HIV-infected Individuals With Fatty Liver
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