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Lifestyle Modification Programme for HIV-infected Individuals With Fatty Liver

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ClinicalTrials.gov Identifier: NCT03913351
Recruitment Status : Recruiting
First Posted : April 12, 2019
Last Update Posted : July 25, 2019
Sponsor:
Information provided by (Responsible Party):
Grace Lui, Chinese University of Hong Kong

Study Description
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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.


Condition or disease Intervention/treatment Phase
NAFLD Hiv Behavioral: Lifestyle modification Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Lifestyle Modification Programme for HIV-infected Individuals With Non-alcoholic Fatty Liver Disease: A Randomized Controlled Trial
Actual Study Start Date : May 21, 2019
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Resolution of NAFLD [ Time Frame: 12 months ]
    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 :
  1. Partial resolution of NAFLD [ Time Frame: 12 months ]
    Partial resolution of NAFLD is defined as absolute reduction of hepatic triglyceride content by 30% or more.

  2. Changes in adiposity [ Time Frame: 12 months ]
    The changes in visceral fat will be determined by magnetic resonance imaging at the same session

  3. Change in liver fibrosis [ Time Frame: 12 months ]
    The changes in liver fibrosis will be determined by transient elastography by Fibroscan

  4. Metabolic endpoints [ Time Frame: 12 months ]
    The proportion of patients with impaired fasting glucose will be determined

  5. Metabolic endpoints [ Time Frame: 12 months ]
    The proportion of patients with diabetes will be determined

  6. Metabolic endpoints [ Time Frame: 12 months ]
    The proportion of patients with insulin resistance (estimated by the homeostasis model) will be determined

  7. Metabolic endpoints [ Time Frame: 12 months ]
    The proportion of patients with hypertension will be determined

  8. Metabolic endpoints [ Time Frame: 12 months ]
    The proportion of patients with dyslipidemia will be determined

  9. Metabolic endpoints [ Time Frame: 12 months ]
    The proportion of patients with metabolic syndrome will be determined

  10. Biomarkers of inflammation and monocyte activation [ Time Frame: 12 months ]
    Changes from baseline in adipokines (adiponectin and leptin)

  11. Biomarkers of inflammation and monocyte activation [ Time Frame: 12 months ]
    Changes from baseline in marker of endothelial cell activation (ICAM-1)

  12. Biomarkers of inflammation and monocyte activation [ Time Frame: 12 months ]
    Changes from baseline in marker of monocyte activation (sCD163)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03913351


Contacts
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Contact: Vivian Wong +85259621224 vivianwong@cuhk.edu.hk
Contact: Grace Lui +85235051464 gracelui@cuhk.edu.hk

Locations
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Hong Kong
Prince of Wales Hospital Recruiting
Shatin, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong
More Information
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Responsible Party: Grace Lui, Clinical Assistant Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT03913351     History of Changes
Other Study ID Numbers: Study Protocol LSM V2
First Posted: April 12, 2019    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fatty Liver
Liver Diseases
Digestive System Diseases