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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

Tracking Information
First Submitted Date  ICMJE April 9, 2019
First Posted Date  ICMJE April 12, 2019
Last Update Posted Date July 25, 2019
Actual Study Start Date  ICMJE May 21, 2019
Estimated Primary Completion Date April 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03913351 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 16, 2019)
  • 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.
  • Changes in adiposity [ Time Frame: 12 months ]
    The changes in visceral fat will be determined by magnetic resonance imaging at the same session
  • Change in liver fibrosis [ Time Frame: 12 months ]
    The changes in liver fibrosis will be determined by transient elastography by Fibroscan
  • Metabolic endpoints [ Time Frame: 12 months ]
    The proportion of patients with impaired fasting glucose will be determined
  • Metabolic endpoints [ Time Frame: 12 months ]
    The proportion of patients with diabetes will be determined
  • Metabolic endpoints [ Time Frame: 12 months ]
    The proportion of patients with insulin resistance (estimated by the homeostasis model) will be determined
  • Metabolic endpoints [ Time Frame: 12 months ]
    The proportion of patients with hypertension will be determined
  • Metabolic endpoints [ Time Frame: 12 months ]
    The proportion of patients with dyslipidemia will be determined
  • Metabolic endpoints [ Time Frame: 12 months ]
    The proportion of patients with metabolic syndrome will be determined
  • Biomarkers of inflammation and monocyte activation [ Time Frame: 12 months ]
    Changes from baseline in adipokines (adiponectin and leptin)
  • Biomarkers of inflammation and monocyte activation [ Time Frame: 12 months ]
    Changes from baseline in marker of endothelial cell activation (ICAM-1)
  • Biomarkers of inflammation and monocyte activation [ Time Frame: 12 months ]
    Changes from baseline in marker of monocyte activation (sCD163)
Original Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2019)
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lifestyle Modification Programme for HIV-infected Individuals With Fatty Liver
Official Title  ICMJE Lifestyle Modification Programme for HIV-infected Individuals With Non-alcoholic Fatty Liver Disease: A Randomized Controlled Trial
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • NAFLD
  • Hiv
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Lifestyle modification
  • No Intervention: Control
    standard care of treatment, as in routine clinical practice
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 10, 2019)
96
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2022
Estimated Primary Completion Date April 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Vivian Wong +85259621224 vivianwong@cuhk.edu.hk
Contact: Grace Lui +85235051464 gracelui@cuhk.edu.hk
Listed Location Countries  ICMJE Hong Kong
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03913351
Other Study ID Numbers  ICMJE Study Protocol LSM V2
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Grace Lui, Chinese University of Hong Kong
Study Sponsor  ICMJE Chinese University of Hong Kong
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Chinese University of Hong Kong
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP