Clincosm LogoSign in Get a demo

Prevalence of Non-alcoholic Fatty Liver Disease Among Non-obese Obstructive Sleep Apnea by Using Transient Elastography

Sponsor
Chinese University of Hong Kong (Other)
Overall Status
Recruiting
CT.gov ID
NCT05351515
Collaborator
(none)
1,000
Enrollment
1
Location
33.1
Anticipated Duration (Months)
30.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Obstructive sleep apnea (OSA) and non-alcoholic fatty liver disease (NAFLD) are both common diseases related to metabolic diseases with potential cardiovascular consequences and liver complications respectively. Though studies show OSA may take part in the progression of hepatic steatosis, the independent contribution of OSA on liver fat accumulation is unknown. It is hypothesized that nocturnal intermittent hypoxia from OSA is the main driver of NAFLD in non-obese OSA patients. This study is to assess the effect of OSA on NAFLD in non-obese patients.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    Prevalence of Non-alcoholic Fatty Liver Disease Among Non-obese Obstructive Sleep Apnea by Using Transient Elastography
    Actual Study Start Date :
    Apr 30, 2022
    Anticipated Primary Completion Date :
    Jan 31, 2025
    Anticipated Study Completion Date :
    Jan 31, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Number of subjects found to have fatty liver disease among obese patients with obstructive sleep apnea [baseline]

    2. Number of subjects found to have fatty liver disease among non-obese patients with obstructive sleep apnea [baseline]

    Secondary Outcome Measures

    1. Number of subjects found to have fatty liver disease among obese subjects without obstructive sleep apnea [baseline]

    2. Number of subjects found to have fatty liver disease among non-obese subjects without obstructive sleep apnea [baseline]

    3. mesenteric fat thickness by ultrasound scan of all subjects [baseline]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • aged 18 years or more
    Exclusion Criteria:

    • underlying cause of liver disease

    • history of excessive alcoholic consumption (more than 30 g/day for men and 20 g/day for women)

    • secondary causes of hepatic steatosis (such as chronic use of systemic corticosteroids)

    • positive hepatitis B surface antigen, anti-hepatitis C virus antibody, or histological evidence of other concomitant chronic liver diseases.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chinese University of Hong Kong Hong Kong Hong Kong

    Sponsors and Collaborators

    • Chinese University of Hong Kong

    Investigators

    • Study Chair: David Hui, Chinese University of Hong Kong

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Prof David Shu Cheong Hui, Professor, Chinese University of Hong Kong
    ClinicalTrials.gov Identifier:
    NCT05351515
    Other Study ID Numbers:
    • OSA-fattyliver2
    First Posted:
    Apr 28, 2022
    Last Update Posted:
    May 27, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Liver Diseases
    Fatty Liver
    Non-alcoholic Fatty Liver Disease
    Apnea
    Sleep Apnea Syndromes
    Sleep Apnea, Obstructive

    Study Results

    No Results Posted as of May 27, 2022