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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05351515
Other study ID # OSA-fattyliver2
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 30, 2022
Est. completion date January 31, 2025

Study information

Verified date August 2023
Source Chinese University of Hong Kong
Contact Ken KP Chan
Phone +852 35052211
Email chankapang@cuhk.edu.hk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date January 31, 2025
Est. primary completion date January 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Hong Kong Chinese University of Hong Kong Hong Kong

Sponsors (1)

Lead Sponsor Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of subjects found to have fatty liver disease among obese patients with obstructive sleep apnea baseline
Primary Number of subjects found to have fatty liver disease among non-obese patients with obstructive sleep apnea baseline
Secondary Number of subjects found to have fatty liver disease among obese subjects without obstructive sleep apnea baseline
Secondary Number of subjects found to have fatty liver disease among non-obese subjects without obstructive sleep apnea baseline
Secondary mesenteric fat thickness by ultrasound scan of all subjects baseline
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