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

Sleep Apnea, Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05351515
• Other study ID #: OSA-fattyliver2
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Apnea
• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

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