Obstructive Sleep Apnea and Non-alcoholic Fatty Liver Disease

Not Applicable

• Conditions: Non-alcoholic Fatty Liver Disease; Sleep Apnea, Obstructive
• Interventions: Diagnostic Test: OSA screening

• Registration Number: NCT03373643
• Lead Sponsor: University Hospital, Angers

Brief Summary

Obstructive sleep apnea (OSA) and nonalcoholic fatty liver disease (NAFLD) are frequently encountered in patients with metabolic syndrome (MS). Several data suggest that OSA per se could be a risk factor of liver injury. Most previous studies evaluating the association between OSA severity and the severity of NAFLD used indirect markers of NAFLD including liver imaging or liver injury blood markers or have been performed in morbidly obese patients undergoing intraoperative needle liver biopsy during bariatric surgery.

The current study propose to investigate with a full night polysomnography consecutive patients undergoing percutaneous liver biopsy for suspected NAFLD.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-13
• Study First Submitted QC: 2017-12-13
• Study Start: 2017-12-14
• Study First Posted: 2017-12-14
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-15
• Last Update Posted: 2019-01-16
• Primary Completion: 2019-12-14
• Study Completion: 2020-03-14

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Suspected NAFLD requiring per-cutaneous liver biopsy

Exclusion Criteria

• Other than NAFLD liver disease
• Previously diagnosed or treated OSA
• Excessive alcohol consumption (>220 gr/week for men, >140 gr/week for women)
• Pregnancy
• Surgical treatment for obesity past history

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patient suspected for NAFLD	OSA screening	-

Primary Outcome Measures

Name	Time	Method
Association between OSA severity marker (apnea hypopnea index per hour on the polysomnography) and significant liver fibrosis (score F3 and F4 of the histological nonalcoholic steatohepatitis [NASH]-CRN classification)	The polysomnography will be performed no more than 3 months after the liver biopsy.	Apnea hypopnea index per hour of sleep is investigated in each participant using full night polysomnography.; Significant liver fibrosis will be considered if histological analysis conclude to a fibrosis score of 3 or more using the NASH-CRN classification (F3 and F4).

Secondary Outcome Measures

Name	Time	Method
Association between OSA severity marker (apnea hypopnea index per hour on the polysomnography) and significant nonalcoholic steatohepatitis (3 positive criteria on NASH-CRN classification)	The polysomnography will be performed no more than 3 months after the liver biopsy.	Apnea hypopnea index per hour of sleep is investigated in each participant using full night polysomnography.; Significant nonalcoholic steatohepatitis will be considered if histological analysis meets 3 positive criteria on NASH-CRN classification: steatosis score ≥ 1 and lobular inflammation score ≥ 1 and hepatocyte ballooning score ≥ 1.
Association between OSA severity marker (apnea hypopnea index per hour on the polysomnography) and significant liver steatosis (histological steatosis > 33% or stade 2 or more on NASH-CRN)	The polysomnography will be performed no more than 3 months after the liver biopsy.	Apnea hypopnea index per hour of sleep is investigated in each participant using full night polysomnography.; Significant liver steatosis will be considered if histological analysis conclude to a histological steatosis of 30% or more or a stade 2 steatosis or more using the NASH-CRN classification.

Trial Locations

Locations (1)

CHU Angers; 🇫🇷 Angers, Please Select, France