Obstructive Sleep Apnea and Non-alcoholic Fatty Liver Disease

Non-alcoholic Fatty Liver Disease Clinical Trial

— NASHSAS  

Official title:

Association Between Obstructive Sleep Apnea and Non-alcoholic Fatty Liver Disease Investigated by Liver Biopsy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03373643
• Other study ID #: UHAngers
• Status: Recruiting
• Phase: N/A
• Start date: December 14, 2017
• Est. completion date: March 14, 2020

Study information

• Verified date: January 2019
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 14, 2020
• Est. primary completion date: December 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Diagnostic Test:
• OSA screening
Full night polysomnography

Locations

Country	Name	City	State
France	CHU Angers	Angers	Please Select

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	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).	The polysomnography will be performed no more than 3 months after the liver biopsy.
Secondary	Association between OSA severity marker (apnea hypopnea index per hour on the polysomnography) and significant nonalcoholic steatohepatitis (3 positive criteria on NASH-CRN classification)	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.	The polysomnography will be performed no more than 3 months after the liver biopsy.
Secondary	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)	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.	The polysomnography will be performed no more than 3 months after the liver biopsy.