Obstructive Sleep Apnea and Non-alcoholic Fatty Liver Disease (NASHSAS)
Primary Purpose
Non-alcoholic Fatty Liver Disease, Sleep Apnea, Obstructive
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
OSA screening
Sponsored by
About this trial
This is an interventional screening trial for Non-alcoholic Fatty Liver Disease
Eligibility Criteria
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
Sites / Locations
- CHU AngersRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patient suspected for NAFLD
Arm Description
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT03373643
First Posted
November 13, 2017
Last Updated
January 15, 2019
Sponsor
University Hospital, Angers
1. Study Identification
Unique Protocol Identification Number
NCT03373643
Brief Title
Obstructive Sleep Apnea and Non-alcoholic Fatty Liver Disease
Acronym
NASHSAS
Official Title
Association Between Obstructive Sleep Apnea and Non-alcoholic Fatty Liver Disease Investigated by Liver Biopsy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 14, 2017 (Actual)
Primary Completion Date
December 14, 2019 (Anticipated)
Study Completion Date
March 14, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-alcoholic Fatty Liver Disease, Sleep Apnea, Obstructive
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patient suspected for NAFLD
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
OSA screening
Intervention Description
Full night polysomnography
Primary Outcome Measure Information:
Title
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)
Description
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).
Time Frame
The polysomnography will be performed no more than 3 months after the liver biopsy.
Secondary Outcome Measure Information:
Title
Association between OSA severity marker (apnea hypopnea index per hour on the polysomnography) and significant nonalcoholic steatohepatitis (3 positive criteria on NASH-CRN classification)
Description
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.
Time Frame
The polysomnography will be performed no more than 3 months after the liver biopsy.
Title
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)
Description
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.
Time Frame
The polysomnography will be performed no more than 3 months after the liver biopsy.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CHU Angers
City
Angers
State/Province
Please Select
ZIP/Postal Code
49100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wojciech Trzepizur, MD PhD
Phone
680575272
Ext
+33
Email
wotrzepizur@chu-angers.fr
First Name & Middle Initial & Last Name & Degree
Jérôme Boursier, MD PhD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Obstructive Sleep Apnea and Non-alcoholic Fatty Liver Disease
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