Non-alcoholic Fatty Liver Disease, Sleep Apnea, Obstructive
Conditions
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.
Interventions
DIAGNOSTIC_TESTOSA screening
Full night polysomnography
Sponsors
University Hospital, Angers
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
France
Outcome results
None listed