Obstructive Sleep Apnea and Non-alcoholic Fatty Liver Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-14

Study Completion Date

2020-03-14

Brief Summary

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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.

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Detailed Description

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Conditions

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Non-alcoholic Fatty Liver Disease Sleep Apnea, Obstructive

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Patient suspected for NAFLD

Group Type EXPERIMENTAL

OSA screening

Intervention Type DIAGNOSTIC_TEST

Full night polysomnography

Interventions

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OSA screening

Full night polysomnography

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No