Screening of NASH in Oupatients Followed in Various Hospital Specialty Clinics at the University Hospital of Strasbourg

NCT ID: NCT04282447

Last Updated: 2020-08-27

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

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-14

Study Completion Date

2022-05-31

Brief Summary

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The aim of the present study is to assess, by using a simple algorithm combining FIB-4 and Fibroscan, the prevalence of NASH with advanced fibrosis in outpatients followed in various hospital specialty clinics other than hepato/gastroenterology and to examine risk factors associated with this condition. The prevalence of NASH will be investigated among 6 cohorts of outpatients followed in different hospital specialty clinics at Hôpitaux Universitaires de Strasbourg.

Detailed Description

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Conditions

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Nonalcoholic Fatty Liver Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* age ≥ 18 years
* outpatients followed at specialty clinics in HUS and at risk of NAFLD: with at least one metabolic risk factor (overweight, diabetes mellitus, hypertension, hypertriglyceridemia) and/or elevated transaminases and/or liver steatosis on US.
* endocrinology cohort : type 2 diabetes patients
* infectious disease cohort : HIV positive patients
* rheumatology cohort : patients with psoriasis, gout or rheumatoid arthritis
* nephrology cohort : patients with chronic kidney disease such as diabetic nephropathy or hypertensive nephropathy, including those receiving hemodialysis.
* cardiology cohorts: patients with history of angina, myocardial infarction, stroke or arteritis of lower limbs.
* internal medicine cohort: patients with auto immune systemic diseases such as lupus, sclerosis or rheumatoid arthritis.
* subjects who have given their informed consent
* Subjects affiliated to a social security system

Exclusion Criteria

* alcohol consumption \> 30g/d in male or \> 20g/d in female in the past 6 months
* history of chronic viral hepatitis
* history of liver auto immune disease, genetic hemochromatosis, Wilson disease
* biliary disease, bile duct obstruction
* drug-induced liver injury
* secondary liver cancer or other active cancer
* organ graft
* use of medications associated with secondary NAFLD (corticosteroids, tamoxifen, amiodarone, methotrexate).
* congestive heart failure
* AIDS
* pregnancy, breastfeeding
* no information could be given to the patient (subject faces emergency situation, comprehension difficulties, etc.)
* patient under guardianship
* patients under judicial protection
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Les Hôpitaux Universitaires de Strasbourg

Strasbourg, , France

Site Status RECRUITING

Countries

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France

Facility Contacts

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Lawrence SERFATY

Role: primary

+33 3 88 12 88 02

Other Identifiers

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7376

Identifier Type: -

Identifier Source: org_study_id

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