Clinical trial NCT04282447: Screening of NASH in Oupatients Followed in Various Hospital Specialty Clinics at the University Hospital of Strasbourg
Official title: Screening of NASH in Oupatients Followed in Various Hospital Specialty Clinics at the University Hospital of Strasbourg
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nonalcoholic Fatty Liver Disease
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2020-02-24
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Estimated prevalence of NASH with advanced fibrosis among several hospital specialty clinics
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Les Hôpitaux Universitaires de Strasbourg
Study officials:
References: