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

Nonalcoholic Fatty Liver Disease Clinical Trial

— NASH-SPE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04282447
• Other study ID #: 7376
• Status: Recruiting
• Start date: August 14, 2020
• Est. completion date: May 2022

Study information

• Verified date: February 2020
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: May 2022
• Est. primary completion date: August 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease
• Nonalcoholic Fatty Liver Disease

Locations

Country	Name	City	State
France	Les Hôpitaux Universitaires de Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimated prevalence of NASH with advanced fibrosis among several hospital specialty clinics	To assess the estimated prevalence of NASH , calcul of the FIB4	3 months