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Screening of NASH in Oupatients Followed in Various Hospital Specialty Clinics at the University Hospital of Strasbourg (NASH-SPE)

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ClinicalTrials.gov Identifier: NCT04282447
Recruitment Status : Not yet recruiting
First Posted : February 24, 2020
Last Update Posted : February 24, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

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.

Condition or disease
Nonalcoholic Fatty Liver Disease

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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Screening of NASH in Oupatients Followed in Various Hospital Specialty Clinics at the University Hospital of Strasbourg
Estimated Study Start Date : February 2020
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : May 2022





Primary Outcome Measures :
  1. Estimated prevalence of NASH with advanced fibrosis among several hospital specialty clinics [ Time Frame: 3 months ]
    To assess the estimated prevalence of NASH with advanced fibrosis among several hospital specialty clinics by using the combination of FIB4 and fibroscan in outpatients at risk of NAFLD with no excessive alcohol consumption or viral hepatitis followed in endocrinology, cardiology, internal medicine, rheumatology, nephrology and infectious disease.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04282447


Locations
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France
Les Hôpitaux Universitaires de Strasbourg
Strasbourg, France, 67091
Contact: Lawrence SERFATY    +33 3 88 12 88 02    Lawrence.serfaty@chru-strasbourg.fr   
Principal Investigator: Laurence SERFATY         
Sub-Investigator: Camille BESCH         
Sub-Investigator: Gérald ROUL         
Sub-Investigator: Jacques-Eric GOTTENBERG         
Sub-Investigator: Emmanuel CHATELUS         
Sub-Investigator: David REY         
Sub-Investigator: Bruno MOULIN         
Sponsors and Collaborators
University Hospital, Strasbourg, France
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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT04282447    
Other Study ID Numbers: 7376
First Posted: February 24, 2020    Key Record Dates
Last Update Posted: February 24, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases