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

August 25, 2020 updated by: University Hospital, Strasbourg, France
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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Strasbourg, France, 67091
        • Recruiting
        • Les Hôpitaux Universitaires de Strasbourg
        • Sub-Investigator:
          • Camille BESCH
        • Contact:
        • Principal Investigator:
          • Laurence SERFATY
        • Sub-Investigator:
          • Gérald ROUL
        • Sub-Investigator:
          • Jacques-Eric GOTTENBERG
        • Sub-Investigator:
          • Emmanuel CHATELUS
        • Sub-Investigator:
          • David REY
        • Sub-Investigator:
          • Bruno MOULIN
        • Sub-Investigator:
          • Laurence KESSLER
        • Sub-Investigator:
          • Thibault BAHOUGNE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimated prevalence of NASH with advanced fibrosis among several hospital specialty clinics
Time Frame: 3 months
To assess the estimated prevalence of NASH , calcul of the FIB4
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 14, 2020

Primary Completion (Actual)

August 14, 2020

Study Completion (Anticipated)

May 1, 2022

Study Registration Dates

First Submitted

February 21, 2020

First Submitted That Met QC Criteria

February 21, 2020

First Posted (Actual)

February 24, 2020

Study Record Updates

Last Update Posted (Actual)

August 27, 2020

Last Update Submitted That Met QC Criteria

August 25, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7376

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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