Clinical trial NCT04435054: Screening for NAFLD-related Advanced Fibrosis in High Risk Population in Diabetology.
Official title: Screening for NAFLD-related Advanced Fibrosis in High Risk popuLation: Optimization of the Diabetology Pathway Referral Using Combinations of Non-invAsive Biological and elastogRaphy paramEters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-Alcoholic Fatty Liver Disease
Keywords: NAFLD
Type 2 diabete
Obesity
Advanced fibrosis
Cirrhosis
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-06-17
Enrollment: 1000
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Nonalcoholic fatty liver disease (NAFLD) is being recognized as one of the most prevalent causes of chronic liver disease worldwide. The current strategy proposed by the EASL/EASO/EASD European guidelines for the screening of nonalcoholic fatty liver disease (NAFLD) in high-risk population such as type 2 diabetes and patients with obesity leads to an over-referral in hepatology clinics. The proposed study will investigate the optimal strategy for the screening of NAFLD-related advanced fibrosis in patients at high risk of fibrotic NAFLD, such as patients with T2DM or obesity by maximizing the positive predictive value (PPV) using non-invasive blood and elastography-based biomarkers in endocrinology/diabetology clinics in order to reduce the over-referral to hepatology clinics.


Eligibility criteria: Inclusion Criteria:

* Patient aged between 40 and 80 years old,
* Patients with diagnosis of T2DM\* or obesity (defined according to World Health Organization as a BMI≥ 30 kg/m2)
* Patient with hepatic steatosis determined by conventional abdominal ultrasound as defined by the EASL/EASO/EASD European guidelines.
* Patient who agrees to be included in the study and who signs the informed consent form,
* Patient affiliated to a healthcare insurance plan.

Exclusion Criteria:

* Evidence of other causes of chronic liver disease:
* History of ingestion of medications known to produce steatosis in the previous 6 months.
* Evidence of cirrhosis or previously known cirrhosis based on the results from previous liver biopsy or history of portal hypertension presented by ascites, hepatic encephalopathy or varices
* Presence of regular and/or excessive use of alcohol (defined as \>30g/day for males and \>15g/day for females) for a period longer than 2 years at any times in the last 10 years
* The subject is a pregnant or nursing female
* Life expectancy less than 5 years
* History of known HIV infection
* History of type 1 diabete
* BMI ≥ 40 kg/m2
* Mentally unbalanced patients, under supervision or guardianship,
* Patient deprived of liberty,
* Patient who does not understand French/ is unable to give consent,
* Patient already included in a trial who may interfere with the study or in a period of exclusion following participation in a previous study.

Primary outcomes:
measure: Presence of individual F0 to F4 stage of fibrosis
timeFrame: 6 months
Secondary outcomes:
measure: Fibroscan
timeFrame: 6 months
Other outcomes:
Locations:
city: Dijon
country: France
facility: Centre Hospitalier Universitaire Dijon Bourgogne
city: Nantes
country: France
facility: CHU de Nantes
city: Pierre-Bénite
country: France
facility: Hôpital Lyon Sud
Study officials:
affiliation: Hospices Civils de Lyon
name: Cyrielle CAUSSY, MD
role: PRINCIPAL_INVESTIGATOR
References: