Back to resultsScreening for NAFLD-related Advanced Fibrosis in High Risk Population in Diabetology. (NAFLD-CARE)
Primary Purpose
Non-Alcoholic Fatty Liver Disease
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Non-invasive blood-based and imaging-based tests for the screening of NAFLD-related advanced fibrosis.
Sponsored by
About this trial
This is an interventional screening trial for Non-Alcoholic Fatty Liver Disease focused on measuring NAFLD, Type 2 diabete, Obesity, Advanced fibrosis, Cirrhosis
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.
Sites / Locations
- Centre Hospitalier Universitaire Dijon Bourgogne
- CHU de Nantes
- Hôpital Lyon SudRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Non invasive tests
Arm Description
Outcomes
Primary Outcome Measures
Presence of individual F0 to F4 stage of fibrosis
The presence of individual F0 to F4 stage of fibrosis as defined by histological stage in the liver biopsy using the NASH CRN Scoring System.
Secondary Outcome Measures
Fibroscan
The presence of liver stiffness measured using Fibroscan (VCTE) ≥ 7 kPa.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04435054
Brief Title
Screening for NAFLD-related Advanced Fibrosis in High Risk Population in Diabetology.
Acronym
NAFLD-CARE
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
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 28, 2020 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Alcoholic Fatty Liver Disease
Keywords
NAFLD, Type 2 diabete, Obesity, Advanced fibrosis, Cirrhosis
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Non invasive tests
Arm Type
Other
Intervention Type
Diagnostic Test
Intervention Name(s)
Non-invasive blood-based and imaging-based tests for the screening of NAFLD-related advanced fibrosis.
Intervention Description
Non-invasive blood biological tests - NAFLD Fibrosis Score, FIB-4, Fibrotest, FibrometerNAFLD
Non-invasive imaging:
- Transient elastography (FibroScan), Shear Wave imaging, Magnetic resonance imaging (MRI-PDFF and MRE) in a subgroup of participants.
Primary Outcome Measure Information:
Title
Presence of individual F0 to F4 stage of fibrosis
Description
The presence of individual F0 to F4 stage of fibrosis as defined by histological stage in the liver biopsy using the NASH CRN Scoring System.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Fibroscan
Description
The presence of liver stiffness measured using Fibroscan (VCTE) ≥ 7 kPa.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cyrielle CAUSSY, MD
Phone
04 78 86 44 48
Ext
+33
Email
cyrielle.caussy@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Dominique DELAUNAY
Phone
04.72.11.00.64
Ext
+33
Email
Dominique.delaunay@chu-lyon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cyrielle CAUSSY, MD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire Dijon Bourgogne
City
Dijon
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruno Verges, MD, PhD
Phone
03 80 74 08 05
Ext
+33
Email
bruno.verges@chu-dijon.fr
First Name & Middle Initial & Last Name & Degree
Bruno Verges, MD, PhD
Facility Name
CHU de Nantes
City
Nantes
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bertrand Cariou, MD, PhD
Phone
02 40 08 33 33
Ext
+33
Email
bertrand.cariou@univ-nantes.fr
First Name & Middle Initial & Last Name & Degree
Bertrand Cariou, MD, PhD
Facility Name
Hôpital Lyon Sud
City
Pierre-Bénite
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cyrielle CAUSSY, MD, PhD
Phone
04 78 86 44 48
Ext
+33
Email
cyrielle.caussy@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Dominique DELAUNAY
Phone
04.72.11.00.64
Ext
+33
Email
Dominique.delaunay@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Cyrielle CAUSSY, MD, PhD
12. IPD Sharing Statement
Learn more about this trial
Screening for NAFLD-related Advanced Fibrosis in High Risk Population in Diabetology.
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