Type 2 DIAbeTes With NAFLD: innOvative Biomarkers of Disease progressioN and clInical outComes
DIATONIC
1 other identifier
interventional
500
1 country
4
Brief Summary
Type 2 diabetes (T2DM) patients are at high-risk for advanced fibrosis (AF) due to non-alcoholic fatty liver disease (NAFLD), recently renamed Metabolic dysfunction-Associated Liver Disease (MASLD). Thus, patients with T2DM are recognized as a priority target for the screening of MASLD-related advanced fibrosis and a systematic screening for AF is currently recommended in T2DM patients using FIB-4 and liver stiffness measurement (LSM).The main objective of the project is to investigate the ability of baseline non-invasive biomarkers to discriminate patients with a progression of MASLD from patients without progression of MASLD among patients with T2DM and to investigate the association between clinical outcomes related to the natural evolution of MASLD and T2DM and baseline biomarkers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2024
Typical duration for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 20, 2024
CompletedFirst Posted
Study publicly available on registry
August 23, 2024
CompletedStudy Start
First participant enrolled
September 25, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 25, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 25, 2027
January 28, 2026
January 1, 2026
2.7 years
August 20, 2024
January 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression of MASLD for T2D and MASLD patients without AF at baseline (cohort A) or progression to confirmed diagnosis of cirrhosis for T2D and MASLD patients with presence of AF at baseline and without cirrhosis (cohort B).
COHORT A = Composite outcome defined by either histological stage of fibrosis ≥ F3 if a liver biopsy is performed in clinical care or concordant patented Fibrotest≥ F3 and LSM≥ 8 kPa according to EASL guidelines or overt imaging evidence of cirrhosis via ultrasound, computed tomography (CT), or MRI COHORT B = Histological stage of fibrosis 4 or imaging evidence of cirrhosis via ultrasound, computed tomography (CT), or MRI
One time visit planned according to standard care at 4 years+/- 6 months after inclusion in the NAFLD-CARE study
Secondary Outcomes (1)
Assessment of clinical events associated with the natural history of MASLD and T2D for both cohorts
One time visit planned according to standard care at 4 years+/- 6 months after inclusion in the NAFLD-CARE study
Study Arms (2)
Patients with T2D and MASLD without advanced fibrosis (AF) (COHORT A)
OTHERPatients with T2D and MASLD without advanced fibrosis (AF) at baseline in the NAFLD-Care study.
Patients with T2D and MASLD, without diagnosis of cirrhosis (COHORT B)
OTHERPatients with T2D and MASLD with presence of advanced fibrosis (AF) and without cirrhosis at baseline in the NAFLD-Care study
Interventions
* Non-invasive blood biological tests = NAFLD Fibrosis Score, FIB-4 score, FNI score, Agile3+ score, FASTscore, ELF, Fibrotest, Fibrometer if performed in clinical care * Non-invasive imaging = Transient elastography (FibroScan), Questionnaire assessing alcohol consumption
Eligibility Criteria
You may qualify if:
- Patient aged between 40 and 80 years old,
- 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.
You may not qualify if:
- \- Participants with a diagnosis of cirrhosis defined by a liver biopsy with histological stage of fibrosis F4 or a proven diagnosis of cirrhosis by magnetic resonance imaging.
- Evidence of other causes of chronic liver disease :
- Hepatitis B as defined as presence of hepatitis B surface antigen (HBsAg).
- Previous or current infection with Hepatitis C as defined by presence of hepatitis C virus Ab in serum (anti-HCV Ab).
- Autoimmune hepatitis as defined by anti-nuclear antibody (ANA) of 1:160 or greater and liver histology consistent with autoimmune hepatitis or previous response to immunosuppressive therapy.
- Autoimmune cholestatic liver disorders as defined by elevation of alkaline phosphatase and anti-mitochondrial antibody of greater than 1:80 or liver histology consistent with primary biliary cirrhosis or elevation of alkaline phosphatase and liver histology consistent with sclerosing cholangitis.
- Wilson disease as defined by ceruloplasmin below the limits of normal and liver histology consistent with Wilson disease.
- Alpha-1-antitrypsin deficiency as defined by alpha-1-antitrypsin level less than normal and liver histology consistent with alpha-1-antitrypsin deficiency.
- Hemochromatosis as defined by presence of 3+ or 4+ stainable iron on liver biopsy and homozygosity for C282Y or compound heterozygosity for C282Y/H63D.
- Drug-induced liver disease as defined on the basis of typical exposure and history.
- Bile duct obstruction as shown by imaging studies.
- 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
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Service Endocrinologie, Diabétologie, Maladies Métaboliques et Nutrition
Dijon, BP 1542- 14, France
Endocrinologie, Diabète et Nutrition in Louis PRADEL Hospital
Lyon, 69677, France
Clinique d'Endocrinologie, Maladies Métaboliques et Nutrition CIC Endocrino-Nut
Nantes, 44093, France
Service d'Endocrinologie, Diabète et nutrition
Pierre-Bénite, 69495, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 20, 2024
First Posted
August 23, 2024
Study Start
September 25, 2024
Primary Completion (Estimated)
May 25, 2027
Study Completion (Estimated)
May 25, 2027
Last Updated
January 28, 2026
Record last verified: 2026-01