Actively Recruiting
Type 2 DIAbeTes With NAFLD: innOvative Biomarkers of Disease progressioN and clInical outComes
Led by Hospices Civils de Lyon · Updated on 2026-01-28
500
Participants Needed
4
Research Sites
138 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Type 2 DIAbeTes With NAFLD: innOvative Biomarkers of Disease progressioN and clInical outComes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient aged between 40 and 80 years old
- Patient has type 2 diabetes
- Patient has hepatic steatosis confirmed by conventional abdominal ultrasound
- Patient agrees to participate and signs the informed consent form
- Patient is affiliated with a healthcare insurance plan
You will not qualify if you...
- Diagnosis of cirrhosis by liver biopsy or magnetic resonance imaging
- Evidence of other chronic liver diseases such as hepatitis B, hepatitis C, autoimmune hepatitis, autoimmune cholestatic liver disorders, Wilson disease, alpha-1-antitrypsin deficiency, hemochromatosis, drug-induced liver disease, or bile duct obstruction
- History of medications causing steatosis in the past 6 months
- Known cirrhosis or portal hypertension symptoms such as ascites, hepatic encephalopathy, or varices
- Regular or excessive alcohol use exceeding defined limits for males and females over more than 2 years in the past 10 years
- Pregnant or nursing women
- Life expectancy less than 5 years
- Known HIV infection
- History of type 1 diabetes
- Body mass index (BMI) of 45 kg/m2 or higher
- Mentally unbalanced or under guardianship
- Deprived of liberty
- Unable to understand French or unable to give consent
- Currently enrolled in interfering clinical trials or within exclusion period after previous trial participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
Service Endocrinologie, Diabétologie, Maladies Métaboliques et Nutrition
Dijon, France, BP 1542- 14
Actively Recruiting
2
Endocrinologie, Diabète et Nutrition in Louis PRADEL Hospital
Lyon, France, 69677
Actively Recruiting
3
Clinique d'Endocrinologie, Maladies Métaboliques et Nutrition CIC Endocrino-Nut
Nantes, France, 44093
Actively Recruiting
4
Service d'Endocrinologie, Diabète et nutrition
Pierre-Bénite, France, 69495
Actively Recruiting
Research Team
C
Cyrielle CAUSSY, Pr
CONTACT
D
Dominique DELAUNAY, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
SCREENING
Number of Arms
2
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