Informations générales (source: ClinicalTrials.gov)
Screening of Liver Fibrosis Using Blood Tests in Patients With Type 2 Diabetes Mellitus (L-FibroT2DM)
Interventional
N/A
Nantes University Hospital (Voir sur ClinicalTrials)
juin 2021
mars 2025
29 juin 2024
Non-Alcoholic Fatty Liver Disease (NAFLD) and Non-Alcoholic SteatoHepatitis (NASH), are a
frequent complication of type 2 diabetes and obesity. This disease has been linked with
an increased morbidity and mortality, in particular cardiovascular disease and hepatic
complications (cirrhosis and hepatocellular carcinoma). NAFLD is covered different liver
damage in ascending order: steatosis, Non-Alcoholic SteatoHepatitis (NASH), fibrosis, and
finally cirrhosis. Mostly, fibrosis has a determining role in the patient's status
health. The fibrosis prevalence rate may reach up to 15 % of people with type 2 diabetes.
The purpose of the study is to screen hepatic fibrosis for patient with type 2 diabetes.
To be sure of the status of the disease, the gold standard procedure remains liver
biopsy. However, it's an invasive procedure and it's a challenge to perform this kind of
medical procedure to every patient with NAFLD. Some alternative procedure exists, called
FibroScan that gives some indication of liver fibrosis status. Unfortunately, every
diabetologist hasn't this equipment in his medical office. The investigators propose to
evaluate two non-invasive biological fibrosis tests, called eLIFT and FibroMeter. The
results of these two diagnostic tests will be compared to FibroScan and to liver biopsy
results.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHU d'Angers - 49100 - Angers - France | Jérôme BOURSIER, Pr | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU de Nantes - 44093 - Nantes - France | Bertrand CARIOU, Pr | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Age ≥ 40 years old,
- Type 2 diabetes mellitus for more than 6 months,
- BMI > 25 kg/m2,
- Waist circumference > 94 cm (male) or 80 cm (female).
- Patient benefiting from a social security system.
- Age ≥ 40 years old,
- Type 2 diabetes mellitus for more than 6 months,
- BMI > 25 kg/m2,
- Waist circumference > 94 cm (male) or 80 cm (female).
- Patient benefiting from a social security system.
- Medical follow up for liver disease,
- Decompensated cirrhosis,
- Health status that does not allow the participation of the patient,
- Hospitalisation for acute complication: sepsis, infection, foot's ulcer, acute
coronary syndrome,...
- HbA1c > 11,0 %,
- Pregnancy.
- Patient under guardianship or curatorship or protection of justice
- Involvement refusal.