Screening of Liver Fibrosis Using Blood Tests in Patients With Type 2 Diabetes Mellitus (L-FibroT2DM)

Nantes University Hospital (NUH)

Status: Completed

Conditions: NASH; NAFLD; Diabetes Mellitus, Type 2

Treatments: Diagnostic Test: Blood tests

Study type: Interventional

Funder types: Other

Identifiers

NCT04232293

RC19_0425

Details and patient eligibility

About

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.

Enrollment: 722 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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722 participants in 1 patient group

Blood tests

Experimental group

Description:

Two diagnostic tests (eLift and FibroMeter) will be performed to evaluate liver fibrosis

Treatment:

Diagnostic Test: Blood tests