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Screening of Liver Fibrosis Using Blood Tests in Patients With Type 2 Diabetes Mellitus

Recruiting
40 years of age
Both
Phase N/A

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Overview

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.

Eligibility

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.

Study details

Diabetes Mellitus, Type 2, NAFLD, NASH

NCT04232293

Nantes University Hospital

21 May 2024

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