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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
722
eLift and FibroMeter
CHU d'Angers
Angers, France
CHU de Nantes
Nantes, France
eLift and FibroMeter sensitivity for the diagnosis of advanced hepatic fibrosis
sensitivity calculated as follows: (number of patients with advanced hepatic fibrosis and a positive test) / (number of patients with advanced hepatic fibrosis)
Time frame: Day 0
number of advanced hepatic fibrosis diagnosed according to the FibroScan composite criterion and then liver biopsy
Time frame: 3 months
Controlled Attenuation Parameter (CAP) measurement by FibroScan
Time frame: 3 months
Patient rate with eLIFT ≥8 versus FibroMeter ≥0.22.
Time frame: Day 0
Liver hardness (kPa) measured by FibroScan
Time frame: 3 months
Complication of diabetes
Time frame: Day 0
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