Screening of Liver Fibrosis Using Blood Tests in Patients With Type 2 Diabetes Mellitus
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Nantes University Hospital
- Enrollment
- 722
- Locations
- 2
- Primary Endpoint
- eLift and FibroMeter sensitivity for the diagnosis of advanced hepatic fibrosis
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Blood tests
Two diagnostic tests (eLift and FibroMeter) will be performed to evaluate liver fibrosis
Intervention: Blood tests (Diagnostic Test)
Outcomes
Primary Outcomes
eLift and FibroMeter sensitivity for the diagnosis of advanced hepatic fibrosis
Time Frame: Day 0
sensitivity calculated as follows: (number of patients with advanced hepatic fibrosis and a positive test) / (number of patients with advanced hepatic fibrosis)
Secondary Outcomes
- Controlled Attenuation Parameter (CAP) measurement by FibroScan(3 months)
- Patient rate with eLIFT ≥8 versus FibroMeter ≥0.22.(Day 0)
- Complication of diabetes(Day 0)
- number of advanced hepatic fibrosis diagnosed according to the FibroScan composite criterion and then liver biopsy(3 months)
- Liver hardness (kPa) measured by FibroScan(3 months)