Clinical trial NCT04232293: Screening of Liver Fibrosis Using Blood Tests in Patients With Type 2 Diabetes Mellitus
Official title: Screening of Liver Fibrosis Using Blood Tests in Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
NAFLD
NASH
Keywords: NASH
NAFLD
Fibrosis
Cirrhosis
Type 2 Diabetes Mellitus
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 806
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: eLift and FibroMeter sensitivity for the diagnosis of advanced hepatic fibrosis
timeFrame: Day 0
Secondary outcomes:
measure: number of advanced hepatic fibrosis diagnosed according to the FibroScan composite criterion and then liver biopsy
timeFrame: 3 months
measure: Controlled Attenuation Parameter (CAP) measurement by FibroScan
timeFrame: 3 months
measure: Patient rate with eLIFT ≥8 versus FibroMeter ≥0.22.
timeFrame: Day 0
measure: Liver hardness (kPa) measured by FibroScan
timeFrame: 3 months
measure: Complication of diabetes
timeFrame: Day 0
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU d'Angers
city: Nantes
country: France
facility: CHU de Nantes
Study officials:
affiliation: Nantes Hospital University
name: Bertrand CARIOU, Pr
role: PRINCIPAL_INVESTIGATOR
References: