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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
CHU d'Angers
RECRUITING
Angers
CHU de Nantes
RECRUITING
Nantes
Contact Information
Primary
Bertrand CARIOU, Pr
bertrand.cariou@univ-nantes.fr
2.53.48.27.07
Backup
Jérôme BOUSIER, Pr
Jeboursier@chu-angers.fr
Time Frame
Start Date: 2021-06-25
Estimated Completion Date: 2025-03
Participants
Target number of participants: 806
Treatments
Experimental: Blood tests
Two diagnostic tests (eLift and FibroMeter) will be performed to evaluate liver fibrosis
Sponsors
Leads: Nantes University Hospital

This content was sourced from clinicaltrials.gov