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

Diabetes Mellitus, Type 2 Clinical Trial

— L-FibroT2DM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04232293
• Other study ID #: RC19_0425
• Status: Recruiting
• Phase: N/A
• Start date: June 25, 2021
• Est. completion date: March 2025

Study information

• Verified date: May 2024
• Source: Nantes University Hospital
• Contact: Bertrand CARIOU, Pr
• Phone: 2.53.48.27.07
• Email: bertrand.cariou[@]univ-nantes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 806
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Fibrosis
• Liver Cirrhosis
• NAFLD
• NASH

Intervention

Diagnostic Test:
• Blood tests
eLift and FibroMeter

Locations

Country	Name	City	State
France	CHU d'Angers	Angers
France	CHU de Nantes	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Day 0
Secondary	number of advanced hepatic fibrosis diagnosed according to the FibroScan composite criterion and then liver biopsy		3 months
Secondary	Controlled Attenuation Parameter (CAP) measurement by FibroScan		3 months
Secondary	Patient rate with eLIFT =8 versus FibroMeter =0.22.		Day 0
Secondary	Liver hardness (kPa) measured by FibroScan		3 months
Secondary	Complication of diabetes		Day 0