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

Not Applicable

Recruiting

• Conditions: Diabetes Mellitus, Type 2; NASH; NAFLD
• Interventions: Diagnostic Test: Blood tests

• Registration Number: NCT04232293
• Lead Sponsor: Nantes University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-06
• Study First Submitted QC: 2020-01-14
• Study First Posted: 2020-01-18
• Study Start: 2021-06-25
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-10
• Last Update Posted: 2024-05-13
• Primary Completion: 2025-03
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 806

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Blood tests	Blood tests	Two diagnostic tests (eLift and FibroMeter) will be performed to evaluate liver fibrosis

Primary Outcome Measures

Name	Time	Method
eLift and FibroMeter sensitivity for the diagnosis of advanced hepatic fibrosis	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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

CHU d'Angers; 🇫🇷 Angers, France

CHU de Nantes; 🇫🇷 Nantes, France