Screening of Liver Fibrosis Using Blood Tests in Patients With Type 2 Diabetes Mellitus (L-FibroT2DM)

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 Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; NAFLD; NASH
• Intervention / Treatment: Diagnostic test: Blood tests

• Study Type: Interventional
• Enrollment (Actual): 722
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Angers, France, 49100
    • CHU d'Angers
  • Nantes, France, 44093
    • Chu de Nantes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Blood tests; Two diagnostic tests (eLift and FibroMeter) will be performed to evaluate liver fibrosis	Diagnostic test: Blood tests; eLift and FibroMeter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Investigators: Principal Investigator: Bertrand CARIOU, Pr, Nantes Hospital University

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2021
• Primary Completion (Actual): June 27, 2025
• Study Completion (Actual): June 27, 2025

Study Registration Dates

• First Submitted: January 6, 2020
• First Submitted That Met QC Criteria: January 14, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Estimated): November 18, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Fibrosis; NAFLD; NASH; Cirrhosis; Type 2 Diabetes Mellitus
• Additional Relevant MeSH Terms: Endocrine System Diseases; Pathologic Processes; Metabolic Diseases; Digestive System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Liver Diseases; Fatty Liver; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Fibrosis; Non-alcoholic Fatty Liver Disease; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests
• Other Study ID Numbers: RC19_0425

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No