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

NCT04232293 | Completed

• 1 other identifier: RC19_0425
• Study Type: interventional
• Target: 722
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetes Mellitus, Type 2; NAFLD; NASH

Keywords

NASH; NAFLD; Fibrosis; Cirrhosis; Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (1)

Blood tests

EXPERIMENTAL

Two diagnostic tests (eLift and FibroMeter) will be performed to evaluate liver fibrosis

Diagnostic Test: Blood tests

Interventions

Blood tests DIAGNOSTIC_TEST

eLift and FibroMeter

Blood tests

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (2)

CHU d'Angers

Angers, 49100, France

Location

CHU de Nantes

Nantes, 44093, France

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Non-alcoholic Fatty Liver Disease; Fibrosis

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Fatty Liver; Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Bertrand CARIOU, Pr

  Nantes Hospital University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2020
• First Posted: January 18, 2020
• Study Start: June 25, 2021
• Primary Completion: June 27, 2025
• Study Completion: June 27, 2025
• Last Updated: November 18, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)