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

January 9, 2023 updated by: Nantes University Hospital

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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

806

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Angers, France, 49100
        • Recruiting
        • CHU d'Angers
        • Contact:
          • Jérôme BOURSIER, Pr
        • Principal Investigator:
          • Jérôme BOURSIER, Pr
      • Nantes, France, 44093
        • Recruiting
        • CHU de Nantes
        • Contact:
          • Bertrand CARIOU, Pr
        • Principal Investigator:
          • Bertrand CARIOU, Pr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: Day 0
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
Time Frame: 3 months
3 months
Controlled Attenuation Parameter (CAP) measurement by FibroScan
Time Frame: 3 months
3 months
Patient rate with eLIFT ≥8 versus FibroMeter ≥0.22.
Time Frame: Day 0
Day 0
Liver hardness (kPa) measured by FibroScan
Time Frame: 3 months
3 months
Complication of diabetes
Time Frame: Day 0
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 25, 2021

Primary Completion (Anticipated)

September 1, 2024

Study Completion (Anticipated)

September 1, 2024

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 (Estimate)

January 11, 2023

Last Update Submitted That Met QC Criteria

January 9, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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