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

Sponsor
Nantes University Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04232293
Collaborator
(none)
806
2
1
9
403
44.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Blood tests
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
806 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Screening of Liver Fibrosis Using Blood Tests in Patients With Type 2 Diabetes Mellitus
Anticipated Study Start Date :
Apr 1, 2021
Anticipated Primary Completion Date :
Jan 1, 2022
Anticipated Study Completion Date :
Jan 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. number of advanced hepatic fibrosis diagnosed according to the FibroScan composite criterion and then liver biopsy [3 months]

  2. Controlled Attenuation Parameter (CAP) measurement by FibroScan [3 months]

  3. Patient rate with eLIFT ≥8 versus FibroMeter ≥0.22. [Day 0]

  4. Liver hardness (kPa) measured by FibroScan [3 months]

  5. Complication of diabetes [Day 0]

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU d'Angers Angers France 49100
2 CHU de Nantes Nantes France 44093

Sponsors and Collaborators

  • Nantes University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT04232293
Other Study ID Numbers:
  • RC19_0425
First Posted:
Jan 18, 2020
Last Update Posted:
Mar 12, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Nantes University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 12, 2021