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

Primary Purpose

Diabetes Mellitus, Type 2, NAFLD, NASH

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood tests
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Diabetes Mellitus, Type 2 focused on measuring NASH, NAFLD, Fibrosis, Cirrhosis, Type 2 Diabetes Mellitus

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHU d'AngersRecruiting
  • CHU de NantesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Blood tests

Arm Description

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

First Posted
January 6, 2020
Last Updated
January 9, 2023
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04232293
Brief Title
Screening of Liver Fibrosis Using Blood Tests in Patients With Type 2 Diabetes Mellitus
Acronym
L-FibroT2DM
Official Title
Screening of Liver Fibrosis Using Blood Tests in Patients With Type 2 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 25, 2021 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, NAFLD, NASH
Keywords
NASH, NAFLD, Fibrosis, Cirrhosis, Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
806 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Blood tests
Arm Type
Experimental
Arm Description
Two diagnostic tests (eLift and FibroMeter) will be performed to evaluate liver fibrosis
Intervention Type
Diagnostic Test
Intervention Name(s)
Blood tests
Intervention Description
eLift and FibroMeter
Primary Outcome Measure Information:
Title
eLift and FibroMeter sensitivity for the diagnosis of advanced hepatic fibrosis
Description
sensitivity calculated as follows: (number of patients with advanced hepatic fibrosis and a positive test) / (number of patients with advanced hepatic fibrosis)
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
number of advanced hepatic fibrosis diagnosed according to the FibroScan composite criterion and then liver biopsy
Time Frame
3 months
Title
Controlled Attenuation Parameter (CAP) measurement by FibroScan
Time Frame
3 months
Title
Patient rate with eLIFT ≥8 versus FibroMeter ≥0.22.
Time Frame
Day 0
Title
Liver hardness (kPa) measured by FibroScan
Time Frame
3 months
Title
Complication of diabetes
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bertrand CARIOU, Pr
Phone
2.53.48.27.07
Ext
+33
Email
bertrand.cariou@univ-nantes.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Jérôme BOUSIER, Pr
Email
Jeboursier@chu-angers.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bertrand CARIOU, Pr
Organizational Affiliation
Nantes Hospital University
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU d'Angers
City
Angers
ZIP/Postal Code
49100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jérôme BOURSIER, Pr
First Name & Middle Initial & Last Name & Degree
Jérôme BOURSIER, Pr
Facility Name
CHU de Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bertrand CARIOU, Pr
First Name & Middle Initial & Last Name & Degree
Bertrand CARIOU, Pr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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