Diabetes Mellitus, Type 2L-FibroT2DMNCT04232293
Screening of Liver Fibrosis Using Blood Tests in Patients With Type 2 Diabetes Mellitus
A study testing Blood tests in people with Diabetes Mellitus, Type 2 and NAFLD, run by Nantes University Hospital at 2 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, NAFLD, NASH
- What is being tested?
- Blood tests
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 722 participants
- Where
- 2 sitesFrance
- Study dates
- 25 Jun 2021to 27 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
About this study
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
- Being tested
- Blood tests
- Keywords
- NASH, NAFLD, Fibrosis, Cirrhosis, Type 2 Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus, Type 2, Non-alcoholic Fatty Liver Disease, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood testsDiagnostic test
eLift and FibroMeter
| Study group | Role | What they receive |
|---|---|---|
| Blood tests | Experimental | Two diagnostic tests (eLift and FibroMeter) will be performed to evaluate liver fibrosis Receives: Diagnostic Test: Blood tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Day 0
Secondary outcomes (5)
number of advanced hepatic fibrosis diagnosed according to the FibroScan composite criterion and then liver biopsy
Measured: 3 months
Controlled Attenuation Parameter (CAP) measurement by FibroScan
Measured: 3 months
Patient rate with eLIFT ≥8 versus FibroMeter ≥0.22.
Measured: Day 0
Liver hardness (kPa) measured by FibroScan
Measured: 3 months
Complication of diabetes
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start25 Jun 2021
- Primary completion27 Jun 2025
- Study completion27 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 722 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bertrand CARIOU, Pr, Principal investigator, Nantes Hospital University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04232293
- Sponsor's protocol ID
- RC19_0425
- Acronym
- L-FibroT2DM
- Status last verified
- Oct 2025
- First submitted
- 6 Jan 2020
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening of Liver Fibrosis Using Blood Tests in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04232293
- Acronym / sponsor ID
- L-FibroT2DM / RC19_0425
- Conditions
- Diabetes Mellitus, Type 2, NAFLD, NASH
- Keywords
- NASH, NAFLD, Fibrosis, Cirrhosis, Type 2 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 722 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 25 Jun 2021 (actual)
- Primary completion
- 27 Jun 2025 (actual)
- Study completion
- 27 Jun 2025 (actual)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood tests | Experimental | Diagnostic Test: Blood testsTwo diagnostic tests (eLift and FibroMeter) will be performed to evaluate liver fibrosis |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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 %,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood testseLift and FibroMeter | Diagnostic test | Blood tests |
Primary outcome
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)
5 secondary outcomes
number of advanced hepatic fibrosis diagnosed according to the FibroScan composite criterion and then liver biopsy
Time frame: 3 months
Controlled Attenuation Parameter (CAP) measurement by FibroScan
Time frame: 3 months
Patient rate with eLIFT ≥8 versus FibroMeter ≥0.22.
Time frame: Day 0
Liver hardness (kPa) measured by FibroScan
Time frame: 3 months
Complication of diabetes
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bertrand CARIOU, Pr principal investigator
Nantes Hospital University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood tests in people with Diabetes Mellitus, Type 2 and NAFLD, run by Nantes University Hospital at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
eLift and FibroMeter sensitivity for the diagnosis of advanced hepatic fibrosis (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.