NCT04232293Completed
Screening of Liver Fibrosis Using Blood Tests in Patients With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov · Last updated 18 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 722 (actual)
- First submitted
- 6 Jan 2020
- Start date
- 25 Jun 2021
- Primary completion date
- 27 Jun 2025
- Lead sponsor
- Nantes University Hospital
- NCT number
- NCT04232293
What you commit to
- Study type: Interventional
- Participants enrolled: 722
- From 25 Jun 2021 to the primary completion date, 27 Jun 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Medical follow up for liver disease,
- Hospitalisation for acute complication: sepsis, infection, foot's ulcer, acute coronary syndrome,…
Lab values
- HbA1c \> 11,0 %,
Other
- Decompensated cirrhosis,
- Health status that does not allow the participation of the patient,
- Pregnancy.
- Patient under guardianship or curatorship or protection of justice
- Involvement refusal.
Who the study is looking for
- 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.
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU d Angers Coordinator of this site? Confirm its status | Angers | France | Unknown status |
| CHU de Nantes Coordinator of this site? Confirm its status | Nantes | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.