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NCT Number: NCT04232293

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

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU d'Angers, Angers, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood tests

Diagnostic Test

eLift and FibroMeter

Primary outcomes

  1. 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)

Secondary outcomes

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

    Time frame: 3 months

  2. Controlled Attenuation Parameter (CAP) measurement by FibroScan

    Time frame: 3 months

  3. Patient rate with eLIFT ≥8 versus FibroMeter ≥0.22.

    Time frame: Day 0

  4. Liver hardness (kPa) measured by FibroScan

    Time frame: 3 months

  5. Complication of diabetes

    Time frame: Day 0

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Acronym: L-FibroT2DM

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jan 18, 2020
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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