Screening liver fibrosis in patients with type 2 diabetes using blood tests
Screening of Liver Fibrosis Using Blood Tests in Patients With Type 2 Diabetes Mellitus
NA · Nantes University Hospital · NCT04232293
This study is testing whether blood tests can help find liver fibrosis in people over 40 with type 2 diabetes, instead of using more invasive liver biopsies.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 806 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Nantes University Hospital (other) |
| Locations | 2 sites (Angers and 1 other locations) |
| Trial ID | NCT04232293 on ClinicalTrials.gov |
What this trial studies
This study aims to screen for liver fibrosis in patients with type 2 diabetes mellitus, a condition often associated with Non-Alcoholic Fatty Liver Disease (NAFLD) and Non-Alcoholic SteatoHepatitis (NASH). Given the invasive nature of liver biopsies, the study will utilize blood tests as a non-invasive alternative to assess liver health. The research focuses on patients aged 40 and older who have been diagnosed with type 2 diabetes for at least six months and meet specific health criteria. By identifying liver fibrosis early, the study hopes to improve patient management and outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 40 and older with type 2 diabetes for more than six months and specific body measurements indicating obesity.
Not a fit: Patients with existing liver disease, decompensated cirrhosis, or acute health complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more accessible method for early detection of liver fibrosis in patients with type 2 diabetes.
How similar studies have performed: Other studies have shown promise in using non-invasive methods for assessing liver health in similar patient populations, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Angers and 1 other locations
- CHU d'Angers — Angers, France (RECRUITING)
- CHU de Nantes — Nantes, France (RECRUITING)
Study contacts
- Principal investigator: Bertrand CARIOU, Pr — Nantes Hospital University
- Study coordinator: Bertrand CARIOU, Pr
- Email: bertrand.cariou@univ-nantes.fr
- Phone: 2.53.48.27.07
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Diabetes Mellitus, Type 2, NAFLD, NASH, Fibrosis, Cirrhosis, Type 2 Diabetes Mellitus