Exploring the link between fatty liver disease and heart disease
EndoNAFLD: Evaluation of the Relationship Between Fatty Liver Disease and Endothelial Damage in Patients at High Risk of Cardiovascular Disease
This study is trying to see if having non-alcoholic fatty liver disease can increase the risk of heart problems in people.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 112 (estimated) |
| Ages | 50 Years to 69 Years |
| Sex | All |
| Sponsor | IMDEA Food Academic / other |
| Locations | 4 sites (Madrid and 3 other locations) |
| Trial ID | NCT06392828 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the relationship between non-alcoholic fatty liver disease (NAFLD) and cardiovascular diseases (CVD). It aims to determine if the prevalence and severity of NAFLD can serve as an independent risk factor for CVD, using non-invasive techniques and biomarkers to assess endothelial damage. The study will also explore the role of hepatic ketogenic metabolism in mediating endothelial damage and compare gene and microRNA expressions related to liver metabolism and inflammation. By understanding these connections, the study seeks to improve risk stratification for cardiovascular disease.
Who should consider this trial
Good fit: Ideal candidates for this study are men and women aged 50-69 with cardiovascular disease risk factors and available data to calculate NAFLD scores.
Not a fit: Patients with diabetes, chronic renal disease, or other specified conditions that affect liver metabolism or cardiovascular health may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the ability to predict cardiovascular risk in patients with fatty liver disease, leading to better prevention strategies.
How similar studies have performed: Preliminary studies have suggested a link between NAFLD and cardiovascular risk, but this specific approach is novel and aims to provide deeper insights into the mechanisms involved.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Men and women * 50-69 years old * With CVD stratification according to ESC 2011 guidelines. * With data to calculate NAFLD scores. Exclusion Criteria: Exclusion Criteria: * Type 1 or type 2 diabetes. * Taking hypoglycemic drugs. * Familiar hypercholesterolemia according to ESC criteria. * Congenital defects on lipid metabolism. * Taking hypolipidemic drugs targeting PCSK9. * Participating on other clinical trials. * Chronic renal disease with filtration rate \< 30 ml/min (RCD degree 4 KDIGO). * Active cancer * Liver disease no NAFLD. * Von Willebrand disease or any other genetic condition with an impact on the plasma concentration of this biomarker. * Systemic autoimmune disease. * Uncapable of giving informed consent. * Any other physical or cognitive condition that could affect the participation in the study.
Where this trial is running
Madrid and 3 other locations
- Clínica Universidad de Navarra — Madrid, Spain (Recruiting)
- Hospital 12 de Octubre — Madrid, Spain (Recruiting)
- Hospital Central de la Defensa Gomez Ulla — Madrid, Spain (Recruiting)
- Hospital HM Montepríncipe — Madrid, Spain (Recruiting)
Study contacts
- Principal investigator: Lidia Daimiel Ruiz, PhD — Fundación IMDEA Alimentación
- Study coordinator: Lidia Daimiel Ruiz, PhD
- Email: lidia.daimiel@alimentacion.imdea.org
- Phone: +34917278100
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.