EndoNAFLD: Relationship Between Fatty Liver Disease and Cardiovascular Diseases

NCT06392828 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 63

Last updated 2026-03-25

No results posted yet for this study

Summary

Management of risk factors is the primary approach to prevent cardiovascular disease (CVD). In this regard the accurate scoring of disease risk is fundamental. Non-alcoholic fatty liver disease (NAFLD) has emerged recently as a potential mediator of CVD onset and progression. The hypothesis is that NAFLD can be a predictive CVD risk factor, independent of other classical and well-known risk factors.

Preliminary epidemiological studies suggested that the fat infiltration in the liver mirrored the cardiometabolic status of the patient. But recent studies postulate that NAFLD could be a potential independent predictor of vascular injury.

The mechanisms that link liver function and endothelial damage include modulation of adipose tissue function, lipid metabolism regulation or glycemic homeostasis, among others. But new mechanisms that could link NAFLD and ECV are emerging. The synthesis of ketone bodies in the liver is closely related to the cardiovascular system function. Ketone bodies can provide up to 50% of energy required by specific tissues. Plasma concentration of β-hydroxybutyrate is a biomarker of NAFLD. Plasma β-hydroxybutyrate and acetoacetate levels are also inversely associated with endothelial injury.

Other biomarkers on endothelial damage like von Willebrand factor, ICAM, VCAM or coagulation factors (Factor VIII) can be used to stratify patients according to the risk of CVD. The improvement in the sensitivity, specificity and accuracy of scores such as FLI, HIS and FIB-4 and non-invasive techniques such as elastography allow the study of the relationship between liver disease and other comorbidities.

The aim is to evaluate the potential of NAFLD to stratify patients according to the risk of CVD and to investigate the molecular mechanisms linking NAFLD and CVD.

Conditions

Sponsors & Collaborators

  • Sociedad Española de Arteriosclerosis

    collaborator OTHER
  • Clinica Universidad de Navarra, Universidad de Navarra

    collaborator OTHER
  • Hospital HM Montepríncipe

    collaborator UNKNOWN
  • Hospital Central de la Defensa Gómez Ulla

    collaborator OTHER
  • Hospital Universitario 12 de Octubre

    collaborator OTHER
  • IMDEA Food

    lead OTHER

Principal Investigators

  • Lidia Daimiel Ruiz, PhD · Fundación IMDEA Alimentación

  • Diego Martínez Urbistondo, PhD · Clínica Universidad de Navarra

Eligibility

Min Age
50 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-15
Primary Completion
2026-02-19
Completion
2026-02-19

Countries

  • Spain

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06392828 on ClinicalTrials.gov