NCT06392828Completed
EndoNAFLD: Relationship Between Fatty Liver Disease and Cardiovascular Diseases
EndoNAFLD: Evaluation of the Relationship Between Fatty Liver Disease and Endothelial Damage in Patients at High Risk of Cardiovascular Disease
Source: ClinicalTrials.gov · Last updated 25 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 63 (actual)
- First submitted
- 25 Apr 2024
- Start date
- 15 Apr 2024
- Primary completion date
- 19 Feb 2026
- Lead sponsor
- IMDEA Food
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT06392828
What you commit to
- Study type: Observational
- Participants enrolled: 63
- From 15 Apr 2024 to the primary completion date, 19 Feb 2026
- 4 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.
Prior treatment
- Taking hypoglycemic drugs.
- Taking hypolipidemic drugs targeting PCSK9.
Other illness
- Type 1 or type 2 diabetes.
- 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.
- Any other physical or cognitive condition that could affect the participation in the study.
Other
- Familiar hypercholesterolemia according to ESC criteria.
- Congenital defects on lipid metabolism.
- Participating on other clinical trials.
- Uncapable of giving informed consent.
Who the study is looking for
- Men and women
- 50-69 years old
- With CVD stratification according to ESC 2011 guidelines.
- With data to calculate NAFLD scores.
Age in the registry: 50 years to 69 years · Sex: All
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinica Universidad de Navarra Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital HM Montepríncipe Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Central de la Defensa Gómez Ulla Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.