Using the Fatty Liver Index to improve cardiovascular risk management in primary care
Implementation of the Fatty Liver Index in Primary Care for Patients at Risk of Hepatic Steatosis to Optimize Clinical Control: Randomized Clinical Trial
This study tests if using the Fatty Liver Index screening in primary care can help doctors better manage heart health for patients at risk of liver fat buildup.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 434 (estimated) |
| Ages | 14 Years and up |
| Sex | All |
| Sponsor | Consorci Sanitari de l'Alt Penedès i Garraf Academic / other |
| Locations | 1 site (Vilanova I La Geltrú, Barcelona) |
| Trial ID | NCT06363617 on ClinicalTrials.gov |
What this trial studies
This trial evaluates how implementing the Fatty Liver Index (FLI) screening test in primary care affects cardiovascular risk management in patients at risk for hepatic steatosis. Medical teams at a primary care center will be divided into two groups: one will use the FLI in their clinical practice while the other will not. The study will compare the number of cardiovascular risk interventions made for patients in both groups to assess the effectiveness of the screening tool.
Who should consider this trial
Good fit: Ideal candidates include men and women aged 14 years and older with a body mass index of 25 or higher who are attending the participating primary care center.
Not a fit: Patients with chronic liver diseases, advanced chronic care needs, or those currently participating in other clinical trials may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance cardiovascular risk management for patients with overweight and obesity, potentially reducing the incidence of related health complications.
How similar studies have performed: While the specific implementation of the Fatty Liver Index in primary care is novel, similar screening approaches have shown promise in improving patient outcomes in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Men and women aged 14 years and older. * Attended at the Basic Care Units (BCU) participating in the Primary Care Center Baix a Mar study. * Intention to undergo medical follow-up at the study center. * Body mass index ≥ 25. Exclusion Criteria: * Pregnant women * Alcohol consumption habit (Standard Drink Unit (SDU); one SDU equals 10 grams of alcohol. Risky consumption is considered from 4 SDUs in men and 2 SDUs in women). * Displaced patients not assigned to the study center. * Patients classified as Advanced Chronic Care Model or Complex Chronic Patient. * Participants diagnosed with any of the following pathologies: Chronic liver diseases, including hepatic steatosis; Dementia; Active oncological diseases * Cognitive or affective pathology that limits the ability to collaborate with lifestyle interventions carried out at the center. * Patients under the care of endocrinology specialists. * Participation in another clinical trial involving an experimental intervention during the period of this trial.
Where this trial is running
Vilanova I La Geltrú, Barcelona
- Centro de Salud Vilanova i la Geltrú 3 Baix A Mar — Vilanova I La Geltrú, Barcelona, Spain (Recruiting)
Study contacts
- Principal investigator: M Carmen Rosas, MD — Csapg
- Study coordinator: M Carmen Rosas, MD
- Email: mrosas@csapg.cat
- Phone: +34 938 10 30 03
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.