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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06363617
Other study ID # CSAPG-58
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 2024
Est. completion date May 2025

Study information

Verified date April 2024
Source Consorci Sanitari de l'Alt Penedès i Garraf
Contact M Carmen Rosas, MD
Phone +34 938 10 30 03
Email mrosas@csapg.cat
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This trial aims to evaluate the impact on cardiovascular risk control in individuals in risk of being affected by hepatic steatosis through the implementation of a screening test (Fatty Liver Index) in Primary Care. Medical teams in a primary care center will be divided into 2 groups, with one group using the screening test in their clinical practice. The number of interventions on cardiovascular risk occurring in patients attended by each group of medical teams will be evaluated and compared.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 434
Est. completion date May 2025
Est. primary completion date May 2025
Accepts healthy volunteers No
Gender All
Age group 14 Years and older
Eligibility 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.

Study Design


Intervention

Other:
FLI
Health professionals will use the FLI test in their clinical practice

Locations

Country Name City State
Spain Centro de Salud Vilanova i la Geltrú 3 Baix A Mar Vilanova I La Geltrú Barcelona

Sponsors (1)

Lead Sponsor Collaborator
Consorci Sanitari de l'Alt Penedès i Garraf

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Lifestyle Intervention Percentage of participants receiving a lifestyle intervention from the start of the study to month 6 Month 6
Secondary Low-density lipoprotein cholesterol Value of low-density lipoprotein cholesterol (LDL cholesterol) in analyses performed between 6 months and one year post-intervention Month 12
Secondary Triglycerides Value of triglycerides in analyses performed between 6 months and one year post-intervention Month 12
Secondary Gamma-glutamyl transpeptidase Value of gamma-glutamyl transpeptidase in analyses performed between 6 months and one year post-intervention Month 12
Secondary Medical and nursing visits Number of medical and nursing visits in the year following the intervention. Month 12
Secondary Analytical checks in the first year Percentage of patients who had not undergone previous analytical checks according to protocol and who undergo analysis in the first year after the start of the study. Month 12
Secondary Lipid-lowering drugs Number of prescriptions for lipid-lowering drugs. Month 12
Secondary Healthcare spending Analysis of healthcare spending associated with each intervention, using billing data from the center associated with the use of resources by the insured party. Month 12
Secondary FLI administration Percentage of patients with body mass index equal or more than 25 who have been administered the FLI Month 12
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