Implementation of the Fatty Liver Index in Primary Care

Overweight and Obesity Clinical Trial

— FLI-AP  

Official title:

Implementation of the Fatty Liver Index in Primary Care for Patients at Risk of Hepatic Steatosis to Optimize Clinical Control: Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06363617
• Other study ID #: CSAPG-58
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Fatty Liver
• Hepatic Steatosis
• Overweight
• Overweight and Obesity

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