Hepatic SteatosisFLI-APNCT06363617
Implementation of the Fatty Liver Index in Primary Care
A study testing FLI in people with Hepatic Steatosis and Overweight and Obesity, run by Consorci Sanitari de l'Alt Penedès i Garraf at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Hepatic Steatosis, Overweight and Obesity
- What is being tested?
- FLI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 434 participants
- Where
- 1 siteSpain
- Study dates
- 2 May 2024to 1 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Centro de Salud Vilanova i la Geltrú 3 Baix A Mar
Vilanova i la Geltrú, Barcelona
About this study
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
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.
- Conditions
- Hepatic Steatosis, Overweight and Obesity
- Being tested
- FLI
- Medical subject headings
- Fatty Liver, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLIOther
Health professionals will use the FLI test in their clinical practice
| Study group | Role | What they receive |
|---|---|---|
| FLI test implementation | Experimental | A training session will be conducted for healthcare professionals on the risks of hepatic steatosis in patients with a body mass index (BMI) equal to or greater than 25. Additionally, professionals will be instructed in the use of the Fatty Liver Index (FLI) tool, validated for assessing the risk of steatosis. This tool will be implemented in the center's computer system, making it accessible via a link for the professionals receiving the intervention. Receives: Other: FLI |
| control | No intervention | This group of healthcare professionals will continue with their usual clinical practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lifestyle Intervention
Percentage of participants receiving a lifestyle intervention from the start of the study to month 6
Measured: Month 6
Secondary outcomes (8)
Low-density lipoprotein cholesterol
Value of low-density lipoprotein cholesterol (LDL cholesterol) in analyses performed between 6 months and one year post-intervention
Measured: Month 12
Triglycerides
Value of triglycerides in analyses performed between 6 months and one year post-intervention
Measured: Month 12
Gamma-glutamyl transpeptidase
Value of gamma-glutamyl transpeptidase in analyses performed between 6 months and one year post-intervention
Measured: Month 12
Medical and nursing visits
Number of medical and nursing visits in the year following the intervention.
Measured: Month 12
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.
Measured: Month 12
Lipid-lowering drugs
Number of prescriptions for lipid-lowering drugs.
Measured: Month 12
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.
Measured: Month 12
FLI administration
Percentage of patients with body mass index equal or more than 25 who have been administered the FLI
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start2 May 2024
- Primary completion1 Feb 2025
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic SteatosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 434 participants (actual)
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari de l'Alt Penedès i Garraf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- M Carmen Rosas, MD, Principal investigator, CSAPG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06363617
- Sponsor's protocol ID
- CSAPG-58
- Acronym
- FLI-AP
- Status last verified
- Jun 2025
- First submitted
- 9 Apr 2024
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD (without personal identification data) could be shared by requirement from other researchers after the end of the study, and only for research purposes and previous approval of promotor center of the study (CSAPG). Anyway, Spanish and European Union legal policy about data protection will strictly be followed (IPD will not be transferred outside European Union).
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06363617
- Acronym / sponsor ID
- FLI-AP / CSAPG-58
- Conditions
- Hepatic Steatosis, Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 434 participants (actual)
- Lead sponsor
- Consorci Sanitari de l'Alt Penedès i GarrafUniversity, hospital or other
- Study start
- 2 May 2024 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 12 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FLI test implementation | Experimental | Other: FLIA training session will be conducted for healthcare professionals on the risks of hepatic steatosis in patients with a body mass index (BMI) equal to or greater than 25. Additionally, professionals will be instructed in the use of the Fatty Liver Index (FLI) tool, validated for assessing the risk of steatosis. This tool will be implemented in the center's computer system, making it accessible via a link for the professionals receiving the intervention. |
| control | No intervention | –This group of healthcare professionals will continue with their usual clinical practice. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FLIHealth professionals will use the FLI test in their clinical practice | Other | FLI test implementation |
Primary outcome
Lifestyle Intervention
Time frame: Month 6
Percentage of participants receiving a lifestyle intervention from the start of the study to month 6
8 secondary outcomes
Low-density lipoprotein cholesterol
Time frame: Month 12
Triglycerides
Time frame: Month 12
Gamma-glutamyl transpeptidase
Time frame: Month 12
Medical and nursing visits
Time frame: Month 12
Analytical checks in the first year
Time frame: Month 12
Lipid-lowering drugs
Time frame: Month 12
Healthcare spending
Time frame: Month 12
FLI administration
Time frame: Month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
- Individual participant dataSharing planned: Yes. IPD (without personal identification data) could be shared by requirement from other researchers after the end of the study, and only for research purposes and previous approval of promotor center of the study (CSAPG). Anyway, Spanish and European Union legal policy about data protection will strictly be followed (IPD will not be transferred outside European Union).
Related trials for Hepatic Steatosis
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
Recruiting
Dietary Intervention Study on Liver Health in Young Adults
Liver Health
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
Non-alcoholic Fatty Liver Disease
Not yet recruiting
Personalized Dietary Feedback to Reduce Hepatic Steatosis in Patients With MASLD
MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease), MetALD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
M Carmen Rosas, MD principal investigator
CSAPG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FLI in people with Hepatic Steatosis and Overweight and Obesity, run by Consorci Sanitari de l'Alt Penedès i Garraf at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lifestyle Intervention (time frame: Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2025.