Hepatic SteatosisBIPEHNCT06394206
Benefit of a Hospital Intervention in Patients With Hepatic Steatosis
A study testing Specialized Unit and Usual Follow-Up in people with Hepatic Steatosis, run by Consorci Sanitari de l'Alt Penedès i Garraf at 1 site in Spain.
Trial summary
The objective of this clinical trial is to determine whether a specialized consultation for controlling metabolic syndrome effectively treats hepatic steatosis in adults. The primary questions it aims to answer are: Does this specialized consultation increase the number of patients with hepatic steatosis who show… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatic Steatosis
- What is being tested?
- Specialized Unit and Usual Follow-Up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2025to Dec 2027
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients seen in outpatient gastroenterology clinics with hepatic steatosis.
- Diagnosed with hepatic steatosis through ultrasound or abdominal CT scan
- Mild to moderate fibrosis as assessed by elastography or FibroScan (F1-F3) or with a Fibrosis-4 (FIB-4) Index less than 3.5.
- Signature of informed consent for study inclusion, either by the participant themselves or by their legal representative.
Who cannot join
- Patients who do not have any hepatic imaging test conducted in the last 5 years.
- Conditions other than hepatic steatosis requiring gastroenterological follow-up.
- Abusive alcohol consumption, defined as weekly intake of > 50 g in women and more than 70 g in men.
- Cognitive or affective disorders limiting the ability to cooperate with study procedures.
- Participation in another clinical trial involving experimental intervention during the period of this trial and/or establishing visit schedules incompatible with this trial.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Consorci Sanitari Alt Penedes i Garraf
Sant Pere de Ribes, Barcelona, 08810
About this study
The objective of this clinical trial is to determine whether a specialized consultation for controlling metabolic syndrome effectively treats hepatic steatosis in adults. The primary questions it aims to answer are:
- Does this specialized consultation increase the number of patients with hepatic steatosis who show improvement after one year of clinical follow-up in said consultation?
Read more
The improvement of the disease will be assessed through the following parameters:
- liver laboratory tests
- weight loss
- improvement in cholesterol and triglyceride levels. Researchers will compare follow-up in the specialized consultation to standard follow-up to assess the effectiveness of the specialized consultation in treating hepatic steatosis.
Participants will be randomly assigned to two groups. The first group will be visited in the specialized consultation every three months for one year and will continue to receive the rest of their follow-up visits. The second group will undergo their usual follow-up visits but will not be visited in the specialized consultation.
- Conditions
- Hepatic Steatosis
- Being tested
- Specialized Unit, Usual Follow-Up
- Keywords
- Fatty Liver, Metabolic Syndrome
- Medical subject headings
- Fatty Liver, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specialized UnitOther
The participant will be visited every three months for one year
Usual Follow-UpOther
The participant will be visited as usual, it means they will be visited at Digestive Consultation
| Study group | Role | What they receive |
|---|---|---|
| Specialized Unit | Experimental | This group of participants will be visited in the specialized consultation and will continue to receive the rest of their follow-up visits. Receives: Other: Specialized Unit; Other: Usual Follow-Up |
| Usual Follow-Up | Active comparator | This group of participants will undergo their usual follow-up visits but will not be visited in the specialized consultation. Receives: Other: Usual Follow-Up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discharge criteria from the gastroenterology clinic
Percentage of patients meeting discharge criteria (defined by the trial) from the gastroenterology clinic at the end of the study
Measured: 1 year
Secondary outcomes (12)
Discharge from the gastroenterology clinic after achieving metabolic control goals
Difference in the percentage of patients discharged from the gastroenterology clinic after achieving metabolic control goals
Measured: 1 year
Change on Test de Owliver
Change in the Owliver test compared to baseline
Measured: 1 year
Change on liver enzymes
Change compared to baseline in the liver enzymes (UI/mL)
Measured: 1 year
Change on total cholesterol
Change compared to baseline in the total cholesterol (mg/dL)
Measured: 1 year
Change on LDL- cholesterol
Change compared to baseline in the LDL- cholesterol (mg/dL)
Measured: 1 year
Change on HDL- cholesterol
Change compared to baseline in the HDL- cholesterol (mg/dL)
Measured: 1 year
Change on triglycerides
Change compared to baseline in the triglycerides (mg/dL)
Measured: 1 year
Change on Fibrosis-4 Index
Change compared to baseline on Fibrosis-4 Index
Measured: 1 year
Change on Hepatic Fibrosis
Change compared to baseline on Fibroscan score
Measured: 1 year
Glycated hemoglobin
In diabetic patients, change compared to baseline on glycated hemoglobin
Measured: 1 yera
Insulin resistance
In patients with insulin resistance, change compared to baseline on Insulin Resistance Index
Measured: 1 year
Body Mass Index
Change compared to baseline on body mass index
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study startDec 2025 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Why it stopped: Funding issues
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
- 0 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
- Lidia Tikhomirova, MD, Principal investigator, CSAPG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06394206
- Sponsor's protocol ID
- CSAPG-46
- Acronym
- BIPEH
- Status last verified
- Oct 2026
- First submitted
- 25 Apr 2024
- Last updated
- 28 Oct 2026
- 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 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefit of a Hospital Intervention in Patients With Hepatic Steatosis
- ClinicalTrials.gov ID
- NCT06394206
- Acronym / sponsor ID
- BIPEH / CSAPG-46
- Conditions
- Hepatic Steatosis
- Keywords
- Fatty Liver, Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Consorci Sanitari de l'Alt Penedès i GarrafUniversity, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 1 May 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.
The objective of this clinical trial is to determine whether a specialized consultation for controlling metabolic syndrome effectively treats hepatic steatosis in adults. The primary questions it aims to answer are:
- Does this specialized consultation increase the number of patients with hepatic steatosis who show improvement after one year of clinical follow-up in said consultation?
The improvement of the disease will be assessed through the following parameters:
- liver laboratory tests
- weight loss
- improvement in cholesterol and triglyceride levels. Researchers will compare follow-up in the specialized consultation to standard follow-up to assess the effectiveness of the specialized consultation in treating hepatic steatosis.
Participants will be randomly assigned to two groups. The first group will be visited in the specialized consultation every three months for one year and will continue to receive the rest of their follow-up visits. The second group will undergo their usual follow-up visits but will not be visited in the specialized consultation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Specialized Unit | Experimental | Other: Specialized Unit, Other: Usual Follow-UpThis group of participants will be visited in the specialized consultation and will continue to receive the rest of their follow-up visits. |
| Usual Follow-Up | Active comparator | Other: Usual Follow-UpThis group of participants will undergo their usual follow-up visits but will not be visited in the specialized consultation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients seen in outpatient gastroenterology clinics with hepatic steatosis.
- Diagnosed with hepatic steatosis through ultrasound or abdominal CT scan
- Mild to moderate fibrosis as assessed by elastography or FibroScan (F1-F3) or with a Fibrosis-4 (FIB-4) Index less than 3.5.
- Signature of informed consent for study inclusion, either by the participant themselves or by their legal representative.
Key exclusion criteria (5 listed)
- Patients who do not have any hepatic imaging test conducted in the last 5 years.
- Conditions other than hepatic steatosis requiring gastroenterological follow-up.
- Abusive alcohol consumption, defined as weekly intake of > 50 g in women and more than 70 g in men.
- Cognitive or affective disorders limiting the ability to cooperate with study procedures.
- Participation in another clinical trial involving experimental intervention during the period of this trial and/or establishing visit schedules incompatible with this trial.
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 |
|---|---|---|
| Specialized UnitThe participant will be visited every three months for one year | Other | Specialized Unit |
| Usual Follow-UpThe participant will be visited as usual, it means they will be visited at Digestive Consultation | Other | Specialized Unit, Usual Follow-Up |
Primary outcome
Discharge criteria from the gastroenterology clinic
Time frame: 1 year
Percentage of patients meeting discharge criteria (defined by the trial) from the gastroenterology clinic at the end of the study
12 secondary outcomes
Discharge from the gastroenterology clinic after achieving metabolic control goals
Time frame: 1 year
Change on Test de Owliver
Time frame: 1 year
Change on liver enzymes
Time frame: 1 year
Change on total cholesterol
Time frame: 1 year
Change on LDL- cholesterol
Time frame: 1 year
Change on HDL- cholesterol
Time frame: 1 year
Change on triglycerides
Time frame: 1 year
Change on Fibrosis-4 Index
Time frame: 1 year
Change on Hepatic Fibrosis
Time frame: 1 year
Glycated hemoglobin
Time frame: 1 yera
Insulin resistance
Time frame: 1 year
Body Mass Index
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- 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
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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.
Lidia Tikhomirova, 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 Specialized Unit and Usual Follow-Up in people with Hepatic Steatosis, 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 5 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: withdrawn, as of the sponsor's last update on 28 Oct 2026. 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 was withdrawn before enrolling participants, so there are no results.
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?
Discharge criteria from the gastroenterology clinic (time frame: 1 year). 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 28 Oct 2026.