Benefit of a Hospital Intervention in Patients With Hepatic Steatosis
NCT ID: NCT06394206
Last Updated: 2025-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
86 participants
INTERVENTIONAL
2025-12-31
2027-12-31
Brief Summary
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• 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Specialized Unit
This group of participants will be visited in the specialized consultation and will continue to receive the rest of their follow-up visits.
Specialized Unit
The participant will be visited every three months for one year
Usual Follow-Up
The participant will be visited as usual, it means they will be visited at Digestive Consultation
Usual Follow-Up
This group of participants will undergo their usual follow-up visits but will not be visited in the specialized consultation.
Usual Follow-Up
The participant will be visited as usual, it means they will be visited at Digestive Consultation
Interventions
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Specialized Unit
The participant will be visited every three months for one year
Usual Follow-Up
The participant will be visited as usual, it means they will be visited at Digestive Consultation
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Consorci Sanitari de l'Alt Penedès i Garraf
OTHER
Responsible Party
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Principal Investigators
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Lidia Tikhomirova, MD
Role: PRINCIPAL_INVESTIGATOR
CSAPG
Locations
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Consorci Sanitari Alt Penedes i Garraf
Sant Pere de Ribes, Barcelona, Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CSAPG-46
Identifier Type: -
Identifier Source: org_study_id
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