Benefit of a Hospital Intervention in Patients With Hepatic Steatosis
BIPEH
1 other identifier
interventional
86
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 25, 2024
CompletedFirst Posted
Study publicly available on registry
May 1, 2024
CompletedStudy Start
First participant enrolled
December 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
February 12, 2025
February 1, 2025
2 years
April 25, 2024
February 10, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
1 year
Secondary Outcomes (12)
Discharge from the gastroenterology clinic after achieving metabolic control goals
1 year
Change on Test de Owliver
1 year
Change on liver enzymes
1 year
Change on total cholesterol
1 year
Change on LDL- cholesterol
1 year
- +7 more secondary outcomes
Study Arms (2)
Specialized Unit
EXPERIMENTALThis 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 COMPARATORThis group of participants will undergo their usual follow-up visits but will not be visited in the specialized consultation.
Interventions
The participant will be visited every three months for one year
The participant will be visited as usual, it means they will be visited at Digestive Consultation
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Consorci Sanitari Alt Penedes i Garraf
Sant Pere de Ribes, Barcelona, 08810, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lidia Tikhomirova, MD
CSAPG
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 25, 2024
First Posted
May 1, 2024
Study Start
December 1, 2025
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
February 12, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- After publication of main results of the study.
- Access Criteria
- IPD will be shared only for scientific research purposes and following the Spanish and European Union normative law about data protection. The requirements will be directed to the IP of the study. The IP will evaluate the request to verify and evaluate the data that is requested and the purposes for which it is requested. Next, the IP will transfer the request to the promotor center the study for the final decision.
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).