Benefit of a Hospital Intervention in Patients with Hepatic Steatosis

Not Applicable

Not yet recruiting

• Conditions: Hepatic Steatosis
• Interventions: Other: Specialized Unit; Other: Usual Follow-Up

• Registration Number: NCT06394206
• Lead Sponsor: Consorci Sanitari de l'Alt Penedès i Garraf

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-25
• Study First Submitted QC: 2024-04-30
• Study First Posted: 2024-05-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-12
• Study Start: 2025-12
• Primary Completion: 2027-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Specialized Unit	Usual Follow-Up	This 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	Usual Follow-Up	This group of participants will undergo their usual follow-up visits but will not be visited in the specialized consultation.
Specialized Unit	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.

Primary Outcome Measures

Name	Time	Method
Discharge criteria from the gastroenterology clinic	1 year	Percentage of patients meeting discharge criteria (defined by the trial) from the gastroenterology clinic at the end of the study

Secondary Outcome Measures

Name	Time	Method
Change on total cholesterol	1 year	Change compared to baseline in the total cholesterol (mg/dL)
Change on triglycerides	1 year	Change compared to baseline in the triglycerides (mg/dL)
Change on liver enzymes	1 year	Change compared to baseline in the liver enzymes (UI/mL)
Change on LDL- cholesterol	1 year	Change compared to baseline in the LDL- cholesterol (mg/dL)
Change on Hepatic Fibrosis	1 year	Change compared to baseline on Fibroscan score
Change on Test de Owliver	1 year	Change in the Owliver test compared to baseline
Glycated hemoglobin	1 yera	In diabetic patients, change compared to baseline on glycated hemoglobin
Body Mass Index	1 year	Change compared to baseline on body mass index
Discharge from the gastroenterology clinic after achieving metabolic control goals	1 year	Difference in the percentage of patients discharged from the gastroenterology clinic after achieving metabolic control goals
Change on Fibrosis-4 Index	1 year	Change compared to baseline on Fibrosis-4 Index
Change on HDL- cholesterol	1 year	Change compared to baseline in the HDL- cholesterol (mg/dL)
Insulin resistance	1 year	In patients with insulin resistance, change compared to baseline on Insulin Resistance Index

Trial Locations

Locations (1)

Consorci Sanitari Alt Penedes i Garraf; 🇪🇸 Sant Pere De Ribes, Barcelona, Spain