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Search / Trial NCT06394206

Benefit of a Hospital Intervention in Patients With Hepatic Steatosis

Launched by CONSORCI SANITARI DE L'ALT PENEDÈS I GARRAF · Apr 30, 2024

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Fatty Liver Metabolic Syndrome

ClinConnect Summary

This clinical trial is investigating whether a special consultation for managing metabolic syndrome can help adults with a condition called hepatic steatosis, or fatty liver disease. The main goal is to see if this consultation leads to more patients showing improvement in their liver health after one year. Researchers will look at important health indicators, such as liver test results, weight loss, and levels of cholesterol and triglycerides (fats in the blood), to measure any changes. Participants will be randomly placed into two groups: one will attend the specialized consultation every three months for a year, while the other will continue with their usual care without the specialized visits.

To be eligible for this trial, participants must be adults diagnosed with hepatic steatosis through imaging tests like ultrasounds or CT scans and have mild to moderate liver scarring. They should also be willing to sign consent to join the study. However, individuals with certain other health issues, recent imaging tests, or those who consume alcohol excessively are not eligible. This trial is not yet recruiting participants, but it represents an opportunity for those with hepatic steatosis to potentially receive additional support and care through specialized consultations.

Gender

ALL

Eligibility criteria

  • 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.

About Consorci Sanitari De L'alt Penedès I Garraf

Consorci Sanitari de l'Alt Penedès i Garraf is a leading healthcare consortium located in Catalonia, Spain, dedicated to providing high-quality medical services and advancing clinical research. With a commitment to innovation and patient-centered care, the consortium integrates various health services, including hospitals and specialized care facilities, to enhance health outcomes in the Alt Penedès and Garraf regions. By fostering collaboration among healthcare professionals and engaging in clinical trials, the consortium aims to contribute to the development of new therapies and improve the overall healthcare landscape.

Locations

Sant Pere De Ribes, Barcelona, Spain

Patients applied

0 patients applied

Trial Officials

Lidia Tikhomirova, MD

Principal Investigator

CSAPG

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported