Clinical trial NCT06394206: Benefit of a Hospital Intervention in Patients With Hepatic Steatosis
Official title: Benefit of a Hospital Intervention in Patients With Hepatic Steatosis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hepatic Steatosis
Keywords: Fatty Liver
Metabolic Syndrome
Lead sponsor: Consorci Sanitari de l'Alt Penedès i Garraf
Sponsor class: OTHER
First posted: 2024-05-01
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Discharge criteria from the gastroenterology clinic
timeFrame: 1 year
Secondary outcomes:
measure: Discharge from the gastroenterology clinic after achieving metabolic control goals
timeFrame: 1 year
measure: Change on Test de Owliver
timeFrame: 1 year
measure: Change on liver enzymes
timeFrame: 1 year
measure: Change on total cholesterol
timeFrame: 1 year
measure: Change on LDL- cholesterol
timeFrame: 1 year
measure: Change on HDL- cholesterol
timeFrame: 1 year
measure: Change on triglycerides
timeFrame: 1 year
measure: Change on Fibrosis-4 Index
timeFrame: 1 year
measure: Change on Hepatic Fibrosis
timeFrame: 1 year
measure: Glycated hemoglobin
timeFrame: 1 yera
measure: Insulin resistance
timeFrame: 1 year
measure: Body Mass Index
timeFrame: 1 year
Other outcomes:
Locations:
city: Sant Pere De Ribes
country: Spain
facility: Consorci Sanitari Alt Penedes i Garraf
state: Barcelona
Study officials:
affiliation: CSAPG
name: Lidia Tikhomirova, MD
role: PRINCIPAL_INVESTIGATOR
References: