Benefit of a Hospital Intervention in Patients With Hepatic Steatosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Specialized Unit, Usual Follow-Up.
- Who it may be relevant to
- Registry conditions: Hepatic Steatosis. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other Specialized Unit
The participant will be visited every three months for one year - Other Usual Follow-Up
The participant will be visited as usual, it means they will be visited at Digestive Consultation
Primary outcome measures
- Discharge criteria from the gastroenterology clinic [Time frame: 1 year]
Secondary outcome measures (12)
- Discharge from the gastroenterology clinic after achieving metabolic control goals [Time frame: 1 year]
- Change on Test de Owliver [Time frame: 1 year]
- Change on liver enzymes [Time frame: 1 year]
- Change on total cholesterol [Time frame: 1 year]
- Change on LDL- cholesterol [Time frame: 1 year]
- Change on HDL- cholesterol [Time frame: 1 year]
- Change on triglycerides [Time frame: 1 year]
- Change on Fibrosis-4 Index [Time frame: 1 year]
- Change on Hepatic Fibrosis [Time frame: 1 year]
- Glycated hemoglobin [Time frame: 1 yera]
- Insulin resistance [Time frame: 1 year]
- Body Mass Index [Time frame: 1 year]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
Spain · 1 center
- Consorci Sanitari Alt Penedes i Garraf — Sant Pere de Ribes
Identifiers
NCT: NCT06394206 · CSAPG-46