About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Specialized Unit
Other interventionThe participant will be visited every three months for one year
Usual Follow-Up
Other interventionThe participant will be visited as usual, it means they will be visited at Digestive Consultation
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
Discharge from the gastroenterology clinic after achieving metabolic control goals
Difference in the percentage of patients discharged from the gastroenterology clinic after achieving metabolic control goals
Change on Test de Owliver
Change in the Owliver test compared to baseline
Change on liver enzymes
Change compared to baseline in the liver enzymes (UI/mL)
Change on total cholesterol
Change compared to baseline in the total cholesterol (mg/dL)
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: