Benefit of a Hospital Intervention in Patients With Hepatic Steatosis

Обзор

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.

Вмешательства

• Другое Specialized Unit
  The participant will be visited every three months for one year
• Другое Usual Follow-Up
  The participant will be visited as usual, it means they will be visited at Digestive Consultation

Первичные конечные точки

• Discharge criteria from the gastroenterology clinic [Срок оценки: 1 year]

Вторичные конечные точки (12)

• Discharge from the gastroenterology clinic after achieving metabolic control goals [Срок оценки: 1 year]
• Change on Test de Owliver [Срок оценки: 1 year]
• Change on liver enzymes [Срок оценки: 1 year]
• Change on total cholesterol [Срок оценки: 1 year]
• Change on LDL- cholesterol [Срок оценки: 1 year]
• Change on HDL- cholesterol [Срок оценки: 1 year]
• Change on triglycerides [Срок оценки: 1 year]
• Change on Fibrosis-4 Index [Срок оценки: 1 year]
• Change on Hepatic Fibrosis [Срок оценки: 1 year]
• Glycated hemoglobin [Срок оценки: 1 yera]
• Insulin resistance [Срок оценки: 1 year]
• Body Mass Index [Срок оценки: 1 year]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Испания · 1 центр

• Consorci Sanitari Alt Penedes i Garraf — Sant Pere de Ribes

Идентификаторы

NCT: NCT06394206 · CSAPG-46

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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