Benefit of a Hospital Intervention in Patients With Hepatic Steatosis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Discharge criteria from the gastroenterology clinic
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •Signature of informed consent for study inclusion, either by the participant themselves or by their legal representative.
排除标准
- •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.
结局指标
主要结局
Discharge criteria from the gastroenterology clinic
时间窗: 1 year
Percentage of patients meeting discharge criteria (defined by the trial) from the gastroenterology clinic at the end of the study
次要结局
- Change on total cholesterol(1 year)
- Change on triglycerides(1 year)
- Change on liver enzymes(1 year)
- Change on LDL- cholesterol(1 year)
- Change on Hepatic Fibrosis(1 year)
- Change on Test de Owliver(1 year)
- Glycated hemoglobin(1 yera)
- Body Mass Index(1 year)
- Discharge from the gastroenterology clinic after achieving metabolic control goals(1 year)
- Change on Fibrosis-4 Index(1 year)
- Change on HDL- cholesterol(1 year)
- Insulin resistance(1 year)