NCT04895943进行中（未招募）不适用
Influence of Bariatric Endoscopy on Clinical Course of NAFLD
University Hospital Ostrava1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年4月29日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of patients with NAFLD with degree of fibrosis of the liver among patients undergoing bariatric endoscopy and to determine the influence of bariatric endoscopy on clinical course of NAFLD and liver fibrosis
研究概览
简要总结
Find out how bariatric endoscopy will influence the clinical course of non-alcoholic fatty liver disease.
详细描述
The study will test and investigate the impact of bariatric endoscopy (various types of intragastric balloons, endoscopic sleeve gastroplasty, aspiration therapy) on components of the metabolic syndrome in obese patients, especially on influencing non-alcoholic steatosis and steatohepatitis and signs of liver fibrotization and weight reduction. The method consists of performing a mini-invasive endoscopic procedure and, as a result, reduced food intake.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 21-70 years
- •BMI >27 Kg/m2
- •Must be able to comply with all study requirements for the duration of the study as outlined in the protocol. This includes complying with the visit schedule as well as study-specific procedures such as clinical assessment, endoscopy, radiography, as well as laboratory investigations
- •Must be able to understand and be willing to provide written informed consent
- •Patient living within radio range 300 km from the study center
- •Failure of the cognitive-behavioral approach to weight reduction
排除标准
- •Subjects meeting any of the following exclusionary criteria cannot be enrolled in the study:
- •History of gastric surgery.
- •Previous technical difficulties in gastric and duodenal endoscopy or inability to perform endoscopy
- •History of GIT diseases such as achalasia, esophageal motility disorders, severe esophagitis or gastritis, the recent history of ulcers, history of steatosis or obstruction in the GIT
- •Proven celiac disease
- •Previous irreversible endoscopic procedures and surgical treatment of obesity
- •Chronic and acute pancreatitis
- •Active or chronic infectious hepatitis
- •Known liver disease or suspected PBC, PSC, autoimmune hepatitis, alpha1-antitrypsin deficiency, Wilson's disease, hereditary hemochromatosis, known cirrhosis or history of hepatic decompensation, AST or ALT> 5-8x ULN
- •Type 1 or type 2 diabetes with insulin
- •History of malignant disease
- •Specific genetic or hormonal disorders associated with obesity (Prader-Willi syndrome, MC4R mutations, etc.)
- •Serious disorders of blood clotting and hematopoiesis
- •Severe forms of psychiatric illness (endogenous depression, schizophrenia, suicidal tendencies, psychosis)
- •Uncontrolled hypertension (systolic BP> 150 mm Hg or diastolic BP> 100 mm Hg) or severe heart disease (severe cardiac dysfunction, etc.)
- •Serious autoimmune diseases or long-term use treated with glucocorticoids or immunosuppressive therapy
- •Disorders of thyroid function unresponsive to processing.
- •Renal impairment with GFR <60 ml / min / 1.73 m2, or albumin excretion> 1000 mg / day
- •Substance use including excessive alcohol use (> 21 units / week for men and> 14 units / week for women, - 1 unit (250ml 12 ° or 330ml 10 ° beer; 100ml wine; 25ml = small spirits of spirits))
- •Pregnancy
结局指标
主要结局
Number of patients with NAFLD with degree of fibrosis of the liver among patients undergoing bariatric endoscopy and to determine the influence of bariatric endoscopy on clinical course of NAFLD and liver fibrosis
时间窗: 24 months
Number of patients with NAFLD with degree of fibrosis of the liver among patients undergoing bariatric endoscopy and to determine the influence of bariatric endoscopy on clinical course of NAFLD and liver fibrosis
次要结局
- Influence of bariatric endoscopy on change of anthropometric parameters(24 months)
- Influence of bariatric endoscopy on change of weight(24 months)
- Anthropometric changes - waist and hip circumference (cm)(24 months)
- Components of the metabolic syndrome - waist circumference (cm)(24 months)
- Components of the metabolic syndrome - blood pressure (mm/Hg)(24 months)
- Components of the metabolic syndrome - triacylglycerol levels (mmol/l), HDL cholesterol levels (mmol/l), glycemia (mmol/l)(24 months)
- Nutritional changes (eating habits) - questionnaire survey.(24 months)
- Anthropometric changes - weight (kg), BMI (kg/m2)(24 months)
研究者
研究点 (1)
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