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临床试验/NCT04669470
NCT04669470Unknown不适用

Influence of Bariatric Endoscopy on Clinical Course of NAFLD

University of Ostrava2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年10月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
2
主要终点
Amount of patients with NAFLD with degree of fibrosis of the liver amog patients undergoing bariatric endoscopy and determine influence of bariatric endoscopy on clinical course of NAFLD and liver fibrosis

研究概览

简要总结

Find out how bariatric endocopy will influence 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 in performing a mini-invasive endoscopic procedure and, as a result, in reduced food intake.

Current state of knowledge:

Based on data evaluated according to EBM (Evidence Based Medicine), it is an indisputable fact that bariatric methods have a demonstrable effect not only on improving the parameters and regression of many metabolic syndromes, but also improve the course of non-alcoholic fatty liver disease (NAFLD). It is this nosological unit that is becoming the dominant cause of liver disease in developed countries and has two subunits, where simple hepatic steatosis (NAFL) is considered a benign disease, while the second, where fat accumulation in the liver is associated with the inflammatory process called non-alcoholic steatohepatitis (NASH). ) has serious consequences for the liver with the development of fibrotization leading to cirrhosis with all its adverse effects. Recently, however, it has been shown that even simple steatosis is not as benign as it seemed, but carries an independent risk for the patient due to an increased incidence of cardiovascular diseases, oncological manifestations and a higher incidence of metabolic syndrome manifestations. Classical bariatric endoscopy carries a number of risks associated with the patient for the surgical procedure, however, we also have less invasive methods of gradually more and more developing endoscopy and dreams of associated bariatric procedures with many times lower risk for the patient.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • To be eligible for participation in this study, subjects must conform to the following inclusion criteria:
  • Age between 21-64 years;
  • BMI >30 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.

排除标准

  • Subjects meeting any of the following exclusionary criteria cannot be enrolled in the study:
  • Achalasia and any other esophageal motility disorders
  • Heart diseases: unstable angina, myocardial infarction within the past year, or heart disease classified within the New York Heart Association's Class III or IV functional capacity.
  • Hypertension: uncontrolled hypertension during last 3 month
  • Severe renal, hepatic, pulmonary disease or cancer;
  • GIT stenosis or obstruction
  • Pregnancy or breastfeeding
  • Impending gastric surgery 60 days post intervention;
  • Currently participating in other study
  • Celiac disease
  • History of bariatric surgery
  • Chronic or recent acute pancreatitis
  • Type 2 diabetes with insuline medication or type 1 diabetes
  • Hematologic disease or disease with impairment of hemocoagulation
  • Decompensated psychiatric disease
  • Autoimmune disease with chronic glucocorticoid or imunosupressive medications
  • Uncontroled disease of thyroid gland
  • Excesive abuse of addictive substances such alcohol or other

结局指标

主要结局

Amount of patients with NAFLD with degree of fibrosis of the liver amog patients undergoing bariatric endoscopy and determine influence of bariatric endoscopy on clinical course of NAFLD and liver fibrosis

时间窗: 24 months

Amount of patients with NAFLD with degree of fibrosis of the liver amog patients undergoing bariatric endoscopy and determine influence of bariatric endoscopy on clinical course of NAFLD and liver fibrosis

次要结局

  • Influence of bariatric endoscopy on improvements of weight, antropometric, improvements in components of metabolic syndrome(24 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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Bariatric Endoscopy and NAFLD | 临床试验