An Open-label, Randomized, Controlled Clinical Trial on the Effects of Endoscopic Sleeve Gastroplasty on Weight, Metabolic Risk Factors, Quality of Life, Satiety, Gastrointestinal Motility and Gut Microbiota
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Total body weight loss
研究概览
简要总结
This is an interventional, open-label, randomized (2:1), standard medical therapy-controlled trial.
Subjects in the standard therapy group will be given the opportunity to undergo the active endoscopic treatment after 6 months of follow up (open label extension) if they will not achieve an adequate result on body weight. All patients will be followed until the planned end of the study after 36 months from the ESG procedure.
To study the effects of endoscopic gastroplasty on weight, metabolic risk factors, quality of life, satiety, gastrointestinal motility and gut microbiota compared to standard medical treatment control group.
Primary endpoint:
- Total body weight loss (%)
Secondary endpoints:
- Metabolic risk factors (e.g. lipid profile) and anthropometric measurements (e.g hip and waist circumference)
- Body composition
- Quality of life
- Gastroesophageal reflux disease
- Non-Alcoholic Fatty Liver Disease (NAFLD)
- Non- Alcoholic-Steato-Hepatitis (NASH)
- Satiety
- Gut microbiota
Exploratory endpoints:
- Gut hormones e.g. glucagon-like peptide 1, PYY and ghrelin
- Gastrointestinal motility
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participants have to fulfill the following criteria for participating in the study:
- •Age 20 to 65 years
- •BMI between 30 to 45 kg/m2
- •Willingness to participate in the study and ability to comply and understand the study protocol
排除标准
- •Active gastric ulcer during the last 6 months
- •Organic or motility disorder of the stomach and / or esophagus
- •Anticoagulant treatment
- •Previous bariatric surgery or any other type of surgery of the esophagus, stomach and duodenum
- •Ongoing or active malignancy during the last 5 years
- •Myocardial infarction during the past 6 months or/and heart failure class III or IV according to the New York Heart association's classification
- •Drug or alcohol abuse
- •Bulimic or binge eating pattern
- •Continuous glucocorticoid or anti-inflammatory treatment
- •Uncontrolled thyroid disease
- •Pregnancy, breastfeeding
- •Psychiatric or cooperative problems or low compliance that is a contraindication from participating in the study
- •Hiatal hernia > 5 cm
- •Currently participating in other study
- •Any health issue that might put the patient at risk if the treatment is performed, judged by the investigator
研究组 & 干预措施
active endoscopic treatment
Patients that will undergo Endoscopic Sleeve Gastroplasty
干预措施: Endoscopic sleeve gastroplasty (Device)
standard medical therapy control diet group
Patients that will undergo diet
干预措施: Endoscopic sleeve gastroplasty (Device)
结局指标
主要结局
Total body weight loss
时间窗: 36 months
Total body weight loss (%) measurement in kg and BMI
次要结局
- Non-Alcoholic Fatty Liver Disease evaluation(12 months)
- performing of gastric emptying scintigraphy for gastrointestinal motility(Baseline and six months)
- Non- Alcoholic-Steato-Hepatitis evaluation(12 months)
- Gut microbiota characterization(6 months)
- Evaluation for Gastroesophageal reflux disease(12, 24, 36 months)
- Gut hormones e.g. glucagon-like peptide 1, PYY and ghrelin dosages(Baseline and 6 months)
研究者
BOSKOSKI IVO
MD, PhD
Fondazione Policlinico Universitario Agostino Gemelli IRCCS