NL-OMON53331尚未招募不适用
The GATE trial: Endoscopic sutured Gastroplasty in Type 2 diabetic, obese patients using the Endomina device - a randomized controlled trial, and its effect on incretin hormones - GATE trial
niversitair Medisch Centrum0 个研究点目标入组 58 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 58
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •- Age between 18-65 years
- •- Diagnosed with DM2
- •o since at least 1 year
- •o currently under stable dose of insulin for at least 6 months
- •o with or without use of any other oral glucose lowering medication (e.g.,
- •metformin, GLP-1 receptor agonist)
- •- HbA1c level of 7.0-11.0% (53-75 mmol/mol) prior to inclusion
- •- BMI of 30-40 kg/m²
- •- The maximum attainable therapeutic options within standard reimbursed care
- •are obtained (e.g., lifestyle intervention like GLI or dietician and
- •pharmacotherapeutic options like sulfonylureas, metformin, SLGT2 inhibitors,
- •GLP1 agonists and insulin).
- •- Must be eligible for general anesthesia or deep sedation with propofol
排除标准
- •Achalasia and any other esophageal motility disorders
- •Severe esophagitis (grade C or D)
- •Gastro-duodenal ulcer
- •GI stenosis or obstruction
- •Any history of esophageal or gastric surgery
- •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
- •Uncontrolled hypertension (systolic blood pressure >180 mm Hg and/or
- •diastolic blood pressure >100 mm Hg under medication) during last 3 months;
- •Severe renal, hepatic, pulmonary disease or cancer (cancer in the past 5
- •years, except basal cell carcinoma)
- •Known with, or history of, eating disorder
- •Pregnancy, breast feeding or desire to become pregnanct in the coming 12
- •Any previous bariatric surgery, or endoscopic obesity-related intervention
- •(including POSE, OverStitch, etc.). Intragastric balloon removed within the
- •last 6 months
- •Planned gastric surgery 60 days post intervention
- •Anticoagulant therapy that cannot be temporarily stopped at the time of the
- •Currently participating in another study (involving change of treatment).
研究者
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