NL-OMON51445撤回2 期
Endoscopic sutured gastroplasty with endomina in diabetic, obese patients * prospective interventional study - GATE-study
niversitair Medisch Centrum0 个研究点目标入组 40 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 入组人数
- 40
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 but diagnosed no longer than 10 years ago
- •o currently under stable dose of insulin for at least 6 months
- •- HbA1c level of 7.0-11.0% (53-75 mmol/mol)
- •- BMI of 30-40 kg/m² with or without hypertension
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
- •- Pregnancy, breast feeding or desire for pregnancy in the coming 12 months
- •- 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
研究者
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