NCT07660445招募中不适用
Integrating Duodenal Recellularization Via Electroporation Therapy and Endoscopic Sleeve Gastroplasty as a Novel Approach to Managing Diabesity (DRAGON Study)
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
研究概览
简要总结
This study is designed to evaluate the efficacy, safety, and mechanisms of combining ESG and pulsENDO procedure in obese patients with T2DM
详细描述
This is a prospective, single-armed, feasibility study enrolling individuals with obesity and type 2 diabetes. Participants will be followed for a total of 2 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •BMI >/= 27kg/m2
- •Known T2DM
- •Individualized Metabolic Surgery (IMS) score 25-115
- •HbA1c <11% (subjects on oral glucose lowering drug(s) or HbA1c <8% (subjects on insulin)
排除标准
- •Previous treatment with ReCET, ESG or similar procedure
- •Previous GI surgery that could preclude the ability to perform ReCET or ESG, or acute gastric and duodenal pathology that increased the risk of ReCET or ESG
- •Type 1 DM, DM secondary to specific disease or having any history of ketoacidosis
- •Fasting C-peptide level <0.5ug/L
- •Any inflammatory disease of the gastrointestinal tract such as Crohn's disease
- •Abnormal pathologies or conditions of the gastrointestinal tract, including duodenal polyps, ulcers or upper gastrointestinal bleeding conditions within 3 months of study
- •Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count less than 100,000/microliter or known coagulopathy
- •Currently taking prescription antithrombotic therapy (e.g., anticoagulant agent) within 10 days prior to study and/or there is a need or expected need to use during the study period
- •Currently taking medications known to cause significant weight gain or weight loss (e.g. chemotherapeutics)
- •Patients who have used non-steroidal analgesics and anti-inflammatory drugs (NSAID) and corticosteroids in the past 1 month
- •Underlying uncontrolled endocrine problem that leads to obesity, including and not limited to hypothyroidism, Cushing syndrome and eating disorder.
- •Patients with contra-indications to endoscopy
- •Patients with cirrhosis due to causes other than MASLD
- •Malignancy
- •Diagnosis of autoimmune connective tissue disorder (e.g. lupus erythematosus, scleroderma)
- •Pregnant or breast feeding
- •ASA grade IV & V
- •Mental or psychiatric disorder; Drug or alcohol addiction
- •Other cases deemed by the examining physician as unsuitable for safe treatment
- •Refusal to participate
研究组 & 干预措施
ESG plus duodenal pulsENDO
Experimental
ESG and pulsENDO procedure will be performed in same session
干预措施: Endoscopic sleeve gastroplasty plus duodenal recellularization via electroporation therapy (pulsENDO) (Procedure)
研究者
Stephen KK Ng
Principal Investigator
Chinese University of Hong Kong
研究点 (1)
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