NCT07376486招募中不适用
Duodenal Recellularization Via Electroporation Therapy as an Early Treatment for Type 2 Diabetes Mellitus (DREAM-1 Study)
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- HbA1c ≤6.5% without glucose lowering drugs
研究概览
简要总结
This study is designed to evaluate the efficacy and safety of endoscopic duodenal re-cellularization therapy using pulsed electric field in individuals with in patients with a recent diagnosis of type 2 diabetes mellitus (T2DM).
详细描述
This is a prospective, single-armed, feasibility study enrolling individuals with a recent diagnosis of type 2 diabetes. Participants will be followed for 6 months for the primary endpoint and 2 years in total.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Duration of T2DM </= 2 years
- •HbA1c </= 7.5%
- •On 0-1 oral diabetes medications
排除标准
- •Previous treatment with pulsENDO or similar procedure
- •Previous GI surgery that could preclude the ability to perform pulsENDO, or acute gastric and duodenal pathology that increased the risk of pulsENDO
- •Type I 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 or antiplatelet 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
- •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
Endoscopic duodenal recellularization via electroporation therapy (pulsENDO)
Experimental
pulsENDO procedure entails the ablation of the duodenal mucosa with irreversible electroporation (IRE)
干预措施: pulsENDO treatment (Procedure)
结局指标
主要结局
HbA1c ≤6.5% without glucose lowering drugs
时间窗: 6 months post-procedure
Proportion of participants with HbA1c ≤6.5% without glucose lowering drugs
次要结局
- HbA1c(24 months post-procedure)
- Total body weight loss (%TBWL)(24 months post-procedure)
- Incidence of adverse events(within 30 days post-procedure)
- Body fat percentage(24 months post-procedure)
- Change in Quality of Life(24 months post-procedure)
- Hepatic steatosis index(24 months post-procedure)
研究者
Stephen KK Ng
Principal Investigator
Chinese University of Hong Kong
研究点 (2)
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