NCT07317115招募中不适用
Magnetic Compression Anastomosis in Side-to-Side Duodeno-ileostomy Versus Semaglutide in Adults With Obesity and Type 2 Diabetes (MAGvMED 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
- 主要终点
- Functional improvement of T2D: HbA1c
研究概览
简要总结
Compare use of the Magnet System in side-to-side duodeno-ileostomy (Surgery) with semaglutide (Medication).
详细描述
Compare functional improvement of T2D using the Magnet System in duodeno-ileostomy for intestinal diversion versus semaglutide in eligible participants with obesity (BMI 30 - 40 kg/m2) and T2D (HbA1c ≥ 6.5%).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body Mass Index (BMI) between 30 - 40 kg/m2 and qualifies for obesity treatment at the discretion of the treating investigator (i.e., must be assessed to qualify for both surgery and medication treatment to justify randomization).
- •Type 2 diabetes (T2D defined as HbA1c ≥ 6.5%).
- •Participant agrees to refrain from additional metabolic and bariatric (MBS) or reconstructive surgery that would affect body weight for the duration of the study.
- •Participant agrees to refrain from taking any additional semaglutide-containing or other GLP-1RA medication for the duration of the study, regardless of randomization assignment (i.e., Surgery or Medication).
- •Participant has been informed of the nature of the study and is willing and able to comply with requirements, including randomization, and provides written informed consent to participate in the study.
排除标准
- •Meets any of the contraindications for either treatment arm (Surgery: Magnet System; or Medication: semaglutide), thereby prohibiting randomization
- •Current or previous metabolic and bariatric surgery (MBS) treatment in the previous 12 months (e.g., sleeve gastrectomy, intragastric balloons, adjustable gastric banding).
- •Taking or treated with semaglutide, semaglutide-containing medications, or any other GLP-1RA medication in the previous 12 months.
- •Pregnant, lactating or planning pregnancy during the clinical study and follow-up period.
- •Currently participating in an investigational drug, biologic, or medical device or other interventional clinical study.
- •Presence of other anatomic or comorbid conditions, or medical, social or psychological conditions that, in the investigator's opinion, would contraindicate either treatment arm or could limit the participant's ability to participate in the clinical study or to comply with follow-up requirements.
研究组 & 干预措施
Surgery Arm
Active Comparator
Magnet System
干预措施: Magnet System (Device)
Medication Arm
Active Comparator
Semaglutide
干预措施: Semaglutide (Drug)
结局指标
主要结局
Functional improvement of T2D: HbA1c
时间窗: Day 360
次要结局
未报告次要终点
研究者
研究点 (1)
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