NCT04627103已完成不适用
A Trial for a Procedure for Duodenal-Ileal Diversion With a Sleeve Gastrectomy for Patients With Obesity and Type 2 Diabetes Mellitus
GI Windows, Inc.4 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2021年10月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 4
- 主要终点
- Weight Loss
研究概览
简要总结
Study will monitor weight loss and metabolic indicators for subjects in multi-center, single arm trial.
详细描述
Multi-Center, Open-label Pilot Study to Evaluate the Safety and Effectiveness of the GI Windows Single Neodymium Magnet Anastomosis Procedure When Used to Create a Duodenal-Ileal Diversion with a Sleeve Gastrectomy (SNAP-S) for Subjects with Obesity and Type 2 Diabetes Mellitus (T2DM)
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
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 19-65 years at screening
- •Body mass index (BMI) ≥35 and ≤50
- •T2DM diagnosis ≥6 months but < 10 years, with 1 or more oral diabetes medications, HbA1c ≥ 6.5% but < 10.0% at time of enrollment.
- •HbA1c must be stable over a 3-month period.
- •Weight stable over 3-month period
- •Obesity-related comorbidities (hypertension, dyslipidemia, sleep apnea) must be well-controlled
- •Agrees to refrain from any type of additional bariatric or reconstructive surgery that would affect body weight for a duration of 2 years
- •If female, subject must commit to not becoming pregnant for 24 months and agree to use contraception during this period
- •Able to understand and sign informed consent documents.
排除标准
- •Known or suspected allergy to nickel or titanium or nitinol
- •Type 1 diabetes or poorly controlled type 2 diabetes
- •Use of injectable insulin
- •Any documented conditions for which endoscopy would be contraindicated
- •Contraindication to general anesthesia
- •History of chronic gastrointestinal disease
- •Congenial or acquired anomalies of the GI tract
- •Any previous major surgery on the stomach, duodenum, hepatobiliary tree (excluding gallbladder), pancreas, or right colon.
- •Uncontrolled hypertension
- •Pre-existing severe comorbid cardio-respiratory disease
- •History of chronic gastrointestinal disease
- •Specific genetic or hormonal cause of obesity
- •Recent tobacco/nicotine product cessation (within 3 months prior)
结局指标
主要结局
Weight Loss
时间窗: 12 months
Weight loss measured as a percent of total body weight (TBW)
次要结局
- Liver Changes using Fibroscan(12 months)
- Excess Weight Loss Measures(12 months)
- Absolute Weight Loss Measures(12 months)
- Diabetes Medication Dosage and Frequency Changes(12 months)
- Blood Pressure Changes(12 months)
- Albumin - Nutritional Status(12 months)
- Percent Responders(12 months)
- Hemoglobin A1c(12 months)
- Serum Lipids(12 months)
- Diabetes Remission and/or Improvements(12 months)
- BMI - Weight Loss Measures(12 months)
- Fasting Glucose(12 months)
- Nutritional Status(12 months)
研究者
研究点 (4)
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