NCT03130244进行中（未招募）不适用
A Trial for a Procedure for Duodenum to Ileal Diversion to Treat Type 2 Diabetes
GI Windows, Inc.2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2019年9月23日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Mean change in HbA1c
研究概览
简要总结
Study will monitor changes in HbA1c for subjects in Intervention arm vs control arm.
详细描述
Randomized, Single-Center, Parallel-group, Open-label Pilot Study to Evaluate the Safety and Effectiveness of the GI Windows Magnet Anastomosis System (MAS) When Used to Create a Dual-path Enteral Diversion Compared with Medical Therapy Alone To Effect Glycemic Control in Obese Patients with Type 2 Diabetes Mellitus (T2DM)
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index (BMI) 30 to
- •Subject Type 2 Diabetes Criteria:
- •T2DM diagnosis ≥6 months but < 10 years
- •On 1 or more oral diabetes medications (with one at the minimum recommended therapeutic dose)
- •Hemoglobin A1C (HbA1c) between and including 6.5 and 10.0% (58 mmol/mol to 86 mmol/mol) at time of enrollment and has had a stable HbA1c over a 3-month period (i.e., <0.3% reduction)
- •Stable medication regimen (i.e., no change in diabetes medications) for at least 3 months prior to Screening Visit.
- •If subject has obesity-related comorbidities such as hypertension, dyslipidemia, and sleep apnea, these comorbidities must be well-controlled.
- •Able to understand and sign informed consent document
- •Has primary care physician and/or endocrinologist who follows patient for all comorbid conditions
排除标准
- •Known or suspected allergy to nickel or titanium or Nitinol
- •Type 1 Diabetes
- •Use of injectable insulin
- •Uncontrolled T2DM Fasting glucose ≥ 200 mg/dl (11.1 mmol/L)
- •Probable insulin production failure, defined as fasting serum C Peptide <1 ng/mL (0.3 nmol/l)
- •Any documented conditions for which endoscopy/colonoscopy would be contraindicated.
- •Contraindication to general anesthesia
- •Congenital or acquired anomalies of the GI tract, including atresias, stenosis or malrotation.
- •Any previous major surgery on the stomach (excluding sleeve gastrectomy), duodenum, hepatobiliary tree (excluding gallbladder), pancreas or right colon.
- •Previous technically difficult or failed colonoscopy or endoscopy
- •If on metformin, history of polycystic ovarian syndrome (PCOS)
- •Unable or unwilling to perform home blood glucose monitoring
- •History of or suspected gastrointestinal disease (e.g. cirrhosis, inflammatory bowel disease)
- •Diagnosis of active malignancy (i.e. not in remission) with the exception of squamous or basal cell carcinoma of the skin
- •Previous surgical or endoscopic treatment for obesity including but not restricted to intragastric balloons, endoscopic suturing or stapling procedures, malabsorptive sleeves.
- •Specific genetic or hormonal cause of obesity (e.g. Prader-Willi syndrome)
研究组 & 干预措施
Device Placement
Active Comparator
The patients in this arm will receive the Magnet Anastomosis System and an anastomosis will be created.
干预措施: Magnet Anastomosis System (Device)
Device Placement
Active Comparator
The patients in this arm will receive the Magnet Anastomosis System and an anastomosis will be created.
干预措施: Best Medical Management (Drug)
结局指标
主要结局
Mean change in HbA1c
时间窗: 12 months
The primary effectiveness endpoint is Mean change in HbA1c from baseline
次要结局
- Mean change in Weight(12 months)
- Proportion of subjects achieving remission(12 months)
- Mean change in diabetes medication(12 months)
研究者
研究点 (2)
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