EndoBarrier Register Deutschland
试验速览
- 阶段
- 不适用
- 入组人数
- 1,000
- 试验地点
- 11
- 主要终点
- Reduction of HbA1C
研究概览
简要总结
The purpose of this study ist to determine long-term safety and efficacy in weight reduction and improvement of diabetes mellitus of the temporary, endoscopic duodenal-jejunal bypass-sleeve EndoBarrier® in a national registry.
详细描述
Long-term data are collected by approximately 30 German centers. An electronic Case-Report-Form (eCRF) was designed to collect relevant pre-specified items by the Clinical Trial Center North (CTC). All German sites that have implanted EndoBarrier® since 2010 were invited to provide patient results. Data-acquisition is projected to a period of 5 years and a maximum of 1000 patients. An extension of data-acquisition is planned.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •clinical decision for treatment with EndoBarrier
- •informed consent for registry participation
排除标准
- •Patients not meeting the inclusion criteria
- •age < 18
结局指标
主要结局
Reduction of HbA1C
时间窗: From Implantation to at least 2 years follow up
Reduction of Antidiabetic Medication
时间窗: From Implantation to at least 2 years follow up
Excess weight loss
时间窗: From Implantation to at least 2 years follow up
Reduction of BMI
时间窗: From Implantation to at least 2 years follow up
Weight reduction
时间窗: From Implantation to at least 2 years follow up
次要结局
- Number of participants with treatment-related adverse events(From Implantation to at least 2 years follow up)
- Improvement of subjective Arthropathia(From Implantation to at least 2 years follow up)
- Smoking Status(From Implantation to at least 2 years follow up)
- Time of implantation and explantation(From Implantation to at least 2 years follow up)
- Reduction of fasting glucose(From Implantation to at least 2 years follow up)
- Reduction of fasting insulin(From Implantation to at least 2 years follow up)
- Reduction of fasting C-Peptide(From Implantation to at least 2 years follow up)
- Reduction of systolic blood pressure(From Implantation to at least 2 years follow up)
- Reduction of diastolic blood pressure(From Implantation to at least 2 years follow up)
- Reduction of antihypertensive medication(From Implantation to at least 2 years follow up)
- Reduction of total cholesterol(From Implantation to at least 2 years follow up)
- Reduction of LDL-cholesterol(From Implantation to at least 2 years follow up)
- Increase of HDL-cholesterol(From Implantation to at least 2 years follow up)
- Reduction of fasting triglycerides(From Implantation to at least 2 years follow up)
- Reduction of antihyperlipidemic medication(From Implantation to at least 2 years follow up)
- Reduction of 25OHD3(From Implantation to at least 2 years follow up)
- Reduction of Calcium(From Implantation to at least 2 years follow up)
- Reduction of Ferritin(From Implantation to at least 2 years follow up)
- Reduction of Hemoglobin(From Implantation to at least 2 years follow up)
- Reduction of Vitamin B12(From Implantation to at least 2 years follow up)
- Reduction of Albumin(From Implantation to at least 2 years follow up)
- Reduction of Folic acid(From Implantation to at least 2 years follow up)
- Reduction of Vitamin B1(From Implantation to at least 2 years follow up)
- Reduction of Vitamin B6(From Implantation to at least 2 years follow up)
- Reduction of CK(From Implantation to at least 2 years follow up)
- Reduction of AST(From Implantation to at least 2 years follow up)
- Reduction of ALT(From Implantation to at least 2 years follow up)
- Reduction of hsCRP(From Implantation to at least 2 years follow up)
- Duration of implantation process of the EndoBarrier in minutes(From Implantation to at least 2 years follow up)
- Duration of ithe explantation process of the EndoBarrier in minutes(From Implantation to at least 2 years follow up)
- Reduction of waist circumference(From Implantation to at least 2 years follow up)
- Reduction of daily caloric intake(From Implantation to at least 2 years follow up)