Post Marketing Study in Subjects Who Have Type 2 Diabetes Using the EndoBarrier™ Gastrointestinal Liner
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 3
- 主要终点
- HbA1c (%) Measured at Week 52
研究概览
简要总结
The purpose of this study is to evaluate EndoBarrier Gastrointestinal Liner in the post marketing environment in subjects who are obese and have Type 2 Diabetes.
详细描述
Patients with obesity are at significantly greater risk of developing complications such as pulmonary dysfunction, diabetes, hypertension, and other co-morbid risks. NIH panel recommendations state that even a 10% short-weight loss would greatly reduce these risks. GI Dynamics' EndoBarrier represents a viable alternative to other short-term pre-surgical weight loss methods. EndoBarrier is a device that can be implanted and removed through minimal invasive endoscopic techniques. This endoscopic procedure brings potential benefits to patients in that it is minimally invasive, efficacious, and allows patients to recover faster with less morbidity and mortality
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects Age > 18 years and ≤65 years - Male or Female
- •Subjects with Type 2 Diabetes > 1 and ≤ 10 years in duration
- •Subjects with an Hb A1c level > 7.5 and ≤ 10.0
- •Subjects taking oral Type 2 Diabetes medications and/or insulin. Metformin is allowed, but not required.
- •Subjects with a BMI > 30 and< 50
- •Subjects willing to comply with study requirements
- •Subjects who have signed an informed consent form
- •Women who are post-menopausal, surgically sterile or on contraceptives and agree to remain on contraceptives for the duration of their study participation and agree not to become pregnant during the study.
排除标准
- •Subjects taking Inhibitors of dipeptidyl peptidase 4 inhibitors (ie. Januvia (sitagliptin), Galvus (vildagliptin) or incretins (ie. Byetta (exenatide), Victoza (liraglutide)
- •Subjects requiring insulin >150 units per day
- •Subjects with probable insulin production failure (fasting C Peptide serum <1.0 ng/mL)
- •Subjects diagnosed with Type 1 Diabetes Mellitus or having a history of ketoacidosis
- •Subjects requiring NSAIDs (non-steroidal anti-inflammatory drugs) or prescription anticoagulation therapy during the implant period
- •Subjects with or a history of iron deficiency and/or iron deficiency anemia
- •Subjects with or a history of abnormalities of the GI tract
- •Subjects with symptomatic gallstones or kidney stones at the time of screening
- •Subjects with a known infection
- •Subjects with or a history of coagulopathy, upper gastro-intestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasia
- •Subjects mentally retarded or emotionally unstable, or exhibits psychological characteristics which, in the opinion of the Investigator, makes the subject a poor candidate for device placement or clinical study participation
- •Subjects with previous GI surgery that could affect the ability to place the device or the function of the implant
- •Subjects with active H. pylori (Note: Subjects may be enrolled if they had a prior history of H. Pylori and were successfully treated. If Subjects have active H. pylori at baseline, they can receive appropriate treatment and then subsequently enroll to the study.)
- •Subject or Family history of a known diagnosis or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder
- •Subjects with active and uncontrolled gastroesophageal reflux disease (GERD)
- •Subjects with severe liver or kidney failure (serum creatinine >180mmol/l)
- •Subjects with poor dentition who can not adequately chew their food
结局指标
主要结局
HbA1c (%) Measured at Week 52
时间窗: 12 months
Total Weight Change From Baseline to Week 52
时间窗: 12 months
Total weight change at 12 months (kg) compared to baseline
Changes in Diabetic Medications at Treatment Completion Compared to Baseline
时间窗: 12 months
number of patients with a decrease, increase or no change in diabetic medications at time of EndoBarrier explantation (treatment completion)
Change From Baseline in SF 36v2 Quality of Life Assessment
时间窗: Baseline, 12 months (explant), 6 months post explant (18 months post baseline)
Quality of life was measured using Survey Form SF-36v2 licensed from Quality Metric, Inc (Lincoln, RI). Physical and Mental component scores were measured at baseline, month 12 (at the time of explant) and 6 months post explant with results self-recorded by each subject. The SF-36 v2 physical component summary (PCS) score as well as the mental component summary score (MCS) ranged between 0 and 100, with higher scores reflecting better quality of life in each case.
次要结局
未报告次要终点