A Pilot Trial of the EndoBarrier™ Flow Restrictor for Glycemic Improvement in Type 2 Diabetics
2011年8月5日 更新者:GI Dynamics
The main objective of the study is to demonstrate the safety and efficacy of the EndoBarrier Flow Restrictor in the glycemic control of diabetes in subjects with Type 2 diabetes.
The primary efficacy endpoint is an assessment of glycemic control at week 24 or last assessment measured via HbA1c.
研究概览
地位
完全的
条件
研究类型
观察性的
注册 (预期的)
50
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
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Santiago、智利
- Hospital Universidad Catolica
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 55年 (成人)
接受健康志愿者
是的
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Subjects with Type 2 Diabetes
描述
Inclusion Criteria:
- Age > 18 years and < 55 years - Male or Female
- BMI > 30 BMI <60
- Subjects with an HbA1c > 7.5 and ≤ 10.0%
- Subjects with Type 2 diabetes who have been treated for ≤10 years
- Subjects on Metformin and/or Sulfonylurea
- History of failure with nonsurgical weight loss methods
- Subjects willing to comply with trial requirements
- Subjects who have signed an informed consent form
- Women who are post-menopausal, surgically sterile or on oral contraceptives and who do not plan on becoming pregnant during the course of the trial.
Exclusion Criteria:
- Treatment represents an unreasonable risk to the subject
- Subjects on oral diabetic medications other than Metformin or Sulfonylurea
- Subjects on insulin
- Subjects diagnosed with Type 1 Diabetes Mellitus or having a history of ketoacidosis
- Subjects with a past medical history of hypoglycemia
- Subjects with abnormal gastric emptying at baseline, defined as < 90% stomach emptied at 4 hours
- Subjects with a weight loss of > 4.5 Kg (10 lbs) within the 12 Weeks of screening
- Subjects taking corticosteroids or drugs known to affect GI motility (i.e. Reglan)
- Pregnant or have intention of becoming pregnant for the duration of the trial
- Unresolved alcohol or drug addiction
- Subjects receiving weight loss medications (prescription, over-the-counter, or herbal dietary medications)
- Previous gastrointestinal surgery that could affect the ability to place the EndoBarrier Flow Restrictor or the function of the implant.
- Subjects with active and uncontrolled GERD
- Subjects with symptomatic kidney stones prior to implant
- Subjects with iron deficiency and/or iron deficiency anemia
- History of Inflammatory bowel disease or condition of the gastrointestinal tract, such as ulcers or Crohn's disease
- Subjects with symptomatic gallstones prior to implant
- Symptomatic coronary artery disease or pulmonary dysfunction
- Known infection (Subjects who have a known infection at time of screening can be enrolled if the infection is treated prior to their procedure; if they still have an infection on day of procedure they must be withdrawn)
- History of congenital or acquired anomalies of the gastrointestinal tract such as atresias or stenoses
- Pancreatitis or other serious organic conditions
- Subjects requiring prescription anticoagulation therapy
- Subjects unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) during the implant period
- Subject or Family history of a known diagnosis or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder
- Participating in another ongoing investigational clinical trial
- Mentally retarded or emotionally unstable, or exhibits psychological characteristics requiring medication that affects appetite (i.e. tricyclic antidepressants and atypical antipsychotic medications) which, in the opinion of the Investigator, makes the subject a poor candidate for device placement or clinical trial.
- Subjects with active H. pylori (Note: Subjects may be enrolled if they had a prior history of H. Pylori and were successfully treated or are diagnosed during baseline tests and undergo successful treatment before their procedure)
- Subjects with or a history of coagulopathy, upper gastro-intestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasia
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
The primary efficacy endpoint is an assessment of glycemic control at week 24 or last assessment measured via HbA1c.
大体时间:24 weeks
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24 weeks
|
次要结果测量
结果测量 |
大体时间 |
---|---|
The safety endpoint will be the incidence and severity of anticipated and unanticipated adverse events (device and non-device related).
大体时间:24 weeks
|
24 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
调查人员
- 首席研究员:Alex Escalona, MD、Hospital Universidad Catolica
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2009年9月1日
初级完成 (实际的)
2010年6月1日
研究完成 (实际的)
2010年12月1日
研究注册日期
首次提交
2009年9月6日
首先提交符合 QC 标准的
2009年9月8日
首次发布 (估计)
2009年9月9日
研究记录更新
最后更新发布 (估计)
2011年8月8日
上次提交的符合 QC 标准的更新
2011年8月5日
最后验证
2011年8月1日
更多信息
与本研究相关的术语
其他研究编号
- 09-2
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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