此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Safety and Efficacy of EndoBarrier in Subjects With Type 2 Diabetes Who Are Obese (ENDO)

2016年12月2日 更新者：GI Dynamics

A Randomized, Multi-Center, Pivotal Efficacy and Safety Study Comparing the EndoBarrier Gastrointestinal Liner System vs. Sham for Glycemic Improvement in Inadequately Controlled Obese Type 2 Diabetic Subjects on Oral Anti-Diabetes Agents

To determine if the EndoBarrier safely and effectively improves glycemic control in obese subjects with type 2 diabetes

研究概览

地位

终止

条件

干预/治疗

详细说明

This is a randomized, double blinded, prospective study. Subjects will be evaluated and randomized to either the device or sham treatment group if they qualify for the study. A comparison of glycemic control between the two groups will be assessed as the primary outcome measurement as well as the safety profile of the device.

研究类型

介入性

注册 (实际的)

325

阶段

  • 不适用

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

  • 美国
    • Alabama
      • Birmingham、Alabama、美国、35294
        • University of Alabama at Birmingham
    • Arizona
      • Scottsdale、Arizona、美国、85259
        • Mayo Clinic Arizona
    • Arkansas
      • Little Rock、Arkansas、美国、72205
        • Little Rock Diagnostic Center (LRDC)
    • California
      • Los Angeles、California、美国、90048
        • Cedars-Sinai Medical Center
      • Stanford、California、美国、94305
        • Stanford University School of Medicine
    • Colorado
      • Aurora、Colorado、美国、80045
        • University of Colorado/ Anschutz Health & Wellness Center
    • Georgia
      • Atlanta、Georgia、美国、30303
        • Emory University
    • Illinois
      • Chicago、Illinois、美国、60208
        • Northwestern University
    • Kentucky
      • Louisville、Kentucky、美国、40218
        • Kentucky Research Group
    • Louisiana
      • New Orleans、Louisiana、美国、70112-2699
        • Tulane University Health Sciences Center
    • Maryland
      • Hyattsville、Maryland、美国、20782
        • Medstar Health Research Institute
    • Massachusetts
      • Boston、Massachusetts、美国、02114
        • Massachusetts General Hospital
      • Boston、Massachusetts、美国、02118
        • Boston Medical Center
    • Michigan
      • Ann Arbor、Michigan、美国、48109
        • University of Michigan
    • Minnesota
      • Rochester、Minnesota、美国、55905
        • Mayo Clinic Minnesota
    • Missouri
      • St Louis、Missouri、美国、63110
        • Washington University
    • Montana
      • Billings、Montana、美国、59101
        • Billings Clinic
    • New York
      • New York、New York、美国、10003
        • Beth Israel Medical Center
    • North Carolina
      • Chapel Hill、North Carolina、美国、27599
        • University of North Carolina
    • Ohio
      • Cleveland、Ohio、美国、44195
        • Cleveland Clinic
    • Oregon
      • Portland、Oregon、美国、97232
        • Legacy Research Institute
    • Tennessee
      • Knoxville、Tennessee、美国、37909
        • Endocrinology Consultants of East Tennessee & Gastrointestinal Associates
    • Texas
      • Dallas、Texas、美国、75230
        • Dallas Diabetes
      • Dallas、Texas、美国、75390-7170
        • UT Southwestern Medical Center
      • Houston、Texas、美国、77030
        • The Methodist Hospital Research Institute

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

17年 至 61年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Males/females aged ≥ 21 years and ≤ 65 years
  • Diagnosis of Type 2 Diabetes for ≤ 20 years
  • Obese individuals (BMI ≥ 30 kg/m2 and ≤ 55 kg/m2)
  • Stable doses (at least 3 months) of up to two anti-T2DM medications (MET, SU, DPP-4i or TZD)
  • Glycemic state: HbA1c at screening ≥ 7.5% and ≤ 10.0%.
  • Subjects willing to comply with study requirements
  • Subjects who have signed an informed consent form

Exclusion Criteria:

  • Diagnosis of type 1 diabetes mellitus or having any history of ketoacidosis
  • C-peptide < 1.0 ng/mL
  • Triglyceride level > 400 mg/dL
  • Vitamin D deficiency (<20 ng/mL)
  • Male subjects with serum Creatinine >1.5 mg/dl or female subjects with Creatinine >1.4 mg/dL
  • Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count less than 100,000/microliter, or known coagulopathy
  • Height < 5 feet (152.4 cm)
  • Current alcohol or drug addiction
  • Symptomatic kidney stones or gallstones within 6 months prior to randomization
  • Chronic pancreatitis or acute pancreatitis within 12 months of randomization
  • Diagnosis of osteoporosis or currently taking bisphosphonates or teriparatide
  • Diagnosis of an autoimmune connective tissue disorder (e.g., lupus erythematosus, scleroderma)
  • Active gastroesophageal reflux disease [GERD] uncontrolled with a Proton Pump Inhibitor (PPI)
  • Thyroid disease unless controlled with medication
  • Currently taking Non-Steroidal Anti-Inflammatory Drugs [NSAIDs] (e.g., aspirin, ibuprofen, etc.) within 10 days prior to randomization and/or there is a need or expected use of these agents during the trial 12 months post index procedure
  • Currently taking prescription antithrombotic therapy (e.g., anticoagulant or antiplatelet agent) within 10 days prior to randomization and/or there is a need or expected need to use during the trial 12 months post index procedure
  • Currently taking systemic corticosteroids, drugs known to affect GI motility, prescription/over-the-counter weight loss medications, or medications known to cause significant weight gain or weight loss within 30 days prior to randomization and/or there is a need or expected need to use these medications during the trial 12 months post index procedure
  • Medication for type 2 diabetes other than MET, SU, DPP-4i, and TZD (e.g., GLP1 or insulin) within 3 months of screening
  • Chronic use of narcotics, opiates, benzodiazepines, or other addictive tranquilizers
  • Allergy or hypersensitivity to ceftriaxone, cephalosporins, penicillin, or any equivalent antibiotics
  • Active Helicobacter pylori infection (Note: Subjects may be eligible after undergoing 2 weeks of antibiotic treatment without re-screening)
  • Previous GI surgery or abnormal GI anatomical finding that could preclude the ability to place the EndoBarrier device, liner or affect the function of the liner
  • Abnormal pathologies or conditions of the gastrointestinal tract, including current ulcers or Crohn's disease, history of atresias or untreated stenoses, current upper gastrointestinal bleeding conditions within 3 months of randomization
  • Any condition or major illness that places the subject at undue risk by participating in the study
  • Poor dentition not allowing complete chewing of food
  • Enrolled in another investigational study within 3 months of screening for this study (Enrollment in observational studies is permitted)
  • Residing in a location without ready access to study site medical resources
  • Documented weight loss of >10 pounds anytime during the 3 months preceding randomization
  • Positive stool guaiac at time of screening

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

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：Device (EndoBarrier)
Device for glycemic control
设备：EndoBarrier
Endoscopically-delivered and removable device comprised of an anchor that is placed in the duodenal bulb and a 60 cm long impermeable liner that passes distal from the anchor point
其他名称：
  • Duodenal-jejunal bypass liner (DJBL)
假比较器：Sham Procedure
sham procedure
程序：Sham Procedure
Endoscopic evaluation but no device placement

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Primary Efficacy Endpoint: Improvement in HbA1c
大体时间：Baseline and12 months
Mean Change in HbA1c from Baseline to 12 Months in the mITT population with Bayesian Imputation
Baseline and12 months
Primary Safety Endpoint: Early Device Removal Due to Device-Related SAE
大体时间：Baseline and 12 Months
Of the 161 subjects for whom data were available at 12 Months, 19 (11.8%) subjects experienced device-related SAEs that required an early device removal.
Baseline and 12 Months

次要结果测量

结果测量
大体时间
Assessment of Total Cholesterol Change at 12 Months Compared to Baseline
大体时间：Baseline and 12 Months
Baseline and 12 Months
Percentage of Subjects Who Achieve HbA1c Less Than or Equal to 7.0% at 12 Months
大体时间：Baseline and 12 Months
Baseline and 12 Months
LDL Change From Baseline
大体时间：Baseline and 12 Months
Baseline and 12 Months
Triglycerides Change From Baseline
大体时间：Baseline and 12 Months
Baseline and 12 Months
Fasting Glucose Change From Baseline
大体时间：Baseline and 12 Months
Baseline and 12 Months
Systolic BP Change From Baseline
大体时间：Baseline and 12 Months
Baseline and 12 Months
Diastolic BP Change From Baseline
大体时间：Baseline and 12 Months
Baseline and 12 Months
Percentage of Subjects Who Achieve % Total Body Weight Loss Greater Than or Equal to 5% at 12 Months
大体时间：Baseline and 12 Months
Baseline and 12 Months

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

GI Dynamics

调查人员

  • 学习椅：Lee M Kaplan, MD, PhD、Massachusetts General Hospital
  • 研究主任：Keith Gersin, MD、Carolinas Medical Center

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

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

2012年12月1日

初级完成 (实际的)

2016年2月1日

研究完成 (实际的)

2016年2月1日

研究注册日期

首次提交

2012年11月13日

首先提交符合 QC 标准的

2012年11月13日

首次发布 (估计)

2012年11月16日

研究记录更新

最后更新发布 (估计)

2017年2月1日

上次提交的符合 QC 标准的更新

2016年12月2日

最后验证

2016年12月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 09-1

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

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.

订阅