A Lifestyle and Combination Medication Therapy Diabetes Prevention Study
CAnadian Normoglycemia Outcomes Evaluation Study
研究概览
详细说明
The CANOE Study CAnadian Normoglycemia Outcomes Evaluation Study
It is now well accepted that the 21st Century will be characterized by a global epidemic of Type 2 diabetes mellitus [Type 2DM]. To deal with this major health crisis, several strategies have been proposed. These include efforts that focus on the primary prevention of diabetes, attempts at implementing effective management of diabetes once it develops, and the institution of appropriate proven therapies for established diabetic complications. The CANOE study focuses on a primary prevention strategy. The study is designed to evaluate the effect of pharmacological therapy combined with a healthy living lifestyle intervention on Canadian individuals who are at high risk for this metabolic condition because they have IGT.
OBJECTIVES
- To determine if treatment with Avandamet, in addition to a healthy living lifestyle program, will prevent the development of Type 2 diabetes in Canadians at high risk for this metabolic disorder;
- To determine if treatment with Avandamet, in addition to a healthy living lifestyle program will improve cardiovascular risk factors associated with IGT.
STUDY DESIGN
CANOE is a moderately sized, randomized, double-blind controlled trial to determine if Avandamet will decrease the development of diabetes in individuals at high risk for this condition. A total of 200 patients will be followed for an average follow up of 4 years (range 3 - 5 years). Active treatment with Avandamet (Metformin 500 mg / Rosiglitazone 2 mg) administered as one capsule twice daily will be compared to matched placebo.
All study participants will receive a lifestyle intervention program based on the latest national evidence-based guidelines recommended by the Canadian Diabetes Association (Can J Diabetes, Vol 27 Suppl 2, 2003).
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
-
-
Ontario
-
London、Ontario、加拿大、N6G 4X8
- UWO Research Park
-
Toronto、Ontario、加拿大、M5G 1X5
- Mount Sinai Hospital
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Residents of Ontario
- Age 18-75
- IGT on OGTT
Exclusion Criteria:
- Current use of Metformin or Rosiglitazone
- Prior use of medication to treat diabetes except gestational diabetes
- Use of drugs known to exacerbate glucose tolerance
- History of diabetes except gestational diabetes
- Liver function studies greater the 2.5x normal
- Creatinine clearance less than 60 ml/min
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 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 |
---|---|
有源比较器:A
Avandamet [ Rosuglitazone 2 and Metformin 500]
|
[Rosiglitazone 2mg/ Metformin 500mg] twice daily
其他名称:
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Development of diabetes based on 1 positive OGTT or 2 fasting glucose levels
大体时间:Dec 2009
|
Dec 2009
|
次要结果测量
结果测量 |
大体时间 |
---|---|
Lipids, CBC, CRP, homocysteine, adiponectin, insulin, proinsulin, and routine biochemistry will be done annually
大体时间:Dec2009
|
Dec2009
|
合作者和调查者
调查人员
- 首席研究员:Bernard Zinman, MD、Mount Sinai Hospital
- 首席研究员:Stewart Harris, MD、Western University, Canada
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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