CAnadian Normoglycemia Outcomes Evaluation Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 207
- 试验地点
- 2
- 主要终点
- Development of diabetes based on 1 positive OGTT or 2 fasting glucose levels
研究概览
简要总结
It is now well established that the 21st century will be characterized by a global epidemic of Type 2 diabetes. The principal aim of the CANOE study is to determine whether individuals with the pre-diabetes condition impaired glucose tolerance can be prevented from progressing to diabetes with a healthy living lifestyle intervention and an insulin sensitizing medication. Individuals who have impaired glucose tolerance (IGT) determined during an oral glucose tolerance test will be eligible to participate in this study. All participants will receive a lifestyle dietary and exercise intervention program. Half of the participants will be randomly assigned to an insulin sensitizing medication (rosiglitazone/metformin) which is commonly used to treat Type 2 diabetes. The primary outcome for this study is the development of diabetes. The study is expected to last a total of five years.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Residents of Ontario
- •Age 18-75
- •IGT on OGTT
排除标准
- •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
研究组 & 干预措施
A
Avandamet [ Rosuglitazone 2 and Metformin 500]
干预措施: Avandamet [Rosiglitazone 2mg/Metformin 500mg] BID (Drug)
结局指标
主要结局
Development of diabetes based on 1 positive OGTT or 2 fasting glucose levels
时间窗: Dec 2009
次要结局
- Lipids, CBC, CRP, homocysteine, adiponectin, insulin, proinsulin, and routine biochemistry will be done annually(Dec2009)