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临床试验/NCT01232608
NCT01232608已完成不适用

Exercise Training in Patients With Coronary Heart Disease and Type 2 Diabetes

Oslo University Hospital2 个研究点 分布在 1 个国家目标入组 137 人开始时间: 2010年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
137
试验地点
2
主要终点
Glucometabolic state

研究概览

简要总结

Diabetes mellitus (DM) is an important risk factor in the development of cardiovascular disease, and people with type 2 diabetes have a two- to four-fold increased risk for cardiovascular morbidity and mortality. Physical activity is a well established therapeutic modality for type 2 diabetes. In patients with coronary artery disease (CAD), several clinical trials have shown reduced mortality and reduced progression of atherosclerosis with lifestyle intervention including physical activity. But few studies have investigated the effect of physical training in patients suffering from both diseases.

The aim of this study is to investigate the effect of one year of organized physical exercise in patients with both coronary heart disease and type 2 diabetes on glucometabolic state and progression of atherosclerosis.

The project is a randomized, controlled, open study on physical exercise. 136 patients will be randomized at inclusion to a physical exercise group or a control group, the latter with "normal" follow-up and not discouraged form physical activity. The intervention period will be 12 months, and the physical training program will be developed and conducted in collaboration with Norwegian School of Sport Sciences. The inclusion of patients started summer 2010, the exercise program begins in September 2010 and the practical issues of the study is planned to end during spring 2012.

The main hypothesis is that physical exercise improves the glucometabolic state and reduces progression of atherosclerosis in patients with coronary heart disease and type 2 diabetes, and secondary that physical exercise induces favourable changes in cardiovascular risk factors, use of medication, and co-morbidity associated with diabetes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • coronary artery disease
  • type 2 diabetes

排除标准

  • serious diabetic retinopathy, nephropathy and/ or neuropathy
  • other serious diseases like cancer, stroke or MI last three months, unstable angina, decompensated heart failure, serious ventricular arrhythmia, aortic aneurism, serious valvular heart disease, chronic obstructive pulmonary disease GOLD classification IV, deep venous/ pulmonary embolism, ongoing infections, serious musculoskeletal disorders.
  • other serious limitations to physical exercise
  • pathological exercise stress test warranting further cardiovascular examination

结局指标

主要结局

Glucometabolic state

时间窗: 12 months

Glucometabolic state is defined as: HbA1c, fasting insulin, fasting c-peptid, fasting blood glucose

Atherosclerosis

时间窗: 12 months

Atherosclerosis will be assessed by measurements of: * Carotid intima-media thickness (IMT) * Biomarkers of inflammation, haemostasis and endothelial function

次要结局

  • Dyslipidemia(12 months)
  • Visceral obesity(12 months)

研究者

发起方
Oslo University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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