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临床试验/NCT00212303
NCT00212303已完成4 期

Exercise Training in Type 2 Diabetes and Hypertension

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)2 个研究点 分布在 1 个国家目标入组 115 人开始时间: 2004年5月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
115
试验地点
2
主要终点
Blood pressure at 6 months

研究概览

简要总结

The coexistence of diabetes and hypertension is damaging to cardiac and peripheral vascular structure and function. Although several health organizations endorse exercise training as a treatment for type 2 diabetes, most studies of exercise and diabetes have focused on controlling blood sugar but not on cardiovascular health. The aim of this study is to determine if exercise training reduces blood pressure and improves cardiovascular health in persons who have both type 2 diabetes and hypertension. An equal number of men and women will be enrolled, and another aim of the study is to examine gender differences in response to exercise training.

详细描述

Type 2 diabetes is associated with damage, dysfunction, and failure of various organs. The coexistence of diabetes and hypertension is particularly damaging to cardiac and peripheral vascular structure and function. These diseases, either alone or combined, result in increased left ventricular mass and wall thickness, left ventricular diastolic dysfunction, impaired endothelial vasodilator function, and increased vascular stiffness. Although several health organizations endorse exercise training as a therapeutic modality for type 2 diabetes, most studies of exercise and diabetes have focused on glycemic control but not on cardiovascular health. Although exercise lowers blood pressure in persons without diabetes, there are profound gaps in knowledge about the effects of exercise training on blood pressure and cardiovascular health in persons with type 2 diabetes. The primary specific aim of this study is to determine if exercise training reduces blood pressure in persons who have both type 2 diabetes and high normal blood pressure or mild hypertension prehypertension or Stage 1 (mild) hypertension. Subjects will be randomized to 6-months of exercise training, consistent with established guidelines for diabetes and for hypertension, or to a usual care control group. The second specific aim is to identify the effects of exercise training on parameters of cardiac and peripheral vascular structure and function related to cardiovascular disease in diabetes and hypertension. We will assess left ventricular mass, left ventricular diastolic function, endothelial vasodilator function, and vascular stiffness using high-resolution ultrasound, Doppler echocardiography, and magnetic resonance imaging. We will also examine interleukin-6 and high-resolution C-reactive protein as novel risk factors for cardiovascular disease and diabetes to determine the effects of exercise training on the inflammatory process. Because exercise training improves fitness and may improve body composition and regional fat distribution, the associations of change in these parameters with change in blood pressure and cardiac and peripheral vascular structure and function will be analyzed. An equal number of men and women will be enrolled, and a third specific aim of the study is to examine gender differences in response to exercise training. This study will expand the scientific knowledge that defines exercise guidelines and will provide new insight into the mechanisms by which exercise reduces blood pressure and improves cardiovascular health in persons with type 2 diabetes and hypertension.

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
40 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ages 40-65 years type 2 diabetes BP between SBP 120-159 or DBP 80-99 mm Hg sedentary

排除标准

  • cardiovascular disease abnormal exercise stress test smoking insulin use major illnesses that would preclude exercise training pregnancy in women engaged in regular exercise or weight loss diet program substance abuse morbid obesity BMI > 42

结局指标

主要结局

Blood pressure at 6 months

时间窗: 6 months

次要结局

  • Cardiac and peripheral structure and function at 6 months(6 months)
  • Fitness and body composition at 6 months(6 months)
  • Cardiac and diabetes risk factors at 6 months(6 months)
  • Systemic inflammation at 6 months(6 months)

研究者

申办方类型
Nih
责任方
Principal Investigator
主要研究者

Kerry Stewart

Professor of Medicine

Johns Hopkins University

研究点 (2)

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