Peripheral Vascular REactivity and Muscular Oxygenation in Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 125
- 试验地点
- 2
- 主要终点
- Near-infrared spectroscopy during exercise
研究概览
简要总结
Oxygen is required for an optimal muscle function. In patients with diabetes mellitus, hyperglycemia can cause vascular complications. The endothelium (inter layer of the blood vessels) can be damaged leading to a reduced oxygen flow towards the muscle cells. Besides, it is possible that mitochondrial dysfunction is occuring leading to reduced extraction of oxygen.
Both conditions will lead to a reduced flow of oxygen towards the muscle and this can have impact on the production of energy necessary for optimal functioning.
In this study, the investigators will examine the functionality of the blood vessels (1) and the uptake of oxygen into the muscles (2) in patients with diabetes mellitus type 1 and type 2 (with and without vascular complications) compared to healthy persons.
详细描述
The investigators plan to recruit in total 125 participants who will be divided into 3 main groups: (I) diabetes mellitus type 1 (with (a) or without (b) vascular complications), (II) diabetes mellitus type 2 (with (a) or without (b) vascular complications), and (III) healthy persons. Diabetes mellitus will be defined by the guidelines of the American Diabetes Association (ADA).
The examinations for this study consist of a blood pressure assessment, Flow Mediated Dilatation (FMD)-measurement, and a handgrip exercise test. The protocol will take approximately 2 hours.
The investigator who performs the FMD-test followed a course and passed thorough evaluation.
The blood pressure assessment will be continuously for 20 minutes to avoid large bias.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
盲法说明
There is no masking because the participant knows his diagnosis. Besides, the investigator checks the blood sugar at different times during the examinations, so also the investigator is not blinded. In this study, blinding would have no additional value.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •men and women
- •age 18-85 years old
- •diabetes mellitus type 1 or type 2 (with or without vascular complications, healthy participants
排除标准
- •other types of diabetes mellitus than type 1 or type 2
- •alcohol abuse
- •active cancer
- •pregnancy
结局指标
主要结局
Near-infrared spectroscopy during exercise
时间窗: 30 minutes, at study-day (participants have to come only once, no follow-up, no re-testing)
analysis of changes in oxygenated blood during exercise
Flow Mediated Dilatation (FMD)-test
时间窗: 20 minutes, at study-day (participants have to come only once, no follow-up, no re-testing)
flow mediated dilatation test
exercise test wilt hand held dynamometer
时间窗: 30 minutes, at study-day (participants have to come only once, no follow-up, no re-testing)
analysis of strength and exercise capacity
次要结局
- Blood pressure analysis(20 minutes, at study-day (participants have to come only once, no follow-up, no re-testing))