Cardiovascular Autonomic Neuropathy in Patients With Type 1 Diabetes Mellitus.
研究概览
详细说明
Cardiovascular autonomic neuropathy is a common (sub)clinical symptom in persons with type 1 diabetes mellitus. Subjects in this non-commercial, monocentric, interventional study undergo autonomic function tests, a maximal ergospirometry and three questionnaires about the quality of life (EQ-5D-3L), the capacity to do physical activities (IPAQ) and the experience of possible symptoms of autonomic dysfunction in daily life (SCOPA-AUT). In this way the influence of type 1 diabetes mellitus on the quality of life, the exercise capacity and the autonomic function can be studied.
The primary aim of this study investigates the potential correlations between the severity of diabetic cardiovascular autonomic neuropathy (DCAN) and both the quality of life and the exercise capacity. As a secondary aim, the influences of gender, age, number of years since diagnosis of type 1 diabetes mellitus, VO2 max predicted, maximal heart rate during exercise, minimal heart rate in rest, maximal RER (Respiratory exchange ratio) and relevant interaction terms are studied.
In total 52 test subjects with type 1 diabetes mellitus and 27 matched control subjects are selected to participate in this study.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Hasselt、比利时、3500
- Jessa Ziekenhuis
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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:
- Type 1 diabetes mellitus (only for the group of subjects with diabetes mellitus)
- At least two years with diagnosis of type 1 diabetes mellitus
- Subject is in a stable condition
- No hospitalization for any reason in the past three months
- 18 years or older
- Being capable of doing physical activities
- Understand the study design and the informed consent
- Sign the informed consent
- No simultaneously participation to another study
- Being capable of moving to the study center
Exclusion Criteria:
- Uncontrolled hypertension, atrial fibrillation and other cardiovascular conditions
- Severe lung disease
- Muscle deficiency
Medication with influence on the autonomic nervous system:
- Beta blockers
- Alfa blockers
- Antidepressants
- Non-catecholamines
- (anti) cholinergic medication
学习计划
研究是如何设计的？
设计细节
- 主要用途：放映
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：subjects with Type 1 Diabetes mellitus
Type 1 diabetes patients without cardiovascular disease undergo autonomic function testing
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autonomic function testing, ergospirometry, three questionnaires Other Names:
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安慰剂比较：Healthy controls
healthy people without known disease undergo autonomic function testing
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autonomic function testing, ergospirometry, three questionnaires Other Names:
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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VO2 max
大体时间：day 1
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peak oxygen consumption
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day 1
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合作者和调查者
合作者
调查人员
- 首席研究员：Paul Dendale, prof. dr.、Jessa Hospital
- 学习椅：Renee De Busser, student、Hasselt University
- 学习椅：Anika Nys, student、Hasselt University
研究记录日期
研究主要日期
学习开始 (实际的)
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 (实际的)
研究记录更新
最后更新发布 (实际的)
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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