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临床试验/NCT04052919
NCT04052919已完成不适用

Cardiac Dysfunction in Adolescents With Type 1 Diabetes: Contribution of Daily-life Glucoregulation and Impact on Cardiorespiratory Exercise Capacity

Hasselt University2 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2018年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
19
试验地点
2
主要终点
transthoracic echocardiography

研究概览

简要总结

During the course of type 1 diabetes mellitus (T1DM), several complications can occur. One of these is the development of diastolic and systolic dysfunction (even in the absence of ischemic, valvular or hypertensive heart disease). Such cardiac dysfunction and adverse remodeling is more common in adolescents with T1DM with a worse glycemic control (as evidenced by higher blood glycated hemoglobin HbA1c) concentrations. Even though an association has been observed between higher blood HbA1c concentrations and a worse cardiac function/structure in adolescents with T1DM, less is known about the specific characteristics of the glucoregulation (e.g. number and duration of hyperglycemic or hypoglycemic episodes, age of onset of T1DM,..) in relation to cardiac function/structure in this population. Therefore, the first aim of this study is to identify specific parameters related to glucoregulation which correlate with cardiac function and structure in adolescent with T1DM.

In T1DM, exercise training is generally recommended and included in the guidelines for the care of T1DM (due to beneficial effects on HbA1c levels, cardiovascular risk profile,..). However, as exercise training may increase the risk of hypoglycemic events, many patients may fear exercise, leading to inactivity or sedentarism. Logically, physical activity volumes are diverse in cohorts of this patient population, in which the long-term physically active T1DM patient will display an optimal or preserved cardiopulmonary exercise capacity, while a suboptimal cardiopulmonary exercise capacity will be noticed in mostly sedentary T1DM patients. The second aim of this study is to evaluate the association between cardiac function/structure and cardiopulmonary exercise capacity in adolescent T1DM patients (in the perspective of their physical activity behavior). This study thus may provide greater insights in the etiology and consequences of a disturbed cardiac function/structure in adolescents with T1DM.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

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

入选标准

  • type 1 diabetes mellitus

排除标准

  • chronic diseases (except type 1 diabetes mellitus)
  • disorders hindering exercise

研究组 & 干预措施

Cardiac dysfunction in adolescents with type 1 diabetes

Experimental

to identify specific parameters related to glucoregulation which correlate with cardiac function and structure in adolescent with T1DM.

In T1DM, exercise training to have beneficial effects on HbA1c levels, cardiovascular risk profile.

To evaluate the association between cardiac function/structure and cardiopulmonary exercise capacity in adolescent T1DM patients (in the perspective of their physical activity behavior). This study thus may provide greater insights in the etiology and consequences of a disturbed cardiac function/structure in adolescents with T1DM.

干预措施: Cardiac dysfunction in adolescents with type 1 diabetes (Other)

结局指标

主要结局

transthoracic echocardiography

时间窗: day 1

cardiac function/structure via transthoracic echocardiography: evaluation of diastolic and systolic function (mitral inflow pattern, ejection fraction, tissue doppler imaging, strain rate analyses,...) and cardiac structure (left ventricle mass, intraventricular wall mass,...)

次要结局

  • glycemic control(daily (day 1- day 14))
  • body composition(day 1)
  • HbA1C level(day 1)
  • BMI (Body Mass Index)(day 1)
  • Height(day 1)
  • weight(day 1)
  • Physical activity questionaire(daily (day 1 - day 14))

研究者

发起方
Hasselt University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dominique Hansen

prof. dr.

Hasselt University

研究点 (2)

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