An interventional study of Cardiac dysfunction in adolescents with type 1 diabetes in Diabetes Mellitus, Type 1, sponsored by Hasselt University. Completed at 1 site in Belgium. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2019-08-12.
Sponsored by Hasselt University · Not applicable, Interventional, and Screening
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.
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This study's enrollment of 19 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
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Exclusion Criteria:
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.
Other: Cardiac dysfunction in adolescents with type 1 diabetes
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.
transthoracic echocardiography
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,...)
Time frame: day 1
glycemic control
continuous monitoring/evaluation of glucose concentrations via glucose
Time frame: daily (day 1- day 14)
body composition
Evaluation of body composition via bio-electrical impedance analyses. Via this analysis, the amount of fat-free body mass and fat body mass is calculated.
Time frame: day 1
HbA1C level
Evaluation of glycemic control
Time frame: day 1
BMI (Body Mass Index)
Assessment of body composition using body mass index
Time frame: day 1
Height
Anthropometric assessment
Time frame: day 1
weight
Anthropometric assessment
Time frame: day 1
Physical activity questionaire
Assessment of physical activity using a validated questionnaire (PAQ-A)
Time frame: daily (day 1 - day 14)
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Hasselt University