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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04052919
Acronym
GIIADMT1
Enrollment
19
Registered
2019-08-12
Start date
2018-02-01
Completion date
2019-08-01
Last updated
2019-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 1

Brief summary

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.

Interventions

OTHERCardiac 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.

Sponsors

Jessa Hospital
CollaboratorOTHER
Hasselt University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

* type 1 diabetes mellitus

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
transthoracic echocardiographyday 1cardiac 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,…)

Secondary

MeasureTime frameDescription
body compositionday 1Evaluation of body composition via bio-electrical impedance analyses. Via this analysis, the amount of fat-free body mass and fat body mass is calculated.
HbA1C levelday 1Evaluation of glycemic control
BMI (Body Mass Index)day 1Assessment of body composition using body mass index
glycemic controldaily (day 1- day 14)continuous monitoring/evaluation of glucose concentrations via glucose
weightday 1Anthropometric assessment
Physical activity questionairedaily (day 1 - day 14)Assessment of physical activity using a validated questionnaire (PAQ-A)
Heightday 1Anthropometric assessment

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026