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

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Other: Cardiac dysfunction in adolescents with type 1 diabetes

• Registration Number: NCT04052919
• Lead Sponsor: Hasselt University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-19
• Study Start: 2018-02-01
• Status Verified: 2019-08
• Primary Completion: 2019-08-01
• Study Completion: 2019-08-01
• Study First Submitted QC: 2019-08-09
• Last Update Submitted: 2019-08-09
• Study First Posted: 2019-08-12
• Last Update Posted: 2019-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

• type 1 diabetes mellitus

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cardiac dysfunction in adolescents with type 1 diabetes	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.

Primary Outcome Measures

Name	Time	Method
transthoracic echocardiography	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,...)

Secondary Outcome Measures

Name	Time	Method
glycemic control	daily (day 1- day 14)	continuous monitoring/evaluation of glucose concentrations via glucose
body composition	day 1	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.
HbA1C level	day 1	Evaluation of glycemic control
BMI (Body Mass Index)	day 1	Assessment of body composition using body mass index
Height	day 1	Anthropometric assessment
weight	day 1	Anthropometric assessment
Physical activity questionaire	daily (day 1 - day 14)	Assessment of physical activity using a validated questionnaire (PAQ-A)

Trial Locations

Locations (1)

Jessa Ziekenhuis; 🇧🇪 Hasselt, Belgium