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Clinical Trials/NCT04052919
NCT04052919
Completed
Not Applicable

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

Hasselt University1 site in 1 country19 target enrollmentFebruary 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes Mellitus, Type 1
Sponsor
Hasselt University
Enrollment
19
Locations
1
Primary Endpoint
transthoracic echocardiography
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2018
End Date
August 1, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Hasselt University
Responsible Party
Principal Investigator
Principal Investigator

Dominique Hansen

prof. dr.

Hasselt University

Eligibility Criteria

Inclusion Criteria

  • type 1 diabetes mellitus

Exclusion Criteria

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

Outcomes

Primary Outcomes

transthoracic echocardiography

Time Frame: 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 Outcomes

  • 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))

Study Sites (1)

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