Clinical trial NCT04052919: Cardiac Dysfunction in Adolescents With Type 1 Diabetes: Contribution of Daily-life Glucoregulation and Impact on Cardiorespiratory Exercise Capacity
Official title: Cardiac Dysfunction in Adolescents With Type 1 Diabetes: Contribution of Daily-life Glucoregulation and Impact on Cardiorespiratory Exercise Capacity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: Jessa Hospital
First posted: 2019-08-12
Enrollment: 19
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.


Eligibility criteria: Inclusion Criteria:

* type 1 diabetes mellitus

Exclusion Criteria:

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

Primary outcomes:
measure: transthoracic echocardiography
timeFrame: day 1
Secondary outcomes:
measure: glycemic control
timeFrame: daily (day 1- day 14)
measure: body composition
timeFrame: day 1
measure: HbA1C level
timeFrame: day 1
measure: BMI (Body Mass Index)
timeFrame: day 1
measure: Height
timeFrame: day 1
measure: weight
timeFrame: day 1
measure: Physical activity questionaire
timeFrame: daily (day 1 - day 14)
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis
Study officials:
affiliation: Hasselt University
name: Dominique Hansen, prof. dr.
role: PRINCIPAL_INVESTIGATOR
References: