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

Diabetes Mellitus, Type 1 Clinical Trial

— GIIADMT1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04052919
• Other study ID #: GIIADMT1
• Status: Completed
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: August 1, 2019

Study information

• Verified date: August 2019
• Source: Hasselt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: August 1, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

Inclusion Criteria:

• type 1 diabetes mellitus

Exclusion Criteria:

• chronic diseases (except type 1 diabetes mellitus)

• disorders hindering exercise

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

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.

Locations

Country	Name	City	State
Belgium	Jessa Ziekenhuis	Hasselt

Sponsors (2)

Lead Sponsor	Collaborator
Hasselt University	Jessa Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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,…)	day 1
Secondary	glycemic control	continuous monitoring/evaluation of glucose concentrations via glucose	daily (day 1- day 14)
Secondary	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.	day 1
Secondary	HbA1C level	Evaluation of glycemic control	day 1
Secondary	BMI (Body Mass Index)	Assessment of body composition using body mass index	day 1
Secondary	Height	Anthropometric assessment	day 1
Secondary	weight	Anthropometric assessment	day 1
Secondary	Physical activity questionaire	Assessment of physical activity using a validated questionnaire (PAQ-A)	daily (day 1 - day 14)