Cardiac Dysfunction in Adolescents With Type 1 Diabetes: Contribution of Daily-life Glucoregulation and Impact on Cardiorespiratory Exercise Capacity (GIIADMT1)
Primary Purpose
Diabetes Mellitus, Type 1
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Cardiac dysfunction in adolescents with type 1 diabetes
Sponsored by
About this trial
This is an interventional screening trial for Diabetes Mellitus, Type 1
Eligibility Criteria
Inclusion Criteria:
- type 1 diabetes mellitus
Exclusion Criteria:
- chronic diseases (except type 1 diabetes mellitus)
- disorders hindering exercise
Sites / Locations
- Jessa Ziekenhuis
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cardiac dysfunction in adolescents with type 1 diabetes
Arm Description
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.
Outcomes
Primary Outcome Measures
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,…)
Secondary Outcome Measures
glycemic control
continuous monitoring/evaluation of glucose concentrations via glucose
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.
HbA1C level
Evaluation of glycemic control
BMI (Body Mass Index)
Assessment of body composition using body mass index
Height
Anthropometric assessment
weight
Anthropometric assessment
Physical activity questionaire
Assessment of physical activity using a validated questionnaire (PAQ-A)
Full Information
NCT ID
NCT04052919
First Posted
December 19, 2017
Last Updated
August 9, 2019
Sponsor
Hasselt University
Collaborators
Jessa Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04052919
Brief Title
Cardiac Dysfunction in Adolescents With Type 1 Diabetes: Contribution of Daily-life Glucoregulation and Impact on Cardiorespiratory Exercise Capacity
Acronym
GIIADMT1
Official Title
Cardiac Dysfunction in Adolescents With Type 1 Diabetes: Contribution of Daily-life Glucoregulation and Impact on Cardiorespiratory Exercise Capacity
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
August 1, 2019 (Actual)
Study Completion Date
August 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasselt University
Collaborators
Jessa Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cardiac dysfunction in adolescents with type 1 diabetes
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Cardiac dysfunction in adolescents with type 1 diabetes
Intervention Description
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 Measure Information:
Title
transthoracic echocardiography
Description
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,…)
Time Frame
day 1
Secondary Outcome Measure Information:
Title
glycemic control
Description
continuous monitoring/evaluation of glucose concentrations via glucose
Time Frame
daily (day 1- day 14)
Title
body composition
Description
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.
Time Frame
day 1
Title
HbA1C level
Description
Evaluation of glycemic control
Time Frame
day 1
Title
BMI (Body Mass Index)
Description
Assessment of body composition using body mass index
Time Frame
day 1
Title
Height
Description
Anthropometric assessment
Time Frame
day 1
Title
weight
Description
Anthropometric assessment
Time Frame
day 1
Title
Physical activity questionaire
Description
Assessment of physical activity using a validated questionnaire (PAQ-A)
Time Frame
daily (day 1 - day 14)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
type 1 diabetes mellitus
Exclusion Criteria:
chronic diseases (except type 1 diabetes mellitus)
disorders hindering exercise
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominique Hansen, prof. dr.
Organizational Affiliation
Hasselt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jessa Ziekenhuis
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Cardiac Dysfunction in Adolescents With Type 1 Diabetes: Contribution of Daily-life Glucoregulation and Impact on Cardiorespiratory Exercise Capacity
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