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

NCT04052919 | Completed

• 1 other identifier: GIIADMT1
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• glycemic control

  daily (day 1- day 14)

• body composition

  day 1

• HbA1C level

  day 1

• BMI (Body Mass Index)

  day 1

• Height

  day 1

Study Arms (1)

Cardiac dysfunction in adolescents with type 1 diabetes

EXPERIMENTAL

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.

Other: Cardiac dysfunction in adolescents with type 1 diabetes

Interventions

Cardiac dysfunction in adolescents with type 1 diabetes OTHER

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.

Cardiac dysfunction in adolescents with type 1 diabetes

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• type 1 diabetes mellitus

You may not qualify if:

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

Sponsors & Collaborators

• Hasselt University: lead
• Jessa Hospital: collaborator

Study Sites (1)

Jessa Ziekenhuis

Hasselt, 3500, Belgium

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Dominique Hansen, prof. dr.

  Hasselt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof. dr.

Study Record Dates

• First Submitted: December 19, 2017
• First Posted: August 12, 2019
• Study Start: February 1, 2018
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: August 12, 2019

Record last verified: 2019-08

Locations

BE (1)