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CARDEA: Determinants of Cardiovascular Disease Risk Factors Among Youth With Type 1 Diabetes

Sponsor
St. Justine's Hospital (Other)
Overall Status
Suspended
CT.gov ID
NCT04304729
Collaborator
(none)
200
Enrollment
1
Location
155.6
Anticipated Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Type 1 diabetes mellitus (T1D) is the most common form of diabetes among children and youth, and it is increasing around the world, particularly among children under 5 years. This is worrisome given the chronic nature of the disease and its strong association with an increased risk of cardiovascular disease (CVD). Evidence suggests that markers of CVD are already present in children with T1D, making prevention a clinical and public health priority in this high-risk population. Despite this, a good understanding of what factors predispose children with T1D to CVD is still lacking.

Our study aims to better understand in this population what individual, familial and environmental characteristics increase the risk for heart disease, how to best measure it early on and what are the potential mechanisms underlying the heightened risk for heart disease in youth with T1D. Specifically, we aim to:

  1. compare established risk factors (dyslipidemia, hypertension) with novel early markers for CVD (cardiac phenotype, arterial stiffness, endothelial function) in adolescents with T1D and healthy controls;

  2. examine the associations between these novel early markers with: i) lifestyle habits;

  1. measures of inflammation; and iii) markers of oxidative stress among adolescents with T1D and healthy controls, and determine group differences in these associations;
  1. explore, across both groups, the associations between these established and novel early markers of CVD with neighborhood features.

To achieve these objectives, we will compare 100 participants aged 14-18 years with T1D to 100 healthy controls. Lifestyle habits include assessments of physical activity, sleep, sedentary behavior, fitness and dietary intake. Blood pressure and lipid profiles will be measured. Cardiac structure/function will be evaluated by non-contrast cardiac magnetic resonance imaging (CMR). Aortic distensibility will be determined by pulse wave velocity. Endothelial function will be determined by flow-mediated dilation. Inflammatory markers and endogenous antioxidants will be measured in blood. Neighbourhood features include built and social environment indicators and air quality.

Our study provides an exceptional opportunity to increase our knowledge on what factors predispose children with T1D to cardiovascular disease. Understanding the interplay between T1D, lifestyle habits and metabolic markers and CVD is critical to developing effective prevention strategies for these vulnerable children.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Early Myocardial Morphologic and Functional Changes and Their Association With Diet and Physical Activity in Adolescents With Type 1 Diabetes
    Actual Study Start Date :
    Jan 12, 2017
    Anticipated Primary Completion Date :
    Dec 31, 2029
    Anticipated Study Completion Date :
    Dec 31, 2029

    Arms and Interventions

    Arm Intervention/Treatment
    Diabetics

    Girls and boys aged 14-18 years old, living with Type 1 Diabetes.
    Control

    Age and sex matched adolescents without any type of diabetes

    Outcome Measures

    Primary Outcome Measures

    1. Cardiac structure (MRI) [Baseline measurement]

    2. Endothelial function (Flow-mediated dilation) [Baseline measurement]

    3. Vascular structure (Pulse-wave velocity) [Baseline measurement]

    Secondary Outcome Measures

    1. Dyslipidemia [Baseline measurement]

    2. Hypertension [Baseline measurement]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    14 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Diagnosis of T1D (for the T1D group) or no diagnosis of any type of diabetes (for the control group)

    • 14 to 18 years old

    Exclusion Criteria:

    • Youth with another type of diabetes such as T2D

    • Conditions that could limit their ability to participate in the study

    • Known pathology that would influence their risk for CVD

    • Siblings of a participant already enrolled in the study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU Sainte-Justine Montréal Quebec Canada H3T 1C5

    Sponsors and Collaborators

    • St. Justine's Hospital

    Investigators

    • Principal Investigator: Mélanie Henderson, MD, Ph.D, St. Justine's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Melanie Henderson, Associate professor, Pediatrics, St. Justine's Hospital
    ClinicalTrials.gov Identifier:
    NCT04304729
    Other Study ID Numbers:
    • 2016-936
    • 366194
    • G-16-00012590
    First Posted:
    Mar 11, 2020
    Last Update Posted:
    Mar 10, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Melanie Henderson, Associate professor, Pediatrics, St. Justine's Hospital
    Type 1 Diabetes
    Cardiovascular disease
    Adolescents
    Cardiac MRI
    Diet
    Physical activity
    Sedentary behavior
    Sleep
    Additional relevant MeSH terms:
    Cardiovascular Diseases
    Diabetes Mellitus
    Diabetes Mellitus, Type 1

    Study Results

    No Results Posted as of Mar 10, 2022