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

November 28, 2024 updated by: Melanie Henderson, St. Justine's Hospital

Early Myocardial Morphologic and Functional Changes and Their Association With Diet and Physical Activity in Adolescents With Type 1 Diabetes

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; ii) measures of inflammation; and iii) markers of oxidative stress among adolescents with T1D and healthy controls, and determine group differences in these associations;
  3. explore, across both groups, the associations between these established and novel early markers of CVD with neighborhood features.
  4. Determine sex and gender differences in novel markers of CVD (cardiac structure/myocardial oxygenation, vascular studies including endothelial function and arterial stiffness) in youth with T1D and healthy controls;
  5. Determine, across both groups, sex and gender differences in associations between markers of CVD and lifestyle habits, specifically: i) moderate-to-vigorous physical activity (MVPA); ii) dietary intake (carbohydrates, sugar, saturated/trans-fat, fiber, food groups); iii) sedentary behavior; and iv) sleep;
  6. Measure changes in novel markers of CVD from adolescence to early adulthood among individuals with T1D and healthy controls;
  7. Assess whether lifestyle habits in adolescence are prospectively associated with established (dyslipidemia, hypertension) and novel (cardiac structure/myocardial oxygenation, endothelial function, arterial stiffness) markers of CVD in early adulthood, and if these associations differ according to T1D status, adiposity, sex and gender.

To achieve these objectives, we will compare 300 participants aged 14-18 years with T1D to 300 healthy controls. 100 participants from each group will be reassessed at the age of 22-26 yo. 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. Intestinal microbiota will be assessed. 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Suspended

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, H3T 1C5
        • CHU Sainte-Justine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

T1D group: Sainte-Justine Hospital's Diabetes Clinic patients

Control group: Community sample

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Diabetics
Girls and boys living with Type 1 Diabetes.
Control
Age and sex matched participants without any type of diabetes

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Cardiac structure (MRI)
Time Frame: Baseline measurement
Baseline measurement
Endothelial function (Flow-mediated dilation)
Time Frame: Baseline measurement
Baseline measurement
Vascular structure (Pulse-wave velocity)
Time Frame: Baseline measurement
Baseline measurement

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Dyslipidemia
Time Frame: Baseline measurement
Baseline measurement
Hypertension
Time Frame: Baseline measurement
Baseline measurement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
St. Justine's Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mélanie Henderson, MD, Ph.D, St. Justine's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 12, 2017

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 27, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 11, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2016-936
  • 366194 (Other Grant/Funding Number: Canadian Institutes of Health Research)
  • G-16-00012590 (Other Grant/Funding Number: Heart and Stroke Foundation of Canada)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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