NCT04304729: CARDEA

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

Suspended Last updated 3 December 2024

What this trial tests

trial in Type 1 Diabetes in 600 participants. Suspended.

Timeline

12 January 2017

Primary endpoint
31 December 2030

31 December 2030

Quick facts

Lead sponsor	St. Justine's Hospital
Status	Suspended
Study type	OBSERVATIONAL
Enrollment	600
Start date	12 January 2017
Primary completion	31 December 2030
Estimated completion	31 December 2030
Sites	1 location across Canada

Conditions studied

• Type 1 Diabetes — all drugs for Type 1 Diabetes →
• Cardiovascular Risk Factor — all drugs for Cardiovascular Risk Factor →

Sponsor

St. Justine's Hospital

Who can join

Adults 14 to 18, any sex, with Type 1 Diabetes or Cardiovascular Risk Factor. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. CARDEA study protocol: investigating early markers of cardiovascular disease and their association with lifestyle habits, inflammation and oxidative stress in adolescence using a cross-sectional comparison of adolescents with type 1 diabetes and healthy controls.
   Henderson M, Friedrich M, Van Hulst A, Pelletier C, et al · · 2021 · cited 6× · PMID 34497076 · DOI 10.1136/bmjopen-2020-046585