Determinants of Cardiovascular Disease Risk Factors Among Youth With Type 1 Diabetes
NCT04304729 · Status: SUSPENDED · Type: OBSERVATIONAL · Enrollment: 600
Last updated 2024-12-03
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; 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.
Conditions
- Type 1 Diabetes
- Cardiovascular Risk Factor
Sponsors & Collaborators
-
St. Justine's Hospital
lead OTHER
Principal Investigators
-
Mélanie Henderson, MD, Ph.D · St. Justine's Hospital
Eligibility
- Min Age
- 14 Years
- Max Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2017-01-12
- Primary Completion
- 2030-12-31
- Completion
- 2030-12-31
Countries
- Canada
Study Locations
More Related Trials
-
Vascular Inflammation in Adolescents With Type 1 Diabetes
NCT00933101 ·Status: COMPLETED
-
Vascular Function in Adolescent, Diabetic Children
NCT00348179 ·Status: COMPLETED ·Phase: NA
-
Early Detection of Long-term Diabetic Complications in Children and Adolescents With Type 1 Diabetes
NCT05159856 ·Status: RECRUITING
-
Cardiovascular Disease Risk in Children With Type 1 Diabetes Mellitus
NCT06356051 ·Status: COMPLETED
-
Pathogenesis of the Cardiometabolic Risk in Youth With Type 1 Diabetes
NCT04101045 ·Status: TERMINATED ·Phase: NA
-
Isometric Handgrip Exercise -MRI in Children and Adolescents
NCT03506711 ·Status: COMPLETED ·Phase: NA
-
Activation Innate Immune System in Type 1 Diabetes
NCT03441919 ·Status: COMPLETED
-
Mortality and Cardiovascular Diseases in Adult-onset Type 1 Diabetes
NCT06563401 ·Status: RECRUITING
-
The Impact of Fitness on Vascular Dysfunction in Adolescents With Type 1 Diabetes
NCT01337947 ·Status: COMPLETED
-
French National Cohort of People With Type 1 Diabetes
NCT04657783 ·Status: RECRUITING
-
Metabolic Changes Induced by a Very Low Carbohydrate Diet in Youth With Type 1 Diabetes
NCT04955691 ·Status: COMPLETED ·Phase: NA
-
ECG Changes in Children and Adolescents With Type 1 Diabetes
NCT03260998 ·Status: UNKNOWN
-
Low Grade Inflammation in Type 1 Diabetes Children
NCT01099956 ·Status: COMPLETED
-
The Effect of Type 1 Diabetes on Pan-Arterial Vascular Function and Insulin Sensitivity in Humans
NCT02490124 ·Status: COMPLETED
-
Exercise in Adolescents With Insulin Resistance
NCT04154865 ·Status: TERMINATED ·Phase: NA
-
T1DM Clinical Onset and Progression in Paediatric Population
NCT03547440 ·Status: COMPLETED
-
Evaluation of Neurodevelopmental Trajectories in Children According to the Glycemic Profile Associated With Different Early Treatment Modalities in Children With Type 1 Diabetes (T1DM)
NCT06461065 ·Status: RECRUITING ·Phase: NA
-
Diabetes Type 1 and Fitness.
NCT04968171 ·Status: RECRUITING
-
Risk Factors for Atherogenesis in Type 1 Diabetes
NCT00035750 ·Status: COMPLETED
-
Electrocardiographic Modifications and Spontaneous Hypoglycemic Episodes in Type 1 Diabetes
NCT03682250 ·Status: TERMINATED
-
Cardiovascular Effects of Exercise-related Hypoglycaemia in Patients With Type 1 Diabetes (Hypo Heart Exercise)
NCT04650646 ·Status: COMPLETED ·Phase: NA
-
Wisconsin Epidemiological Study of Cardiovascular Disease in Type 1 Diabetes
NCT00005539 ·Status: COMPLETED
-
The Current Health Status of Patients Living With Type 1 Diabetes From the LMC Diabetes Patient Registry
NCT04162067 ·Status: COMPLETED
-
cArdiopulmonary exerCise Test Assessing Multiple bIOmarkers iN Type 1 Diabetes
NCT05097339 ·Status: COMPLETED
-
Phase Angle and TyG Index as Markers of Glycaemic Control, Adiposity and Cardiovascular Risk in T1D Adolescents
NCT07021326 ·Status: COMPLETED