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

Type 1 Diabetes Clinical Trial

— CARDEA  

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04304729
• Other study ID #: 2016-936
• Secondary ID: 366194G-16-00012
• Status: Suspended
• Start date: January 12, 2017
• Est. completion date: December 31, 2029

Study information

• Verified date: May 2023
• Source: St. Justine's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 200
• Est. completion date: December 31, 2029
• Est. primary completion date: December 31, 2029
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Cardiovascular Risk Factor
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Locations

Country	Name	City	State
Canada	CHU Sainte-Justine	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
St. Justine's Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac structure (MRI)		Baseline measurement
Primary	Endothelial function (Flow-mediated dilation)		Baseline measurement
Primary	Vascular structure (Pulse-wave velocity)		Baseline measurement
Secondary	Dyslipidemia		Baseline measurement
Secondary	Hypertension		Baseline measurement