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

NCT04304729 | Suspended

• 3 other identifiers: 2016-936366194G-16-00012590
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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. 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. 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. 3.explore, across both groups, the associations between these established and novel early markers of CVD with neighborhood features.
4. 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. 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. 6.Measure changes in novel markers of CVD from adolescence to early adulthood among individuals with T1D and healthy controls;
7. 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.

Conditions

Type 1 Diabetes; Cardiovascular Risk Factor

Keywords

Type 1 Diabetes; Cardiovascular disease; Adolescents; Cardiac MRI; Diet; Physical activity; Sedentary behavior; Sleep

Outcome Measures

Primary Outcomes (3)

• Cardiac structure (MRI)

  Baseline measurement

• Endothelial function (Flow-mediated dilation)

  Baseline measurement

• Vascular structure (Pulse-wave velocity)

  Baseline measurement

Secondary Outcomes (2)

• Dyslipidemia

  Baseline measurement

• Hypertension

  Baseline measurement

Study Arms (2)

Diabetics

Girls and boys living with Type 1 Diabetes.

Control

Age and sex matched participants without any type of diabetes

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Diagnosis of T1D (for the T1D group) or no diagnosis of any type of diabetes (for the control group)
• to 18 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Justine's Hospital: lead

Study Sites (1)

CHU Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

Location

Related Publications (1)

• Henderson M, Friedrich M, Van Hulst A, Pelletier C, Barnett TA, Benedetti A, Bigras JL, Drapeau V, Lavoie JC, Levy E, Mathieu ME, Nuyt AM. 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. BMJ Open. 2021 Sep 8;11(9):e046585. doi: 10.1136/bmjopen-2020-046585.

  PMID: 34497076 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma, serum, whole blood, urine, feces

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Cardiovascular Diseases; Motor Activity; Sedentary Behavior

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Study Officials

• Mélanie Henderson, MD, Ph.D

  St. Justine's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, Pediatrics

Study Record Dates

• First Submitted: February 27, 2020
• First Posted: March 11, 2020
• Study Start: January 12, 2017
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: December 3, 2024

Record last verified: 2024-11

Locations

CA (1)