Type 1 DiabetesCARDEANCT04304729
Determinants of Cardiovascular Disease Risk Factors Among Youth With Type 1 Diabetes
An observational study of Type 1 Diabetes and Cardiovascular Risk Factor, run by St. Justine's Hospital at 1 site in Canada.
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). Read more about this study
- Who is it for?
- Ages 14 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes, Cardiovascular Risk Factor
- How many people
- 600 participants
- Where
- 1 siteCanada
- Study dates
- 12 Jan 2017to 31 Dec 2030
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: T1D group: Sainte-Justine Hospital's Diabetes Clinic patients Control group: Community sample
Who may be able to join
- Diagnosis of T1D (for the T1D group) or no diagnosis of any type of diabetes (for the control group)
- 14 to 18 years old
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
- 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;
- 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;
- explore, across both groups, the associations between these established and novel early markers of CVD with neighborhood features.
- 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;
- 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;
- Measure changes in novel markers of CVD from adolescence to early adulthood among individuals with T1D and healthy controls;
- 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
- Keywords
- Type 1 Diabetes, Cardiovascular disease, Adolescents, Cardiac MRI, Diet, Physical activity, Sedentary behavior, Sleep
- Medical subject headings
- Diabetes Mellitus, Type 1, Cardiovascular Diseases, Motor Activity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Diabetics | Girls and boys living with Type 1 Diabetes. | |
| Control | Age and sex matched participants without any type of diabetes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac structure (MRI)
Measured: Baseline measurement
Endothelial function (Flow-mediated dilation)
Measured: Baseline measurement
Vascular structure (Pulse-wave velocity)
Measured: Baseline measurement
Secondary outcomes (2)
Dyslipidemia
Measured: Baseline measurement
Hypertension
Measured: Baseline measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2020
- Study start12 Jan 2017
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Why it stopped: Recruitment for phase 1 is completed, waiting for phase 2
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melanie Henderson, St. Justine's Hospital
- Investigators
- Mélanie Henderson, MD, Ph.D, Principal investigator, St. Justine's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04304729
- Sponsor's protocol ID
- 2016-936
- Other IDs
- 366194, G-16-00012590
- Acronym
- CARDEA
- Status last verified
- Nov 2024
- First submitted
- 27 Feb 2020
- Last updated
- 3 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34497076
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Myocardial Morphologic and Functional Changes and Their Association With Diet and Physical Activity in Adolescents With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT04304729
- Acronym / sponsor ID
- CARDEA / 2016-936
- Conditions
- Type 1 Diabetes, Cardiovascular Risk Factor
- Keywords
- Type 1 Diabetes, Cardiovascular disease, Adolescents, Cardiac MRI, Diet, Physical activity, Sedentary behavior, Sleep
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Recruitment for phase 1 is completed, waiting for phase 2
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Study start
- 12 Jan 2017 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 11 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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;
- 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;
- explore, across both groups, the associations between these established and novel early markers of CVD with neighborhood features.
- 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;
- 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;
- Measure changes in novel markers of CVD from adolescence to early adulthood among individuals with T1D and healthy controls;
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetics | – | –Girls and boys living with Type 1 Diabetes. |
| Control | – | –Age and sex matched participants without any type of diabetes |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- T1D group: Sainte-Justine Hospital's Diabetes Clinic patients Control group: Community sample
Key inclusion criteria (2 listed)
- Diagnosis of T1D (for the T1D group) or no diagnosis of any type of diabetes (for the control group)
- 14 to 18 years old
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cardiac structure (MRI)
Time frame: Baseline measurement
Endothelial function (Flow-mediated dilation)
Time frame: Baseline measurement
Vascular structure (Pulse-wave velocity)
Time frame: Baseline measurement
2 secondary outcomes
Dyslipidemia
Time frame: Baseline measurement
Hypertension
Time frame: Baseline measurement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
- Derived from this study: PubMed 34497076Henderson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mélanie Henderson, MD, Ph.D principal investigator
St. Justine's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes and Cardiovascular Risk Factor, run by St. Justine's Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac structure (MRI) (time frame: Baseline measurement). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04304729, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2024.