Vascular Complications in Children From T1D Diagnosis

NCT ID: NCT05790785

Last Updated: 2025-05-02

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-03-25
• Study Completion Date: 2027-09-30

Brief Summary

Cardiovascular disease is a complication of type 1 diabetes (T1D), a life-long disease, usually diagnosed in childhood. The goal of this project is to determine the timing and factors leading to vascular damage in children from T1D diagnosis.

Detailed Description

This is a prospective longitudinal cohort study investigating vascular health in children over the first 2 years of type1 diabetes (T1D) diagnosis living in Metro Vancouver, Canada.

Cardiovascular disease is a major complication of T1D traditionally considered a longterm complication that manifests in adulthood. However, several studies have reported evidence of cardiovascular disease in children who have had T1D for more than 1 year but it is unclear how and when the cardiovascular damage begins. There is also minimal data on cardiovascular complications in children with type 1 diabetes living in Canada.

The goal of this project is to determine the timing and factors leading to vascular damage in children from T1D diagnosis.

We will follow children (aged 8-18 years) from T1D diagnosis over the first 2 years. The primary objective of the study is to assess changes in arterial stiffness (pulse wave velocity; augmentation index), 24-h ambulatory blood pressure (24h-ABPM), and blood biomarkers of vascular damage during the first 2 years of T1D diagnosis.

The secondary objectives of the study are to assess changes in body composition, surrogate markers of adiposity (BMI, waist circumference), and dietary intakes during the first 2 years of T1D diagnosis; and to determine the relationships to measures of arterial stiffness, blood pressure, and blood biomarkers of vascular damage. We will also collect sociodemographic data, estimates of physical activity, and glycated hemoglobin (A1C) as an indicator of glycemic control.

Children with a T1D diagnosis aged 8-18 years will be recruited through the Endocrine and Diabetes Unit at BC Children's Hospital (BCCH). Vascular assessments, blood samples, and data will be collected at diagnosis (within 14 weeks of T1D diagnosis; baseline) and at 6, 12, 18, and 24 months post-diagnosis; there will be a total of 5 visits. Each subject will undergo a clinical assessment, interview/questionnaires, blood collection, and cardiovascular assessment.

Statistical Analysis: . Linear regression models will be used to assess changes in 24-h ABPM mean, daytime and nighttime blood pressure, pulse wave velocity, augmentation index, and biomarkers of vascular damage at diagnosis with values collected during the first 24 months post diagnoses. Models will be adjusted for appropriate covariates. To fully understand the biological differences between males and females, data from boys and girls will be analyzed separately.

Conditions

Type 1 Diabetes; Cardiovascular Complications; Child; Adolescent

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Children with Type 1 diabetes

children recruited within 14 weeks of type 1 diabetes diagnosis and followed for 24 months.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Between the ages of 8-18 years

2. Within 14 weeks of type 1 diabetes diagnosis

3. Ability and willingness to undergo non-invasive arterial stiffness assessment for 1hr and willingness to wear the 24-h automated blood pressure monitoring (ABPM) device.

Exclusion Criteria

Children will be ineligible to participate in the study if they meet any of the following:

1. Other cardiometabolic or endocrine diseases diagnosis (type 2 diabetes; familial disorders of cholesterol metabolism; lupus)

2. Other genetic syndromes (Down Syndrome; Prader-Willi)

3. Eating disorder diagnosis

4. Transgender children taking hormone blockers or exogenous sex steroids

5. Currently treated with medications known to affect metabolism (e.g. glucocorticoids, antipsychotics).

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

BC Children's Hospital Research Institute

OTHER

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Angela Devlin

Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Angela Devlin, PhD

Role: PRINCIPAL_INVESTIGATOR

UBC Pediatrics/BC Children's Hospital Research Institute

Constadina Panagiotopoulos, MD

Role: PRINCIPAL_INVESTIGATOR

UBC Pediatrics/BC Children's Hospital Research Institute

Locations

Endocrine and Diabetes Unit, BC Children's Hospital

Vancouver, British Columbia, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Angela Devlin, PhD

Role: CONTACT

adevlin@bcchr.ubc.ca

6048752000 ext. 5378

Constadina Panagiotopoulos, MD

Role: CONTACT

dpanagiotopoulos@cw.bc.ca

Facility Contacts

Gemma Anderson

Role: primary

gemma.anderson@cw.bc.ca

6048752000 ext. 4695

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Other Identifiers

H21-03109

Identifier Type: -

Identifier Source: org_study_id