Recruiting

Observational Study

Sponsor:

University of British Columbia

Code:

NCT05790785

Conditions

Type 1 Diabetes

Cardiovascular Complications

Child

Adolescent

Eligibility Criteria

Sex: All

Age: 8 - 18

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Type 1 Diabetes

Cardiovascular Complications

Child

Adolescent

Study ID

NCT05790785

Start date

Mar 25, 2024

Status verified date

Apr, 2025

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 18

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

Children with Type 1 diabetes

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

Primary outcome measure

  • Change in pulse wave velocity during the first 24 months of type 1 diabetes diagnosis [ Time Frame: Baseline (within 14 weeks of type 1 diabetes diagnosis) and at 6,12, 18 and 24 months post-diagnosis. ]
  • Change in clinic blood pressure during the first 24 months of type 1 diabetes diagnosis [ Time Frame: Baseline (within 14 weeks of type 1 diabetes diagnosis) and at 6,12, 18 and 24 months post-diagnosis. ]
  • Change in augmentation index during the first 24 months of type 1 diabetes diagnosis [ Time Frame: Baseline (within 14 weeks of type 1 diabetes diagnosis) and at 6,12,18 and 24 months post-diagnosis. ]
  • Change in 24-h automated blood pressure monitoring (ABPM) during the first 24 months of type 1 diabetes diagnosis [ Time Frame: Baseline (within 14 weeks of type 1 diabetes diagnosis) and at 12 and 24 months post-diagnosis. ]
  • Change in biomarkers of vascular health during the first 24 months of type 1 diabetes diagnosis [ Time Frame: Baseline (within 14 weeks of type 1 diabetes diagnosis), and at 12 and 24 months post diagnosis. ]

Central Contacts and Locations

Central contacts

Angela Devlin, PhD

6048752000adevlin@bcchr.ubc.ca

Constadina Panagiotopoulos, MD

dpanagiotopoulos@cw.bc.ca

Locations

Endocrine and Diabetes Unit, BC Children's Hospital

Recruiting

Vancouver, British Columbia, Canada, V5Z4H4

Contacts

Gemma Anderson

6048752000gemma.anderson@cw.bc.ca

More Information

Sponsor

University of British Columbia

Last update posted

May 2, 2025

Last verified

Apr, 2025

Keywords

  • Type 1 diabetes
  • Children
  • Arterial stiffness
  • Body composition
  • Biomarkers
  • Nutrition
  • Blood pressure

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2025-05-02.