Vascular Complications in Children From T1D Diagnosis

NCT05790785 | Recruiting

• 1 other identifier: H21-03109
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (5)

• Change in pulse wave velocity during the first 24 months of type 1 diabetes diagnosis

  Carotid-femoral pulse wave velocity (PWV) will be measured with a SphygmoCor® XCEL System (AtCor Medical Pty Ltd).

  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

  Systolic and diastolic blood pressure measures (average of 3 readings) will be collected using a Dinamap automated monitor (PRO 100-400, GE Medical Systems) and an appropriately sized cuff. Values will be standardized for age, sex, and height using the 2017 American Academy of Pediatrics guidelines.

  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

  Augmentation index will be measured with a SphygmoCor® XCEL System (AtCor Medical Pty Ltd).

  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

  Children will wear a 24h-ABMP (SpaceLabs) that measures blood pressure every 20 minutes for 24 hours. This will allow for any abnormalities not detected in the clinic to be identified (e.g. masked hypertension). Data will be standardized and categorized according to the 2022 American Academy of Pediatrics guidelines.

  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

  Blood biomarkers of vascular health will be assessed in plasma, serum and PBMCs. This includes: a) E-selectin, intracellular adhesion molecule 1 (ICAM), vascular cellular adhesion molecule 1 (VCAM), and von Willebrand factor (vWF) will be quantified as circulating indicators of endothelial damage. b) C-reactive protein (CRP), interleukin (IL)-6, IL-8, monocyte chemotactic protein-1 (MCP-1), isoprostane and tumor necrosis factor alpha (TNFα) will be quantified as indicators of inflammation. c) Creatinine and total homocysteine will be quantified as indicators of kidney function; d) genome wide DNA methylation patters in PBMCs.

  Baseline (within 14 weeks of type 1 diabetes diagnosis), and at 12 and 24 months post diagnosis.

Secondary Outcomes (11)

• Sociodemographic information

  Baseline (within 14 weeks of type 1 diabetes diagnosis). Family history of cardiovascular disease and diabetes and gender will also be assessed at 6, 12, 18, and 24 months.

• Puberty Status

  Baseline (within 14 weeks of type 1 diabetes diagnosis), and 12 and 24 months post diagnosis.

• Body weight

  Baseline (within 14 weeks of type 1 diabetes diagnosis) and at 6,12,18 and 24 months post-diagnosis.

• BMI

  Baseline (within 14 weeks of type 1 diabetes diagnosis) and at 6,12,18 and 24 months post-diagnosis.

• Physical activity

  Baseline (within 14 weeks of type 1 diabetes diagnosis) and at 6,12,18 and 24 months post-diagnosis.

Study Arms (1)

Children with Type 1 diabetes

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

Eligibility Criteria

• Age: 8 Years - 18 Years
• Gender Eligibility Details: Transgender children taking hormone blockers or exogenous sex steroids will be excluded because of the potential effect on metabolic health.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children will be recruited within 14 weeks of type 1 diabetes diagnosis through the Endocrine and Diabetes Unit at BC Children's Hospital.

You may qualify if:

• Between the ages of 8-18 years
• Within 14 weeks of type 1 diabetes diagnosis
• 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.

You may not qualify if:

• Children will be ineligible to participate in the study if they meet any of the following:
• Other cardiometabolic or endocrine diseases diagnosis (type 2 diabetes; familial disorders of cholesterol metabolism; lupus)
• Other genetic syndromes (Down Syndrome; Prader-Willi)
• Eating disorder diagnosis
• Transgender children taking hormone blockers or exogenous sex steroids
• Currently treated with medications known to affect metabolism (e.g. glucocorticoids, antipsychotics).

Sponsors & Collaborators

• University of British Columbia: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• BC Children's Hospital Research Institute: collaborator

Study Sites (1)

Endocrine and Diabetes Unit, BC Children's Hospital

Vancouver, British Columbia, V5Z4H4, Canada

RECRUITING

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Biospecimen

Retention: SAMPLES WITH DNA

Venous blood samples (20ml) will be collected to evaluate biomarkers of vascular damage. Serum, plasma, and PBMCs will be obtained from the blood samples.

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

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

Study Officials

• Angela Devlin, PhD

  UBC Pediatrics/BC Children's Hospital Research Institute

  PRINCIPAL INVESTIGATOR

• Constadina Panagiotopoulos, MD

  UBC Pediatrics/BC Children's Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angela Devlin, PhD

CONTACT

6048752000; adevlin@bcchr.ubc.ca

Constadina Panagiotopoulos, MD

CONTACT

dpanagiotopoulos@cw.bc.ca

Study Design

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

Study Record Dates

• First Submitted: August 4, 2022
• First Posted: March 30, 2023
• Study Start: March 25, 2024
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: May 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data will be available after the study is completed (Dec 2026).
• Access Criteria: Written requests specifying need to access the data should be made to the co-PIs: Dr Angela Devlin and Dr Dina Panagiotopoulos

Locations

CA (1)