NCT05790785

Vascular Complications in Children From T1D Diagnosis

Understanding Vascular Complications in Children From Type 1 Diabetes Diagnosis

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: University of British Columbia · Academic / Other
• Sex: All
• Age: 8 Years – 18 Years
• Healthy volunteers: Not accepted

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

Timeline

• Start date: 2024-03-25
• Primary completion: 2027-09-30
• Completion: 2027-09-30
• First posted: 2023-03-30
• Last updated: 2025-05-02

Locations

1 site across 1 country: Canada