Clinical trial NCT05790785: Vascular Complications in Children From T1D Diagnosis
Official title: Understanding Vascular Complications in Children From Type 1 Diabetes Diagnosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Type 1 Diabetes
Cardiovascular Complications
Child
Adolescent
Keywords: Type 1 diabetes
Children
Arterial stiffness
Body composition
Biomarkers
Nutrition
Blood pressure
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: BC Children's Hospital Research Institute
First posted: 2023-03-30
Enrollment: 150
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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).

Primary outcomes:
measure: Change in pulse wave velocity during the first 24 months of type 1 diabetes diagnosis
timeFrame: Baseline (within 14 weeks of type 1 diabetes diagnosis) and at 6,12, 18 and 24 months post-diagnosis.
measure: Change in clinic blood pressure during the first 24 months of type 1 diabetes diagnosis
timeFrame: Baseline (within 14 weeks of type 1 diabetes diagnosis) and at 6,12, 18 and 24 months post-diagnosis.
measure: Change in augmentation index during the first 24 months of type 1 diabetes diagnosis
timeFrame: Baseline (within 14 weeks of type 1 diabetes diagnosis) and at 6,12,18 and 24 months post-diagnosis.
measure: Change in 24-h automated blood pressure monitoring (ABPM) during the first 24 months of type 1 diabetes diagnosis
timeFrame: Baseline (within 14 weeks of type 1 diabetes diagnosis) and at 12 and 24 months post-diagnosis.
measure: Change in biomarkers of vascular health during the first 24 months of type 1 diabetes diagnosis
timeFrame: Baseline (within 14 weeks of type 1 diabetes diagnosis), and at 12 and 24 months post diagnosis.
Secondary outcomes:
measure: Sociodemographic information
timeFrame: 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.
measure: Puberty Status
timeFrame: Baseline (within 14 weeks of type 1 diabetes diagnosis), and 12 and 24 months post diagnosis.
measure: Body weight
timeFrame: Baseline (within 14 weeks of type 1 diabetes diagnosis) and at 6,12,18 and 24 months post-diagnosis.
measure: BMI
timeFrame: Baseline (within 14 weeks of type 1 diabetes diagnosis) and at 6,12,18 and 24 months post-diagnosis.
measure: Physical activity
timeFrame: Baseline (within 14 weeks of type 1 diabetes diagnosis) and at 6,12,18 and 24 months post-diagnosis.
measure: Nutritional assessment
timeFrame: Baseline (within 14 weeks of type 1 diabetes diagnosis) and at 12 and 24 months post-diagnosis.
measure: Glycated hemoglobin (A1C)
timeFrame: Baseline (within 14 weeks of type 1 diabetes diagnosis) and at 6,12,18 and 24 months post-diagnosis.
measure: Body composition
timeFrame: Baseline (within 14 weeks of type 1 diabetes diagnosis) and at 6,12,18 and 24 months post-diagnosis.
measure: Height
timeFrame: Baseline (within 14 weeks of type 1 diabetes diagnosis) and at 6,12,18 and 24 months post-diagnosis.
measure: Waist circumference
timeFrame: Baseline (within 14 weeks of type 1 diabetes diagnosis) and at 6,12,18 and 24 months post-diagnosis.
measure: Smoking and substance use
timeFrame: Baseline (within 14 weeks of type 1 diabetes diagnosis) and at 6,12,18 and 24 months post-diagnosis.
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Endocrine and Diabetes Unit, BC Children's Hospital
state: British Columbia
Study officials:
affiliation: UBC Pediatrics/BC Children's Hospital Research Institute
name: Angela Devlin, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UBC Pediatrics/BC Children's Hospital Research Institute
name: Constadina Panagiotopoulos, MD
role: PRINCIPAL_INVESTIGATOR
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