Vascular Complications in Children From T1D Diagnosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age8-18
SponsorUniversity of British Columbia
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial population
Children will be recruited within 14 weeks of type 1 diabetes diagnosis through the Endocrine and Diabetes Unit at BC Children's Hospital.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
150 Participants
are grouped into 1 trial groupGroup A: Children with Type 1 diabetes
Trial outcomes
Primary outcomes
1
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).
Time frame
Baseline (within 14 weeks of type 1 diabetes diagnosis) and at 6,12, 18 and 24 months post-diagnosis.2
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.
Time frame
Baseline (within 14 weeks of type 1 diabetes diagnosis) and at 6,12, 18 and 24 months post-diagnosis.3
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).
Time frame
Baseline (within 14 weeks of type 1 diabetes diagnosis) and at 6,12,18 and 24 months post-diagnosis.4
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.
Time frame
Baseline (within 14 weeks of type 1 diabetes diagnosis) and at 12 and 24 months post-diagnosis.Secondary outcomes
1
Sociodemographic information
Sociodemographic information will be collected including: age, sex, gender, self-reported ethnicity, and family medical history of cardiovascular disease. and diabetes.
Time frame
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.2
Puberty Status
Pubertal development (Tanner stage) will be evaluated by self-reported Tanner staging. The form used for the self-report development stage will be provided to participants according to their sex at birth.
Time frame
Baseline (within 14 weeks of type 1 diabetes diagnosis), and 12 and 24 months post diagnosis.3
Body weight
Body weight will be measured measured in children wearing light clothing, pockets emptied, and without shoes using a balance scale. Weight will be recorded to the nearest 0.1 kg.
Time frame
Baseline (within 14 weeks of type 1 diabetes diagnosis) and at 6,12,18 and 24 months post-diagnosis.4
BMI
Body mass index (BMI) will be calculated using weight and height measures \[weight (kg)/height (m2)\] and standardized for sex and age (z-score and percentile) according to WHO growth reference charts.
Time frame
Baseline (within 14 weeks of type 1 diabetes diagnosis) and at 6,12,18 and 24 months post-diagnosis.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of British Columbia
Lead sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
BC Children's Hospital Research Institute
Collaborator
Source ClinicalTrials.gov