Type 1 DiabetesNCT05790785
Vascular Complications in Children From T1D Diagnosis
An observational study of Type 1 Diabetes and Cardiovascular Complications, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Type 1 Diabetes, Cardiovascular Complications, Child
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- 25 Mar 2024to 30 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Constadina Panagiotopoulos, MD contact
Canada1 site, 1 recruiting
- Recruiting
Endocrine and Diabetes Unit, BC Children's Hospital
Vancouver, British Columbia, V5Z4H4
Gemma Anderson, 6048752000 ext. 4695, gemma.anderson@cw.bc.ca
About this study
Official title: Understanding Vascular Complications in Children From Type 1 Diabetes Diagnosis
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.
Read the 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
- Keywords
- Type 1 diabetes, Children, Arterial stiffness, Body composition, Biomarkers, Nutrition, Blood pressure
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children with Type 1 diabetes | children recruited within 14 weeks of type 1 diabetes diagnosis and followed for 24 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
- 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.
- Creatinine and total homocysteine will be quantified as indicators of kidney function; d) genome wide DNA methylation patters in PBMCs.
Measured: Baseline (within 14 weeks of type 1 diabetes diagnosis), and at 12 and 24 months post diagnosis.
Secondary outcomes (11)
Sociodemographic information
Sociodemographic information will be collected including: age, sex, gender, self-reported ethnicity, and family medical history of cardiovascular disease. and diabetes.
Measured: 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
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.
Measured: Baseline (within 14 weeks of type 1 diabetes diagnosis), and 12 and 24 months post diagnosis.
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.
Measured: Baseline (within 14 weeks of type 1 diabetes diagnosis) and at 6,12,18 and 24 months post-diagnosis.
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.
Measured: Baseline (within 14 weeks of type 1 diabetes diagnosis) and at 6,12,18 and 24 months post-diagnosis.
Physical activity
Physical activity questionnaire (PAQ) will be administered to quantify relative levels of daily physical activity. There are two versions of the questionnaires: one for elementary school aged children and the second for high school aged children. Participants will be given the questionnaire that corresponds with whether they are in elementary school or high school .
Measured: Baseline (within 14 weeks of type 1 diabetes diagnosis) and at 6,12,18 and 24 months post-diagnosis.
Nutritional assessment
3x 24-hr dietary recalls will be used to assess dietary intakes. We will conduct 3 dietary recalls for 3 non-consecutive days. The first dietary recall will be will be conducted in person by a member of the research staff during the study visit. The other two diary recalls will be completed over the phone. During the in-person dietary recall, the participants and their parents/caregivers will be shown food models, plates, bowls, cups, and spoons to help them better gauge the amounts of foods and beverages consumed.
Measured: Baseline (within 14 weeks of type 1 diabetes diagnosis) and at 12 and 24 months post-diagnosis.
Glycated hemoglobin (A1C)
Blood A1C levels will be measured to assess glycemic control over the past few months. The values for each time point will be obtained from the clinical charts.
This is routinely done at clinic visits, thus we will obtain this information from medical chart
Measured: Baseline (within 14 weeks of type 1 diabetes diagnosis) and at 6,12,18 and 24 months post-diagnosis.
Body composition
Body composition will be assessed by Dual-energy X-ray absorptiometry (DEXA) scan (Horizon® Hologic Inc). The percent lean and fat mass and bone density will be calculated from the scans.
Measured: Baseline (within 14 weeks of type 1 diabetes diagnosis) and at 6,12,18 and 24 months post-diagnosis.
Height
Height will be measured in the children wearing no shoes. Height will be recorded to the nearest 0.1 cm with a stadiometer.
Measured: Baseline (within 14 weeks of type 1 diabetes diagnosis) and at 6,12,18 and 24 months post-diagnosis.
Waist circumference
Waist circumference will be assessed using a non-elastic flexible tape measure at the level of the umbilicus. The values will be standardized for sex and age (z-score) according to Sharma et al.
Measured: Baseline (within 14 weeks of type 1 diabetes diagnosis) and at 6,12,18 and 24 months post-diagnosis.
Smoking and substance use
Smoking and substance use will be collected as self-reported through direct interview with the subject/family. Collecting this information will allow us to assess the potential impact of smoking habits on vascular health. In addition, tobacco, vaping, e-cigarette, and cannabis use has been described to influence appetite and may affect dietary habits.
Measured: Baseline (within 14 weeks of type 1 diabetes diagnosis) and at 6,12,18 and 24 months post-diagnosis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start25 Mar 2024
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), BC Children's Hospital Research Institute
- Responsible party
- Principal investigator, Angela Devlin, University of British Columbia
- Investigators
- Angela Devlin, PhD, Principal investigator, UBC Pediatrics/BC Children's Hospital Research InstituteConstadina Panagiotopoulos, MD, Principal investigator, UBC Pediatrics/BC Children's Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05790785
- Sponsor's protocol ID
- H21-03109
- Status last verified
- Apr 2025
- First submitted
- 4 Aug 2022
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Soedamah-Muthu SS, Fuller JH, Mulnier HE, Raleigh VS, Lawrenson RA, Colhoun HM. High risk of cardiovascular disease in patients with type 1 diabetes in the U.K.: a cohort study using the general practice research database. Diabetes Care. 2006 Apr;29(4):798-804. doi: 10.2337/diacare.29.04.06.dc05-1433.
PubMed 16567818Deckert T, Poulsen JE, Larsen M. Prognosis of diabetics with diabetes onset before the age of thirty-one. I. Survival, causes of death, and complications. Diabetologia. 1978 Jun;14(6):363-70. doi: 10.1007/BF01228130. No abstract available.
PubMed 669100Secrest AM, Becker DJ, Kelsey SF, Laporte RE, Orchard TJ. Cause-specific mortality trends in a large population-based cohort with long-standing childhood-onset type 1 diabetes. Diabetes. 2010 Dec;59(12):3216-22. doi: 10.2337/db10-0862. Epub 2010 Aug 25.
PubMed 20739685Krolewski AS, Kosinski EJ, Warram JH, Leland OS, Busick EJ, Asmal AC, Rand LI, Christlieb AR, Bradley RF, Kahn CR. Magnitude and determinants of coronary artery disease in juvenile-onset, insulin-dependent diabetes mellitus. Am J Cardiol. 1987 Apr 1;59(8):750-5. doi: 10.1016/0002-9149(87)91086-1.
PubMed 3825934Libby P, Nathan DM, Abraham K, Brunzell JD, Fradkin JE, Haffner SM, Hsueh W, Rewers M, Roberts BT, Savage PJ, Skarlatos S, Wassef M, Rabadan-Diehl C; National Heart, Lung, and Blood Institute; National Institute of Diabetes and Digestive and Kidney Diseases Working Group on Cardiovascular Complications of Type 1 Diabetes Mellitus. Report of the National Heart, Lung, and Blood Institute-National Institute of Diabetes and Digestive and Kidney Diseases Working Group on Cardiovascular Complications of Type 1 Diabetes Mellitus. Circulation. 2005 Jun 28;111(25):3489-93. doi: 10.1161/CIRCULATIONAHA.104.529651. No abstract available.
PubMed 15983263Glackin S, Islam N, Henderson AM, Dionne JM, Harris KC, Panagiotopoulos C, Devlin AM. Ambulatory blood pressure and carotid intima media thickness in children with type 1 diabetes. Pediatr Diabetes. 2020 Mar;21(2):358-365. doi: 10.1111/pedi.12960. Epub 2019 Dec 26.
PubMed 31825119Flynn JT, Daniels SR, Hayman LL, Maahs DM, McCrindle BW, Mitsnefes M, Zachariah JP, Urbina EM; American Heart Association Atherosclerosis, Hypertension and Obesity in Youth Committee of the Council on Cardiovascular Disease in the Young. Update: ambulatory blood pressure monitoring in children and adolescents: a scientific statement from the American Heart Association. Hypertension. 2014 May;63(5):1116-35. doi: 10.1161/HYP.0000000000000007. Epub 2014 Mar 3. No abstract available.
PubMed 24591341Wiltshire EJ, Gent R, Hirte C, Pena A, Thomas DW, Couper JJ. Endothelial dysfunction relates to folate status in children and adolescents with type 1 diabetes. Diabetes. 2002 Jul;51(7):2282-6. doi: 10.2337/diabetes.51.7.2282.
PubMed 12086961Jarvisalo MJ, Raitakari M, Toikka JO, Putto-Laurila A, Rontu R, Laine S, Lehtimaki T, Ronnemaa T, Viikari J, Raitakari OT. Endothelial dysfunction and increased arterial intima-media thickness in children with type 1 diabetes. Circulation. 2004 Apr 13;109(14):1750-5. doi: 10.1161/01.CIR.0000124725.46165.2C. Epub 2004 Mar 15.
PubMed 15023875Jarvisalo MJ, Putto-Laurila A, Jartti L, Lehtimaki T, Solakivi T, Ronnemaa T, Raitakari OT. Carotid artery intima-media thickness in children with type 1 diabetes. Diabetes. 2002 Feb;51(2):493-8. doi: 10.2337/diabetes.51.2.493.
PubMed 11812760Singh TP, Groehn H, Kazmers A. Vascular function and carotid intimal-medial thickness in children with insulin-dependent diabetes mellitus. J Am Coll Cardiol. 2003 Feb 19;41(4):661-5. doi: 10.1016/s0735-1097(02)02894-2.
PubMed 12598080Krantz JS, Mack WJ, Hodis HN, Liu CR, Liu CH, Kaufman FR. Early onset of subclinical atherosclerosis in young persons with type 1 diabetes. J Pediatr. 2004 Oct;145(4):452-7. doi: 10.1016/j.jpeds.2004.06.042.
PubMed 15480366Heilman K, Zilmer M, Zilmer K, Lintrop M, Kampus P, Kals J, Tillmann V. Arterial stiffness, carotid artery intima-media thickness and plasma myeloperoxidase level in children with type 1 diabetes. Diabetes Res Clin Pract. 2009 May;84(2):168-73. doi: 10.1016/j.diabres.2009.01.014. Epub 2009 Feb 23.
PubMed 19237222Ciftel M, Ertug H, Parlak M, Akcurin G, Kardelen F. Investigation of endothelial dysfunction and arterial stiffness in children with type 1 diabetes mellitus and the association with diastolic dysfunction. Diab Vasc Dis Res. 2014 Jan;11(1):19-25. doi: 10.1177/1479164113508564. Epub 2013 Oct 29.
PubMed 24169808Babar GS, Zidan H, Widlansky ME, Das E, Hoffmann RG, Daoud M, Alemzadeh R. Impaired endothelial function in preadolescent children with type 1 diabetes. Diabetes Care. 2011 Mar;34(3):681-5. doi: 10.2337/dc10-2134. Epub 2011 Feb 2.
PubMed 21289230
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Vascular Complications in Children From Type 1 Diabetes Diagnosis
- ClinicalTrials.gov ID
- NCT05790785
- Acronym / sponsor ID
- H21-03109
- Conditions
- Type 1 Diabetes, Cardiovascular Complications, Child, Adolescent
- Keywords
- Type 1 diabetes, Children, Arterial stiffness, Body composition, Biomarkers, Nutrition, Blood pressure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), BC Children's Hospital Research Institute
- Study start
- 25 Mar 2024 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 30 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with Type 1 diabetes | – | –children recruited within 14 weeks of type 1 diabetes diagnosis and followed for 24 months. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Carotid-femoral pulse wave velocity (PWV) will be measured with a SphygmoCor® XCEL System (AtCor Medical Pty Ltd).
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.
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.
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.
Augmentation index will be measured with a SphygmoCor® XCEL System (AtCor Medical Pty Ltd).
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.
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.
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.
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.
11 secondary outcomes
Sociodemographic information
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.
Puberty Status
Time frame: Baseline (within 14 weeks of type 1 diabetes diagnosis), and 12 and 24 months post diagnosis.
Body weight
Time frame: Baseline (within 14 weeks of type 1 diabetes diagnosis) and at 6,12,18 and 24 months post-diagnosis.
BMI
Time frame: Baseline (within 14 weeks of type 1 diabetes diagnosis) and at 6,12,18 and 24 months post-diagnosis.
Physical activity
Time frame: Baseline (within 14 weeks of type 1 diabetes diagnosis) and at 6,12,18 and 24 months post-diagnosis.
Nutritional assessment
Time frame: Baseline (within 14 weeks of type 1 diabetes diagnosis) and at 12 and 24 months post-diagnosis.
Glycated hemoglobin (A1C)
Time frame: Baseline (within 14 weeks of type 1 diabetes diagnosis) and at 6,12,18 and 24 months post-diagnosis.
Body composition
Time frame: Baseline (within 14 weeks of type 1 diabetes diagnosis) and at 6,12,18 and 24 months post-diagnosis.
Height
Time frame: Baseline (within 14 weeks of type 1 diabetes diagnosis) and at 6,12,18 and 24 months post-diagnosis.
Waist circumference
Time frame: Baseline (within 14 weeks of type 1 diabetes diagnosis) and at 6,12,18 and 24 months post-diagnosis.
Smoking and substance use
Time frame: Baseline (within 14 weeks of type 1 diabetes diagnosis) and at 6,12,18 and 24 months post-diagnosis.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Background: PubMed 16567818Soedamah-Muthu SS, Fuller JH, Mulnier HE, Raleigh VS, Lawrenson RA, Colhoun HM. High risk of cardiovascular disease in patients with type 1 diabetes in the U.K.: a cohort study using the general practice research database. Diabetes Care. 2006 Apr;29(4):798-804. doi: 10.2337/diacare.29.04.06.dc05-1433.
- Background: PubMed 669100Deckert T, Poulsen JE, Larsen M. Prognosis of diabetics with diabetes onset before the age of thirty-one. I. Survival, causes of death, and complications. Diabetologia. 1978 Jun;14(6):363-70. doi: 10.1007/BF01228130. No abstract available.
- Background: PubMed 20739685Secrest AM, Becker DJ, Kelsey SF, Laporte RE, Orchard TJ. Cause-specific mortality trends in a large population-based cohort with long-standing childhood-onset type 1 diabetes. Diabetes. 2010 Dec;59(12):3216-22. doi: 10.2337/db10-0862. Epub 2010 Aug 25.
- Background: PubMed 3825934Krolewski AS, Kosinski EJ, Warram JH, Leland OS, Busick EJ, Asmal AC, Rand LI, Christlieb AR, Bradley RF, Kahn CR. Magnitude and determinants of coronary artery disease in juvenile-onset, insulin-dependent diabetes mellitus. Am J Cardiol. 1987 Apr 1;59(8):750-5. doi: 10.1016/0002-9149(87)91086-1.
- Background: PubMed 15983263Libby P, Nathan DM, Abraham K, Brunzell JD, Fradkin JE, Haffner SM, Hsueh W, Rewers M, Roberts BT, Savage PJ, Skarlatos S, Wassef M, Rabadan-Diehl C; National Heart, Lung, and Blood Institute; National Institute of Diabetes and Digestive and Kidney Diseases Working Group on Cardiovascular Complications of Type 1 Diabetes Mellitus. Report of the National Heart, Lung, and Blood Institute-National Institute of Diabetes and Digestive and Kidney Diseases Working Group on Cardiovascular Complications of Type 1 Diabetes Mellitus. Circulation. 2005 Jun 28;111(25):3489-93. doi: 10.1161/CIRCULATIONAHA.104.529651. No abstract available.
- Background: PubMed 31825119Glackin S, Islam N, Henderson AM, Dionne JM, Harris KC, Panagiotopoulos C, Devlin AM. Ambulatory blood pressure and carotid intima media thickness in children with type 1 diabetes. Pediatr Diabetes. 2020 Mar;21(2):358-365. doi: 10.1111/pedi.12960. Epub 2019 Dec 26.
- Background: PubMed 24591341Flynn JT, Daniels SR, Hayman LL, Maahs DM, McCrindle BW, Mitsnefes M, Zachariah JP, Urbina EM; American Heart Association Atherosclerosis, Hypertension and Obesity in Youth Committee of the Council on Cardiovascular Disease in the Young. Update: ambulatory blood pressure monitoring in children and adolescents: a scientific statement from the American Heart Association. Hypertension. 2014 May;63(5):1116-35. doi: 10.1161/HYP.0000000000000007. Epub 2014 Mar 3. No abstract available.
- Background: PubMed 12086961Wiltshire EJ, Gent R, Hirte C, Pena A, Thomas DW, Couper JJ. Endothelial dysfunction relates to folate status in children and adolescents with type 1 diabetes. Diabetes. 2002 Jul;51(7):2282-6. doi: 10.2337/diabetes.51.7.2282.
- Background: PubMed 15023875Jarvisalo MJ, Raitakari M, Toikka JO, Putto-Laurila A, Rontu R, Laine S, Lehtimaki T, Ronnemaa T, Viikari J, Raitakari OT. Endothelial dysfunction and increased arterial intima-media thickness in children with type 1 diabetes. Circulation. 2004 Apr 13;109(14):1750-5. doi: 10.1161/01.CIR.0000124725.46165.2C. Epub 2004 Mar 15.
- Background: PubMed 11812760Jarvisalo MJ, Putto-Laurila A, Jartti L, Lehtimaki T, Solakivi T, Ronnemaa T, Raitakari OT. Carotid artery intima-media thickness in children with type 1 diabetes. Diabetes. 2002 Feb;51(2):493-8. doi: 10.2337/diabetes.51.2.493.
- Background: PubMed 12598080Singh TP, Groehn H, Kazmers A. Vascular function and carotid intimal-medial thickness in children with insulin-dependent diabetes mellitus. J Am Coll Cardiol. 2003 Feb 19;41(4):661-5. doi: 10.1016/s0735-1097(02)02894-2.
- Background: PubMed 15480366Krantz JS, Mack WJ, Hodis HN, Liu CR, Liu CH, Kaufman FR. Early onset of subclinical atherosclerosis in young persons with type 1 diabetes. J Pediatr. 2004 Oct;145(4):452-7. doi: 10.1016/j.jpeds.2004.06.042.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Constadina Panagiotopoulos, MD contact
Angela Devlin, PhD principal investigator
UBC Pediatrics/BC Children's Hospital Research Institute
Constadina Panagiotopoulos, MD principal investigator
UBC Pediatrics/BC Children's Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes and Cardiovascular Complications, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Angela Devlin, PhD (6048752000 ext. 5378, adevlin@bcchr.ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05790785, which also lists 32 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2025.