Understanding Vascular Complications in Children From Type 1 Diabetes Diagnosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change in augmentation index during the first 24 months of type 1 diabetes diagnosis
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in augmentation index during the first 24 months of type 1 diabetes diagnosis
时间窗: 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 pulse wave velocity during the first 24 months of type 1 diabetes diagnosis
时间窗: 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
时间窗: 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 24-h automated blood pressure monitoring (ABPM) during the first 24 months of type 1 diabetes diagnosis
时间窗: 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
时间窗: 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.
次要结局
- 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.)
- Nutritional assessment(Baseline (within 14 weeks of type 1 diabetes diagnosis) and at 12 and 24 months post-diagnosis.)
- Glycated hemoglobin (A1C)(Baseline (within 14 weeks of type 1 diabetes diagnosis) and at 6,12,18 and 24 months post-diagnosis.)
- Body composition(Baseline (within 14 weeks of type 1 diabetes diagnosis) and at 6,12,18 and 24 months post-diagnosis.)
- Height(Baseline (within 14 weeks of type 1 diabetes diagnosis) and at 6,12,18 and 24 months post-diagnosis.)
- Waist circumference(Baseline (within 14 weeks of type 1 diabetes diagnosis) and at 6,12,18 and 24 months post-diagnosis.)
- Smoking and substance use(Baseline (within 14 weeks of type 1 diabetes diagnosis) and at 6,12,18 and 24 months post-diagnosis.)
研究者
Angela Devlin
Professor of Pediatrics
University of British Columbia