Prevalence of Oxidative Stress, Endothelial Dysfunction, Increased Carotid Artery Intima-media Thickness (cIMT) and Biomarkers of Vascular Inflammation in Adolescents With Type-1 Diabetes Mellitus (T1DM)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Determine the impact of glycemic control on vascular oxidative stress/inflammation in adolescents with Type 1 diabetes mellitus
研究概览
简要总结
The purpose of this study is to find out if diabetes damages the blood vessels of adolescents with good diabetes control compared to adolescents with less optimal control.
详细描述
Many published studies reveal that adult patients with T1DM can have early, silent and more advanced vessel wall thickness than normal subjects. This is influenced by the degree of their blood sugar control. If this is happening in adolescents, we want to know what proportion of adolescent children with type 1 diabetes show signs of early blood vessel damage. We also want to learn if these signs of damage are linked to other factors such as how long someone has had diabetes, blood sugar control or individual differences because of a difference in genetic make-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adolescents ages 12-18 years
- •Tanner stage III-V
- •T1DM > 2 years
- •HgbA1c <8 or >10 for previous 2 years
排除标准
- •Subjects with known history of hypercholesterolemia or family history of hypercholesterolemia
- •Family history of premature cardiovascular disease
- •Hypertension defined as subjects with blood pressure greater than the 90th percentile for age
- •Anemia defined as Hgb <11.0 g/dl
- •Congenital heart disease
- •Pituitary tumor
- •Known allergy to ultrasound gel
- •Recent head injury
- •Chromosomal abnormalities
结局指标
主要结局
Determine the impact of glycemic control on vascular oxidative stress/inflammation in adolescents with Type 1 diabetes mellitus
时间窗: 1 year
次要结局
- To determine the impact of glycemic control and vascular oxidative stress/inflammation on vascular health in adolescents with T1DM(1 year)