Influence of Vitamin D on Vascular Function in Adolescents and Young Adults With Type 1 Diabetes
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Change in Endothelial Function after Treatment with Vitamin D
研究概览
简要总结
The purpose of this study is to study the role of low vitamin D levels on the health of blood vessels or vascular function in adolescents and young adults with type 1 diabetes.
详细描述
Vitamin D deficiency is known to be common in patients with type 1 diabetes. Studies in adults have shown that vitamin D deficiency is associated with cardiovascular events such as stroke, myocardial infarction and peripheral arterial disease. However, the impact of this deficiency on vascular health in adolescents with diabetes has not been examined. Furthermore given that endothelial dysfunction is reversible, early detection of this process may have therapeutic and prognostic implications in this population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Diagnosed with type 1 diabetes, according to Canadian Diabetes Association guidelines
- •Diagnosed with type 1 diabetes for at least 2 years
- •Between the ages of 12 and 18 years
排除标准
- •Previous organ transplantation
- •Diagnosed with familial hypercholesterolemia
- •Active smoker
- •Receiving lipid lowering medications
- •Receiving anti hypertensive medication
- •Significant chronic medical illness, including granulomatous disease
- •History of hypertension
- •BMI >95%tile
- •Known renal failure
- •HbA1c greater than 12% on two successive occasions
- •Known peripheral vascular disease
- •Known hypercalcemia
研究组 & 干预措施
Vitamin D Sufficient
Sufficient is defined as a 25 OH vitamin D level >50 nmol/l measured at baseline. No clinical intervention will be assigned to this group.
Subjects will have fasting bloodwork done. Other study measurements to be taken include: height and weight, stage of puberty, blood pressure, vitamin D and calcium intake information, diabetes risk information, demographic information and spot urine sample.
We will also do a non-invasive test called a "PAT" or 'peripheral arterial tonometry' to look at the health of your blood vessels.
Vitamin D Deficient
Deficient is defined as a 25 OH vitamin D level ≤ 37.5 nmol/l. This group will receive Vitamin D.
Subjects will have fasting bloodwork done. Other study measurements to be taken include: height and weight, stage of puberty, blood pressure, vitamin D and calcium intake information, diabetes risk information, demographic information and spot urine sample.
We will also do a non-invasive test called a "PAT" or 'peripheral arterial tonometry' to look at the health of your blood vessels.
干预措施: Vitamin D (Dietary Supplement)
结局指标
主要结局
Change in Endothelial Function after Treatment with Vitamin D
时间窗: Baseline, 3 or 6 months
We will measure the change in endothelial function from baseline in the children that were vitamin D deficient. This measurement will be done once the child has become vitamin D sufficient. Vitamin D status will be assessed at 3 months. If the levels remain deficient treatment would continue for another 3 months, with repeat testing at 6 months. Endothelial function will be assessed by peripheral arterial tonometry (PAT) which measures the elasticity of the arteries.
Comparison of Endothelial Function
时间窗: Baseline
We will compare endothelial function in adolescents with type 1 diabetes divided into 2 groups on the basis of vitamin D status (deficient and sufficient). Endothelial function will be assessed by peripheral arterial tonometry (PAT) which measures the elasticity of the arteries.
次要结局
- Comparison of Urinary Albumin/Creatinine Ratio(Baseline)
- Monitoring of Vitamin D Levels in Vitamin D deficient subjects(2-3 months)
- Comparison of Systemic Blood Pressure(Baseline)
- Monitoring of Calcium Creatine Ratio in Vitamin D deficient subjects(2-3 months)
研究者
Farid Mahmud
Staff Physician
The Hospital for Sick Children