Sexual Dimorphism in the Prevalence and Progression of Cardiovascular Autonomic Neuropathy in Patients With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- To address sexual dimorphism in subclinical atherosclerosis in patients with T1D.
研究概览
简要总结
Sex might interact with cardioautonomic neuropathy (CAN) in the development of macrovascular disease in patients with type 1 diabetes (T1D). The regulation of the autonomic system shows sexual dimorphism, and may contribute to the cardiovascular risk overload in women with T1D.
The aims of this project are:
A.1) Determining the prevalence of CAN and subclinical atherosclerosis in a large cohort of consecutive patients with T1D as a function of sex (cross-sectional study).
A.2.) Addressing the progression of CAN and subclinical atherosclerosis in patients with T1D as a function of sex (longitudinal prospective study).
A.3.) Investigating the influence of sex steroids and circulating biomarkers in the development and progression of CAN and subclinical atherosclerosis.
Research designs:
A cross-sectional design/prevalence screening study determining the prevalence of CAN as a function of sex in 320 consecutive individuals with DM1.
A longitudinal prospective study: the cohort of prevalence screening study will be prospectively followed, and the assessment of cardiovascular autonomic function and subclinical atherosclerosis will be repeated over time.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of type 1 diabetes mellitus, as defined by ADA criteria
排除标准
- •Renal transplantation or renal replacement therapy;
- •prior diagnosis of macrovascular disease (CHD, cerebrovascular disease, carotid disease, PAD, or atherosclerotic aortic aneurism);
- •ongoing pregnancy;
- •diagnosis of types of diabetes mellitus other than type 1;
- •diagnosis of types of neuropathy other than diabetic neuropathy.
结局指标
主要结局
To address sexual dimorphism in subclinical atherosclerosis in patients with T1D.
时间窗: Two years
Mean carotid intima-media thickness (mm)
To address sexual dimorphism in the prevalence of CAN in patients with T1D.
时间窗: Two years
Heart rate responses (bpm) to active standing and Ewing and Clarke tests.
To assess the role of sex on the progression of cardiovascular dysautonomy in patients with T1D.
时间窗: Four years
Heart rate responses (bpm) to active standing and Ewing and Clarke tests.
To assess the role of sex on the progression of subclinical atherosclerosis in patients with T1D.
时间窗: Four years
Mean carotid intima-media thickness (mm)
次要结局
- To identify the influence of sex steroids on the evolution of cardiac autonomic dysfunction.(Four years)
- To identify novel circulating markers of subclinical atherosclerosis(Four years)
- To identify the influence of sex steroids on the evolution of subclinical atherosclerosis(Four years)
- To identify novel circulating markers of CAN(Four years)