Sex Hormone and Vascular Function in Women With CKD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Brachial Artery Flow-Mediated Dilation
研究概览
简要总结
The risk of cardiovascular disease (CVD) is significantly elevated in patients with chronic kidney disease (CKD). Notably, women with CKD commonly experience menstrual disturbances induced by CKD, which may contribute to impaired vascular function and elevated CVD risk. However, most of the literature in the field of nephrology focuses on male patients, and studies on women's vascular health are limited. Moreover, endogenous sex hormones, particularly estradiol, are well-documented to be cardioprotective in women without CKD; however, the role of sex hormones on vascular function in women with CKD remains unclear. The goals of the proposed project are: 1) to evaluate vasuclar function in pre- and post-menopausal women with CKD vs. age-matched healthy women; 2) to evaluate sex hormone concentrations and determine whether they associate with vascular function in the proposed cohort; and 3) to gain mechanistic insight on the association between sex hormones and vascular dysfunction in the proposed cohort.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pre- (18-44 y) and post-menopausal (55-75 y) women
- •Individuals with CKD including stage 3-4 (eGFR 15-59 ml/min/1.73m2) determined by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation AND/OR urinary albumin-creatinine ratio (UACR) ≥
- •Controls must be healthy (free from hypertension, kidney disease, cardiovascular disease, diabetes, and other chronic disease as assessed by self-report, medical history, and screening labs). Premenopausal healthy women must have a regular menstrual cycle (25-35 d).
排除标准
- •Perimenopausal (45-54 y) women
- •Pregnancy, lactation, or less than one year post-partum
- •Use of hormonal birth control methods, hormone replacement therapy, or a levonorgestrel intrauterine device (IUD) insertion for a duration less than 6 months
- •Advanced CKD requiring dialysis
- •History of kidney transplant
- •Use of immunosuppressant medications (unless taking a stable dosage for a quiescent disease in CKD group)
- •Antioxidant and/or omega-3 fatty acid use within the 2 weeks prior to testing
- •Current tobacco or nicotine use or history of use in the last 12 months
- •Marijuana use within 2 weeks prior to testing
- •Uncontrolled hypertension in CKD group (BP >140/90 mmHg)
- •Atrial fibrillation
- •Active infection or antibiotic therapy
- •Hospitalization in the last month
结局指标
主要结局
Brachial Artery Flow-Mediated Dilation
时间窗: Baseline
Flow-mediated dilation of the brachial artery will be performed using ultrasonography and analyzed with a commercially available software package as percent change in diameter from baseline following reactive hyperemia.
次要结局
- Serum Sex Hormones(Baseline)
- Carotid Femoral Pulse Wave Velocity(Baseline)
- Urinary Sex Hormones(Baseline)