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临床试验/NCT05408273
NCT05408273已完成不适用

Vitamin D Effects on Microvascular Function and Cardiovascular Risk Factors on Postmenopausal Women

Rio de Janeiro State University1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2019年7月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
88
试验地点
1
主要终点
Vitamin D status and microvascular function

研究概览

简要总结

Many observational studies have demonstrated links between serum levels of 25-hydroxyvitamin D [25(OH)D] and cardiovascular risk (CVR) factors. Microvascular dysfunction relates not only to CVR but also to metabolic disease. Since cardiovascular disease (CVD) is the leading cause of death in postmenopausal women, it would be relevant to confirm this relationship. Maybe further studies would show that the correction of hypovitaminosis D could minimize the CVR. Our objective with this clinical trail is to analyze if vitamin D status is related to microvascular function and conventional cardiovascular risk (CVR) factors in postmenopausal women. For that we enrolled, in a pilot cross-sectional study, 39 non-smokers, low CVR postmenopausal women, with less than 10 years of hypoestrogenism and associations of 25(OH)D to adiposity, blood pressure, fasting aldosterone, insulin, glucose and lipid profile, HOMA-IR, parathormone and microvascular function, assessed by laser-Doppler flowmetry at cutaneous site, were investigated.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
45 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women between 45-60 years with clinical/laboratory criteria of menopause and duration of hypoestrogenism < 10 years. Menopause was spontaneous (at least one year of amenorrhea) or surgical (after bilateral oophorectomy). In hysterectomized women, ovarian failure was estimated by the history of vasomotor symptoms and serum levels of follicle-stimulating hormone (FSH) > 35 mU/mL and estradiol levels <20 pg/mL.

排除标准

  • Current smokers, body mass index (BMI) >35 kg/m², systolic BP >160 mmHg and or diastolic BP > 100 mmHg, total cholesterol >280 mg/dL, presence of T2D, renal dysfunction and or liver disease, clinical manifestations of coronary heart disease, and previous history of revascularization or cardiovascular event.

结局指标

主要结局

Vitamin D status and microvascular function

时间窗: 1 day

Vitamin D status and its relation to microvascular function and conventional cardiovascular risk (CVR) factors in postmenopausal women.

次要结局

未报告次要终点

研究者

发起方
Rio de Janeiro State University
申办方类型
Other
责任方
Principal Investigator
主要研究者

THAYSA FERNANDES LACERDA ROCHA COSTA

Principal Investigator on the Clinical and Experimental Pathophysiology Program

Rio de Janeiro State University

研究点 (1)

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