Chronic Effects of Estrogen in Microcirculation and Insulin Resistance in Postmenopausal Obese Women
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- functional capillary density by videocapillaroscopy(number of perfused capillaries on the studied skin area)
研究概览
简要总结
This study aims to evaluate the chronic effects of estrogen on microcirculation, inflammatory biomarkers, hormonal status, plasma viscosity and biochemical tests in postmenopausal obese women after three months of follow-up intervention.
详细描述
Estrogens exert pleiotropic actions on the cardiovascular system through binding to estrogen receptors. Traditionally, estrogen receptors have been recognized as transcription factors regulating the expression of target genes, however, numerous studies have revealed rapid actions of estrogen in different systems, so-called 'extranuclear actions'. At this level, estrogen triggers rapid vasodilatation, exerts anti-inflammatory effects, regulates vascular cell growth and migration, and confers protection to cardiomyocytes. Our aims are to investigate estrogen´s chronic effects on microcirculation.
The study will assess the potential benefits of estrogens on: chronic low-grade inflammation, metabolic profile, microcirculation and blood rheology. Postmenopausal obese women will be randomly submitted to estrogen (transdermal 17-β-estradiol 1mg/day) or placebo therapy during three months in a double-blind fashion. At baseline and after intervention, nailfold videocapillaroscopy, laser-Doppler flowmetry and venous occlusion plethysmography, inflammatory biomarkers, hormonal status, metabolic profile, plasma viscosity and anthropometrical measures will be assessed in all subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 48 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •History of natural menopause defined by the absence of menses for at least 12 months and a serum concentration of FSH > 35 IU/L
- •BMI between 27 to 34.9 kg/m²
- •Non-smokers
- •Not on use of any hormones or supplements for a minimum of 6 months prior to the study
- •No absolute contraindications to the use of physiological replacement doses of estrogen
排除标准
- •Renal disease, coronary or peripheral vascular diseases, haematologic or hepatic diseases
- •Diabetes mellitus, glucose intolerance or altered fasting glucose
研究组 & 干预措施
placebo
placebo (transdermal gel)
干预措施: Estrogen (Drug)
Estrogen
1mg of 17B-estradiol/day (transdermal gel)
干预措施: Estrogen (Drug)
结局指标
主要结局
functional capillary density by videocapillaroscopy(number of perfused capillaries on the studied skin area)
时间窗: 03 months
次要结局
- blood viscosity(the values are expressed in centipoises)(03 months)
研究者
Luiz Guilherme Kraemer de Aguiar
Chronic Effects of Estrogen in Microcirculation and Insulin Resistance in Postmenopausal Obese Women
Rio de Janeiro State University