Effects of Continuous Estrogen on Human in Vivo Microvascular Function
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Change in blood vessel dilation
研究概览
简要总结
The goal of this study is to learn how long-term use of estrogen affects blood vessels in healthy adults.
Participants will:
- give one blood draw of 5 mL
- have one Dexa Scan taken to measure adipose and muscle mass
- have a camera placed under the tongue to take pictures of blood vessels
- have 2 laser Doppler microdialysis catheters placed on the forearm to monitor blood vessels before and after local drug infusion
Researchers will compare blood vessel function of those who take estrogen to those who do not.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Estrogen/Progestin Group
- •Adults aged 18-40 years
- •Females with estrogen/progestin treatment for a minimum of 1 year.
- •Blood pressure <140/ < 90 mmHg
- •No more than 1 cardiovascular risk factor Control Groups
- •Adults aged 18-40 years
- •Female with no estrogen/progestin treatment for minimum of 5 years.
- •Female undergoing progestin only treatment for a minimum of 1 year.
- •Blood pressure <140/ < 90 mmHg
- •No more than 1 cardiovascular risk factor
排除标准
- •Medications that could alter cardiovascular control
- •Rash, skin disease, or pigmentation disorders on both forearms
- •Kidney Disease
- •Known skin allergies
- •Smoking or tobacco use within last 6 months
- •Coronary Artery Disease
- •1 cardiovascular risk factor Hypertension Diabetes Hypercholesterolemia Hyperlipidemia
- •Bleeding disorders
- •Use of anti-coagulants
- •Allergies to study drugs
- •Use of topical/non-topical steroids in last 6 months
- •Internal mouth sores
- •Forearms covered with tattoos
- •Pregnancy
研究组 & 干预措施
Continuous estrogen/progestin
Females who have had continuous estrogen/progestin treatment for a minimum of 1 year.
干预措施: Nω-nitro-L-arginine methyl ester (L-NAME) (Drug)
No Estrogen/progestin
Females who have not had continuous estrogen treatment for a minimum of 5 years.
干预措施: Nω-nitro-L-arginine methyl ester (L-NAME) (Drug)
Continuous progestin
Females who have had continuous progestin treatment for a minimum of 1 year.
干预措施: Nω-nitro-L-arginine methyl ester (L-NAME) (Drug)
No Estrogen/progestin
Females who have not had continuous estrogen treatment for a minimum of 5 years.
干预措施: Acetylcholine (Drug)
No Estrogen/progestin
Females who have not had continuous estrogen treatment for a minimum of 5 years.
干预措施: Sodium Nitroprusside (Drug)
Continuous estrogen/progestin
Females who have had continuous estrogen/progestin treatment for a minimum of 1 year.
干预措施: Acetylcholine (Drug)
Continuous progestin
Females who have had continuous progestin treatment for a minimum of 1 year.
干预措施: Acetylcholine (Drug)
Continuous progestin
Females who have had continuous progestin treatment for a minimum of 1 year.
干预措施: Sodium Nitroprusside (Drug)
Continuous estrogen/progestin
Females who have had continuous estrogen/progestin treatment for a minimum of 1 year.
干预措施: Sodium Nitroprusside (Drug)
结局指标
主要结局
Change in blood vessel dilation
时间窗: 2 hours
Cutaneous vascular conductance in response to acetylcholine, L-NAME, and sodium nitroprusside infusions will be calculated as percentage of cardiovascular conductance.
Change in Perfused Vessel Density
时间窗: 0.5 hours
Total vessel density (TVD) will be calculated using the DeBacker Score manual analysis on all images that have a minimum microcirculation image quality score (MIQS) of 10. Perfused vessel density (PVD) will be calculated by multiplying total vessel density (TVD) x proportion of perfused vessels (PPV%).
次要结局
未报告次要终点
研究者
Julie K. Freed
Associate Professor
Medical College of Wisconsin