Vascular Disease, Inflammation and Hormones in Women With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Flow-mediated dilation (FMD) at follow-up
研究概览
简要总结
This study planned to learn more about women and how the drop in estradiol levels during menopause may affect their cardiovascular risk. With aging, the arteries that are located around the heart get stiffer, and this increase in arterial stiffness can lead to a number of health problems such as high blood pressure and heart disease. In this study, the investigators examined whether a short-term drop in estrogen levels caused arteries to become stiffer, and explored potential reasons for stiffening arteries.
详细描述
Participants completed two study visits. The baseline study visit occurred during the early follicular phase of the menstrual cycle, confirmed via take-home ovulation testing. On the day of the baseline study visit, all participants underwent ovarian sex hormone suppression with GnRHant therapy (cetrorelix acetate, 0.25 mg/day) delivered daily as subcutaneous injections for a 1-week period. Participants were randomized to one of two concurrent intervention groups: transdermal estradiol patch (0.075 mg/day) (+E2) or placebo patch (+PL) and returned for a follow-up visit after 1 week of the intervention. Both study visits included collection of anthropometric measures, a fasting blood sample, measures of arterial stiffness, flow-mediated dilation, and endothelial cells via an intravenous catheter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Premenopausal
- •Euthyroid
- •Not currently planning to become pregnant
- •Not currently breastfeeding
- •No recent history of amenorrhea in the previous 6 months
- •Consent to data and specimen banking
- •No use of hormonal contraceptives
- •Inclusion Criteria, type 1 diabetes only:
- •Diagnosis of type 1 diabetes for at least 5 years
- •On insulin within a year of diagnosis
- •Current insulin therapy
- •Hemoglobin A1c < 9.5%
- •No macroalbuminuria (AER < 200 ug/min)
- •Inclusion Criteria, non-diabetic controls only:
- •Hemoglobin A1c < 5.7%
排除标准
- •Pregnant and/or breastfeeding
- •Have not had a menstrual cycle in the last 6 months
研究组 & 干预措施
GnRHant + E2
Participants in this arm received GnRHant and a transdermal estradiol patch (0.075 mg/day) for a period of 1 week.
干预措施: Cetrorelix acetate, 0.25 mg/day (Drug)
GnRHant + E2
Participants in this arm received GnRHant and a transdermal estradiol patch (0.075 mg/day) for a period of 1 week.
干预措施: Estradiol Patch, 0.025 Mg/24 Hours Weekly Transdermal Film, Extended Release (Drug)
GnRHant + PL
Participants in this arm received GnRHant and a placebo patch for a period of 1 week.
干预措施: Cetrorelix acetate, 0.25 mg/day (Drug)
GnRHant + PL
Participants in this arm received GnRHant and a placebo patch for a period of 1 week.
干预措施: Placebo patch (Drug)
结局指标
主要结局
Flow-mediated dilation (FMD) at follow-up
时间窗: 1 week
FMD will be measured following an intravenous saline infusion and ascorbic acid infusion.
Quantitative immunuofluorescence of endothelial cell proteins at baseline
时间窗: Baseline
Expression of estrogen receptor alpha, estrogen receptor beta, endothelial nitric oxide synthase, and phosphorylated endothelial nitric oxide synthase in endothelial cells
Quantitative immunuofluorescence of endothelial cell proteins at follow-up
时间窗: 1 week
Expression of estrogen receptor alpha, estrogen receptor beta, endothelial nitric oxide synthase, and phosphorylated endothelial nitric oxide synthase in endothelial cells
Flow-mediated dilation (FMD) at baseline
时间窗: 1 week
FMD will be measured following an intravenous saline infusion and ascorbic acid infusion.
Change in flow-mediated dilation (FMD)
时间窗: Baseline and 1 week
FMD will be measured following an intravenous saline infusion and ascorbic acid infusion at baseline and follow-up.
Change in quantitative immunuofluorescence of endothelial cell proteins
时间窗: Baseline and 1 week
Expression of estrogen receptor alpha, estrogen receptor beta, endothelial nitric oxide synthase, and phosphorylated endothelial nitric oxide synthase in endothelial cells
次要结局
未报告次要终点