Hypothalamic Amenorrhea as a Fertility Status Marker for Cardiovascular Health
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Mayo Clinic
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Vascular inflammation
研究概览
简要总结
Hypothalamic amenorrhea (HA) occurs during reproductive years and results in stopped menstrual cycles and infertility which can be prolonged from months to years and is characterized by varying combinations of psychosocial stress, anxiety, high levels of physical activity, and/or weight loss. Data from our group indicates that one-third of women with HA (mean age: 27 yrs) have preclinical cardiovascular disease (CVD) measured noninvasively as vascular dysfunction and vascular inflammation. This study will use HA as a marker of fertility status for cardiovascular health and perform dense-phenotyping using remote patient monitoring (FitBit) and patient reported outcomes (questionnaires) to determine which HA phenotypes are related to preclinical CVD and inflammation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Secondary amenorrhea of 3 or more consecutive months duration
- •Include the screening hormones (eg, estradiol (E2) < 50 pg/ml, Follicle-Stimulating Hormone (FSH) <10 mIU/ml, and Luteinizing Hormone (LH) < 10mIU/ml and other HA-defining hormones); or clinical diagnosis of HA by medical providers.
- •Pre-menopause status.
- •Able to give informed consent.
排除标准
- •A diagnosis for secondary amenorrhea including prolactinoma, Polycystic Ovary Syndrome (PCOS), premature ovarian insufficiency, pituitary surgery, infection or infarction
- •Pregnancy
- •Psychotropic/illicit drug use
- •Mental/neurological/major psychological disorders (other than depression and anxiety).
- •Parturition/lactating in the last 6-12 months.
结局指标
主要结局
Vascular inflammation
时间窗: 3 months
concentration of cytokines multiplex immunoassay platform
Vascular dysfunction
时间窗: 3 months
Measured by reactive hyperemic index (RHI)
Psychosocial stress
时间窗: 3 months
Measured by NIH PROMIS® short-form questionnaires
Step count
时间窗: 3 months
Measured by Fitbit Versa 2 watch that tracks steps per day, active and resting heart rate, sleep hours per day
Physical activity level
时间窗: 3 months
Measured by Fitbit Versa 2 watch that tracks amount of light physical activity, moderate, and vigorous activity
Hypothalamic Amenorrhea (HA) duration
时间窗: 3 months
Duration of HA by month of amenorrhea (absence of menstruation)
Caloric intake and nutrition
时间窗: 3 days
Measured using a self-reported food diary
Heart Rate
时间窗: 3 months
Measured by Fitbit Versa 2 watch that tracks heart rate
Perceived stress
时间窗: 3 months
Measured by the validate perceived stress scale questionnaire, a 10-item questionnaire, scores range from 0 to 40; higher scores indicate higher levels of perceived stress.
次要结局
未报告次要终点
研究者
Chrisandra L. Shufelt, MD
Principal Investigator
Mayo Clinic