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| ID | Type | Description | Link |
|---|---|---|---|
| R01HD106096 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Hypothalamic Amenorrhea (HA) duration | Duration of HA by month of amenorrhea (absence of menstruation) | 3 months |
| Vascular dysfunction | Measured by reactive hyperemic index (RHI) | 3 months |
| Psychosocial stress | Measured by NIH PROMIS® short-form questionnaires | 3 months |
| Perceived stress | 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. | 3 months |
| Step count | Measured by Fitbit Versa 2 watch that tracks steps per day, active and resting heart rate, sleep hours per day | 3 months |
| Physical activity level | Measured by Fitbit Versa 2 watch that tracks amount of light physical activity, moderate, and vigorous activity | 3 months |
| Heart Rate | Measured by Fitbit Versa 2 watch that tracks heart rate | 3 months |
| Caloric intake and nutrition | Measured using a self-reported food diary |
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Inclusion Criteria:
Exclusion Criteria:
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Premenopausal women with hypothalamic amenorrhea at Mayo Clinic Florida.
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| Name | Affiliation | Role |
|---|---|---|
| Chrisandra Shufelt, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Florida | Jacksonville | Florida | 32224 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D000568 | Amenorrhea |
| ID | Term |
|---|---|
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 3 days |
| Vascular inflammation | concentration of cytokines multiplex immunoassay platform | 3 months |