Vascular Function and Uterine Fibroids
关键词
抽象
描述
The investigators are inviting women, 25-50 years old, who have not gone through menopause to participate in this study. The investigators are looking for some women with uterine fibroids and some without uterine fibroids based on ultrasound or MRI. If the patients have not had a recent ultrasound or MRI of the uterus, a physician can provide one.
Individuals cannot participate if they have high blood pressure, diabetes, or disease in the kidneys, lungs, or blood vessels. Also, individuals who smoke, have high cholesterol, or are obese (BMI is higher than 30) cannot participate. Certain medications, including high blood pressure medications, beta-blockers and anti-depressants, will also limit potential patient participation. The investigators would be happy to review medications for potential participants.
Screen Day:
One of the members of the research team will review the study and the informed consent document with the patient. The patient will have their height, weight, blood pressure, pulse and respirations measured. The patient will also complete three questionnaires. If the patient has not had an ultrasound of the uterus in the last 12 months, a physician will complete one for her.
Study Day:
The patient will need to fast overnight (no eating or drinking). The investigators will draw a blood sample and then do a series of tests on the participant's blood vessels. For some of the tests, medication will be given through an IV. The investigators will also test nerve activity in the nerve on the outer aspect of the leg.
日期
| 最后验证: | 02/28/2018 |
| 首次提交: | 04/15/2014 |
| 提交的预估入学人数: | 04/23/2014 |
| 首次发布: | 04/24/2014 |
| 上次提交的更新: | 02/28/2018 |
| 最近更新发布: | 03/01/2018 |
| 实际学习开始日期: | 03/31/2013 |
| 预计主要完成日期: | 02/28/2018 |
| 预计完成日期: | 02/28/2018 |
状况或疾病
干预/治疗
Device: Brachial artery catheter
Drug: Acetylcholine
Drug: Nitroprusside
Drug: Norepinephrine
Drug: Nitroprusside and phenylephrine
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Women with uterine fibroids Brachial artery catheter
Acetylcholine
Nitroprusside
Norepinephrine
Nitroprusside and phenylephrine | |
| Women without uterine fibroids Brachial artery catheter
Acetylcholine
Nitroprusside
Norepinephrine
Nitroprusside and phenylephrine |
资格标准
| 有资格学习的年龄 | 25 Years 至 25 Years |
| 有资格学习的性别 | Female |
| 取样方式 | Non-Probability Sample |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - Women 25-50 years old - Premenopausal Exclusion Criteria: - Postmenopausal - Pregnant or currently breastfeeding - Using blood pressure medications or anti-depression medications - High blood pressure - Diabetes - Disease in the kidneys, lungs, or blood vessels - Chronic diseases (for example: Crohn's disease, rheumatoid arthritis, bipolar mood disorder, etc.) - Smoker - High cholesterol - BMI higher than 30 |
结果
主要结果指标
1. Baseline systolic, diastolic, and mean blood pressures [One day (study day)]
2. Baseline sympathetic nerve activity [One day (study day)]
次要成果指标
1. Changes in forearm blood flow levels in response to acetylcholine infusion [One day (study day)]
2. Changes in forearm blood flow levels in response to nitroprusside infusion [One day (study day)]
3. Changes in forearm blood flow levels in response to norepinephrine infusion [One day (study day)]
4. Change in blood pressure in response to infusions of nitroprusside and phenylephrine [One day (study)]
5. Pulse wave velocity (an index of vessel stiffness) [One day (study day)]
其他成果措施
1. Female sex hormone levels [One day (study day)]
