Functional and Structural Impacts of Polycystic Ovary Syndrome (PCOS) on Brain Health
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Cerebral Blood Flow (CBF) at rest
研究概览
简要总结
The purpose of this study is to determine how polycystic ovary syndrome (PCOS) impacts overall brain health, such as cerebral blood flow (CBF), brain structure and connectivity, and cognitive performance. 45 reproductive aged (18-45 years) individuals with ovaries, with and without PCOS, will be enrolled to complete brain structure and CBF scans via magnetic resonance imaging (MRI) over 2 testing visits and can expect to be on study for approximately 5 hours over a 1 to 3 month period.
详细描述
Aim 1: To determine whether individuals with PCOS exhibit reduced CBF at global, lobe and regional brain levels.
Aim 2: To assess whether individuals with PCOS have alterations in brain structure including grey and white volume, cortical thickness, or connectivity compared to controls.
Aim 3: To evaluate whether individuals with PCOS demonstrate impairments in cognitive performance, including verbal fluency, memory, and processing speed, relative to controls.
Aim 4: To characterize systemic immune cell states, circulating inflammatory and metabolic profiles, and epigenomic regulatory landscapes in peripheral blood of individuals with and without PCOS, and to evaluate whether these multiomic signatures are associated with CBF, brain structure, connectivity, and cognitive performance.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •(Participants with PCOS):
- •Rotterdam criteria demonstrating two out of the three criteria. These are:
- •Presence of clinical hyperandrogenism or biochemical hyperandrogenism
- •A history of irregular menstrual cycles
- •Presence of polycystic ovarian morphology on ultrasound
- •Inclusion Criteria (Healthy Controls):
- •Regular menstrual cycles (not meeting criteria for irregular cycles above)
- •No diagnosis of PCOS
- •Controls may have isolated hirsutism or polycystic ovaries on ultrasound as long as they do not meet Rotterdam criteria for PCOS
排除标准
- •Current pregnancy
- •Preexisting diagnosis of type 1 diabetes
- •Severe obesity (body mass index (BMI) greater than 45kg/m2)
- •Preexisting diagnosis of hypertension requiring antihypertensive medication or blood pressure of greater than 160/100 on two separate occasions during clinical care
- •History of neurologic disease or stroke
- •History of myocardial infarction or deep venous thrombosis
- •Endometriosis confirmed by prior laparoscopy
- •Autoimmune conditions including lupus, multiple sclerosis, and active malignancy
- •Immuno-modulating medications
- •Conditions incompatible with MRI scanning, including but not limited to
- •Certain implanted metal devices or foreign bodies
- •Severe claustrophobia
- •Post-menopausal
- •Participants will be excluded if they have taken hormonal contraception or fertility medication in the last month
研究组 & 干预措施
Participants with PCOS
N=30 participants recruited
干预措施: MRI Visit (Device)
Participants with PCOS
N=30 participants recruited
干预措施: Laboratory Visit (Other)
Healthy Controls
N=15 age and BMI-matched participants recruited
干预措施: MRI Visit (Device)
Healthy Controls
N=15 age and BMI-matched participants recruited
干预措施: Laboratory Visit (Other)
结局指标
主要结局
Cerebral Blood Flow (CBF) at rest
时间窗: data collected during a 2-hour MRI visit (anytime up to 3 months on study)
Arterial Spin Labeling (ASL) color atlases and 4D Flow MRI will be used to measure CBF at rest. CBF will be measured in each of six brain regions: temporal, parietal, frontal, occipital, subcortical, and brainstem.
Circulating Sex Hormone Levels
时间窗: data collected during a 2-hour MRI visit (anytime up to 3 months on study)
次要结局
- Body composition via DEXA scan(data collected during a 2-hour lab visit (anytime up to 3 months on study))
- NIH Toolbox: Dimensional Change Card Sort Test(data collected during a 2-hour lab visit (anytime up to 3 months on study))
- NIH Toolbox: Pattern Comparison Processing Speed Test(data collected during a 2-hour lab visit (anytime up to 3 months on study))
- NIH Toolbox: Flanker Inhibitory Control and Attention(data collected during a 2-hour lab visit (anytime up to 3 months on study))
- Cardiorespiratory fitness (VO2max) [Optional](data collected during a 2-hour lab visit (anytime up to 3 months on study))