PCOS
Conditions
Keywords
brain health, cerebral blood flow, polycystic ovarian syndrome, brain structure, cognition
Brief summary
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.
Detailed description
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.
Interventions
DEVICEMRI Visit
MRI visit will take approximately 1.5 hour (55-60 minutes in MRI) and will involve structural scans of the brain, and scans at rest and while performing cognitive tasks.
OTHERLaboratory Visit
DEXA scan for obtaining body composition, NIH toolbox to assess cognitive test, and optional graded exercise test (GXT).
Sponsors
University of Wisconsin, Madison
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
(Participants with PCOS): * Rotterdam criteria demonstrating two out of the three criteria. These are: 1. Presence of clinical hyperandrogenism or biochemical hyperandrogenism 2. A history of irregular menstrual cycles 3. 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cerebral Blood Flow (CBF) at rest | 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 | data collected during a 2-hour MRI visit (anytime up to 3 months on study) | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body composition via DEXA scan | data collected during a 2-hour lab visit (anytime up to 3 months on study) | Percent body fat and lean mass to be measured via Dual-Energy X-ray Absorptiometry (DEXA) scan. |
| NIH Toolbox: Dimensional Change Card Sort Test | data collected during a 2-hour lab visit (anytime up to 3 months on study) | NIH Toolbox to assess neurocognitive function. The Dimensional Change Card Sort Test measures accuracy: the number of accurate responses, up to a maximum of 40. |
| NIH Toolbox: Pattern Comparison Processing Speed Test | data collected during a 2-hour lab visit (anytime up to 3 months on study) | NIH Toolbox to assess neurocognitive function. The Pattern Comparison Processing Speed Test measures how many correct responses the participant has within 90 seconds. There is a maximum of 130 items. |
| NIH Toolbox: Flanker Inhibitory Control and Attention | data collected during a 2-hour lab visit (anytime up to 3 months on study) | NIH Toolbox to assess neurocognitive function. The Flanker test is a measure of executive function and is scored using a T-score where 100 is the average, higher scores indicate better performance. |
| Cardiorespiratory fitness (VO2max) [Optional] | data collected during a 2-hour lab visit (anytime up to 3 months on study) | — |
Countries
United States
Contacts
CONTACTSharon Blohowiak
PRINCIPAL_INVESTIGATORLaura Cooney, MD
University of Wisconsin, Madison
Outcome results
None listed