PCOS and Brain Health

University of Wisconsin, Madison45 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

PCOS

Interventions

MRI VisitDEVICE

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.

Laboratory VisitOTHER

DEXA scan for obtaining body composition, NIH toolbox to assess cognitive test, and optional graded exercise test (GXT).

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Wisconsin

Madison, Wisconsin, United States

RECRUITING

Outcomes

Primary Outcomes

Cerebral Blood Flow (CBF) at rest

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.

Time frame: data collected during a 2-hour MRI visit (anytime up to 3 months on study)

Circulating Sex Hormone Levels

Time frame: data collected during a 2-hour MRI visit (anytime up to 3 months on study)

Secondary Outcomes

Body composition via DEXA scan

Percent body fat and lean mass to be measured via Dual-Energy X-ray Absorptiometry (DEXA) scan.

Time frame: data collected during a 2-hour lab visit (anytime up to 3 months on study)

NIH Toolbox: Dimensional Change Card Sort Test

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.

Time frame: data collected during a 2-hour lab visit (anytime up to 3 months on study)

NIH Toolbox: Pattern Comparison Processing Speed Test

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.

Time frame: data collected during a 2-hour lab visit (anytime up to 3 months on study)

NIH Toolbox: Flanker Inhibitory Control and Attention

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.

Time frame: data collected during a 2-hour lab visit (anytime up to 3 months on study)

Central Contacts

Sharon Blohowiak

CONTACT

(608) 262-5977 sblohowiak@wisc.edu

Data from ClinicalTrials.gov

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