PCOS and Brain Health
ConditionPCOS
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-45
SponsorUniversity of Wisconsin, Madison
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Presence of clinical hyperandrogenism or biochemical hyperandrogenism
A history of irregular menstrual cycles
Presence of polycystic ovarian morphology on ultrasound
Regular menstrual cycles (not meeting criteria for irregular cycles above)
Disqualifiers
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
Trial population
Reproductive-aged individuals with ovaries, with and without PCOS
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
MRI Visit
DeviceMRI 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 Visit
Other interventionDEXA scan for obtaining body composition, NIH toolbox to assess cognitive test, and optional graded exercise test (GXT).
Treatment groups
45 Participants
are divided into 2 treatment groupsGroup A: Participants with PCOS2 interventions
Group B: Healthy Controls2 interventions
Trial outcomes
Primary outcomes
1
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)2
Circulating Sex Hormone Levels
Time frame
data collected during a 2-hour MRI visit (anytime up to 3 months on study)Secondary outcomes
1
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)2
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)3
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)4
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov