Clinical trial NCT05769426: Health Risks and Barriers to Management Across the PCOS Lifespan
Official title: Health Risks and Barriers to Management Across the PCOS Lifespan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polycystic Ovary Syndrome
Menopause
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
First posted: 2023-03-15
Enrollment: 49
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Community sample

Brief summary: The overall objective of the proposed pilot project is to explore health literacy and barriers to management of PCOS across the lifespan and determine whether the cardiometabolic risks of PCOS extend beyond menopause. The investigators hypothesize that barriers to PCOS management exist and cardiometabolic risks for this population are magnified by aging and menopause.

Detailed description: This proposed research serves to provide preliminary data to determine how the metabolic consequences of menopause are exacerbated in women with PCOS. In addition, the investigators will identify barriers to lifestyle management strategies for women with PCOS across the lifespan. The findings will provide preliminary data to inform future interventions to reduce cardiometabolic risk among postmenopausal women with PCOS. Understanding literacy skills and barriers to PCOS management will facilitate the development of personalized, therapeutic strategies and clear communication between patient-health care provider. Furthermore, these practices will help women with PCOS become more involved in their health care decisions and improve women's health.

Therefore, our specific aims are twofold:

Aim 1. Explore and contrast health literacy and barriers to lifestyle management among reproductive-aged and postmenopausal women with PCOS. Using semi-structured, qualitative interviews and REDCap surveys, the investigators will assess differences in health literacy, self-efficacy, and barriers to lifestyle management practices in groups of women with PCOS who are of reproductive age or post-menopausal.

Aim 2. Assess and compare the metabolic risk of women with PCOS to age and BMI-matched, postmenopausal controls. The cohort of post-menopausal women with PCOS in Aim 1 and a cohort of age and BMI-matched post-menopausal women who have no history of hyperandrogenism/PCOS will complete measurement of cardiometabolic risk factors, androgen profile and body composition via dual energy x-ray absorptiometry.

Eligibility criteria: Inclusion Criteria:

* All races and ethnicities
* Females who are of reproductive age (18-40 years) \[PCOS-PRE only\]
* Females who are (≥ 50 years) and post-menopausal (no menstruation within the last 12 months) \[PCOS-POST and CON-POST only\]
* Score of 3 or more on Self-administered screener to screen for PCOS and/or diagnosis of PCOS (ICD-10 code E28.2 or other) \[PCOS-PRE and PCOS-POST only\]
* Score of 0-2 on Self-administered screener to screen for PCOS and no self-reported history of PCOS or hyperandrogenism \[CON-POST only\]
* Access to an electronic device that have virtual/video capabilities \[PCOS-PRE and PCOS-POST only\]
* BMI 18.5-40 kg/m2
* Able to read and speak English

Exclusion Criteria:

* Current smoker
* Alcohol abuse
* Currently pregnant or lactating
* Recent (within 3 years) diagnosis/treatment of cancer (excluding basal cell carcinoma)
* Hormone replacement therapy use within the last 3 months
* Surgical menopause (Oophorectomy or other surgical cause of menopause)
* Prisoner/TDCJ
* Any other condition or event considered exclusionary by study PIs

Primary outcomes:
measure: Qualitative Interview
timeFrame: Baseline
measure: PROMIS Physical Function (10a)
timeFrame: Baseline
measure: PROMIS Fatigue
timeFrame: Baseline
measure: PROMIS Sleep Disturbance
timeFrame: Baseline
measure: PROMIS Sleep-related Impairment
timeFrame: Baseline
measure: PROMIS Depression
timeFrame: Baseline
measure: PROMIS Anxiety
timeFrame: Baseline
measure: PROMIS Satisfaction with roles and abilities
timeFrame: Baseline
measure: PROMIS Ability to participate in social roles and activity
timeFrame: Baseline
measure: Exercise Self-Efficacy Scale
timeFrame: Baseline
measure: Eating at America's Table Study survey
timeFrame: Baseline
measure: Height
timeFrame: Baseline
measure: Weight
timeFrame: Baseline
measure: Whole body lean mass
timeFrame: Baseline
measure: Appendicular lean mass
timeFrame: Baseline
measure: Total fat mass
timeFrame: Baseline
measure: Visceral fat mass
timeFrame: Baseline
measure: Total cholesterol
timeFrame: Baseline
measure: LDL cholesterol
timeFrame: Baseline
measure: HDL cholesterol
timeFrame: Baseline
measure: Triglycerides
timeFrame: Baseline
measure: Glucose
timeFrame: Baseline
measure: Insulin
timeFrame: Baseline
measure: Hemoglobin A1C
timeFrame: Baseline
measure: Estradiol
timeFrame: Baseline
measure: Testosterone
timeFrame: Baseline
measure: Androstenedione
timeFrame: Baseline
measure: Sex hormone binding globulin
timeFrame: Baseline
measure: Systolic blood pressure
timeFrame: Baseline
measure: Diastolic blood pressure
timeFrame: Baseline
measure: Waist Circumference
timeFrame: Baseline
measure: Hip Circumference
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
measure: Clot stability
timeFrame: Baseline
measure: Platelet function
timeFrame: Baseline
Locations:
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
Study officials:
affiliation: University of Texas
name: Emily Lantz, PhD
role: PRINCIPAL_INVESTIGATOR
References: