Comparison of Lifestyle Markers Between Women With and Without Polycystic Ovary Syndrome

Physical Activity Clinical Trial

Official title:

Baseline Assessment of Dietary Intake and Physical Activity in Women With Polycystic Ovary Syndrome (PCOS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01859663
• Other study ID #: IRB 1303003665
• Status: Completed
• Start date: May 2013
• Est. completion date: May 2022

Study information

• Verified date: February 2024
• Source: Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of the study is to identify lifestyle factors associated with PCOS and understand how diet and activity levels impact features of PCOS. The secondary aim is to examine psychosocial factors (e.g., health beliefs) of women with PCOS.

Description:

Polycystic ovary syndrome (PCOS) is an endocrine disorder that affects 6-12% of reproductive-aged women within the general population. Currently, there is limited knowledge on the current lifestyles of women with PCOS and the psychosocial factors associated with PCOS.

The researchers plan to examine potential lifestyle differences and psychosocial factors between PCOS and healthy women. The Research Team is also interested in the relationships between biological markers and lifestyle endpoints in women with and without PCOS. Previous literature has shown there are biological marker differences between those with and without PCOS. By examining these relationships, researchers may further understand whether PCOS status is associated with lifestyle parameters.

To accomplish these objectives, 360 women (120 women with PCOS, 120 women without PCOS and with normal menstrual cycles, and 120 women without PCOS and with irregular menstrual cycles) will be included in this study. An equal number of lean and overweight/obese women will be recruited within each group based on body mass index (BMI; Lean = 18 - 24 kg/m2 and overweight/obese ≥ 25 kg/m2). Women will be included in the PCOS group if they have a confirmed PCOS diagnosis from their primary care provider. Participants will complete a food frequency questionnaire, a sleep questionnaire, and a physical activity questionnaire. A researcher may also provide participants with a waist-worn accelerometer to monitor physical activity and a wrist-worn accelerometer to monitor sleep for a week. Ultrasound scans of the ovaries will be assessed and the following metabolic parameters will be assessed: (1) 75-gram oral glucose tolerance test; (2) dual X-ray absorptiometry (DXA) scan; (3) vitals and anthropometry assessment to measure waist and hip circumference, height, weight, blood pressure, and heart rate; (4) fasting blood tests to detect androgens (i.e., total testosterone, androstenedione, free androgen index); and (5) an (optional) subcutaneous fat biopsy. Women with and without PCOS will also be asked to complete a questionnaire that will assess the psychosocial factors (e.g., health beliefs). This can be conducted online, in person, or through phone.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: May 2022
• Est. primary completion date: May 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 48 Years

Eligibility

Inclusion Criteria:

• Between 18 and 48 years

• BMI = 18 kg/m2

• If = 21 years old, must have completed a pelvic exam in the past 2 years

• In PCOS if: Confirmed PCOS diagnosis from their primary care provider

Exclusion Criteria:

• Use of oral contraceptives, fertility medications, or any drugs known to influence reproductive function

• Pregnant or breastfeeding

Related Conditions & MeSH terms

• Dietary Habits
• Physical Activity
• Polycystic Ovary Syndrome
• Syndrome

Locations

Country	Name	City	State
United States	Human Metabolic Research Unit, Cornell University	Ithaca	New York
United States	CRC at University of Rochester Medical Center	Rochester	New York
United States	Strong Fertility Center	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
Cornell University	University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in diet between women with and without PCOS	A food frequency questionnaire will be administered to assess diet composition for the last three months.	1 week
Secondary	Differences in exercise between women with and without PCOS	An accelerometer will be administered to assess physical activity for 1 week.	1 week
Secondary	Differences in psychosocial factors (e.g., health beliefs) of women with and without PCOS	A questionnaire will be administered to assess psychosocial factors of women with PCOS.	1-2 weeks
Secondary	Differences in sleep patterns between women with and without PCOS	A wrist-worn accelerometer will be administered to assess sleep patterns for 6 consecutive nights.	6 consecutive nights
Secondary	LH-FSH ratio	The ratio of circulating LH to FSH concentrations in the serum will be determined for each participant and compared across groups	1 day
Secondary	Hirsutism Score	Degree of hirsutism as judged by the Ferriman-Gallwey scale will be determined and compared across groups; Degree of hirsutism as judged by the Ferriman-Gallwey scale will be determined and compared across groups	1 day
Secondary	Androgen concentrations	Total testosterone, androstenedione and free androgen index concentrations in serum will be determined and compared across groups.	1 day
Secondary	Menstrual Cycle Length	Average menstrual cycle length as determined by self-reported history will be determined and compared across groups	1 day
Secondary	Body Mass Index	The ratio of weight to height will be determined and compared across groups.	1 day
Secondary	Waist-to-Hip Ratio	The ratio of waist circumference to hip circumference will be determined and compared across groups	1 day
Secondary	Ovarian Volume	The size of each ovary will be determined using ultrasonography for each participant during study participation and compared between groups.	1 day
Secondary	Insulin Sensitivity	Insulin sensitivity will be determined by administration of an oral glucose tolerance test and compared between groups.	1 day
Secondary	Serum progesterone concentration	The serum progesterone concentration will be determined during study participation, assessed in association with luteal dynamics and compared between groups.	1 day
Secondary	Blood pressure	Blood pressure will be determined and compared between groups.	1 day
Secondary	Serum markers of metabolic syndrome	Lipids, glucose and HbA1C concentrations will be determined and compared between groups.	1 day
Secondary	Body fat distribution	Percentage and distribution of fat and lean mass as assessed using DXA technology will be compared between groups.	1 day
Secondary	Subcutaneous fat biopsy (optional)	Subcutaneous fat cells, which represent important sites of reproductive hormone synthesis, will be assessed and compared across groups	1 day