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

NCT ID: NCT01859663

Last Updated: 2024-02-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 126 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2022-05-31

Brief 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.

Detailed 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.

Conditions

Polycystic Ovary Syndrome; Dietary Habits; Physical Activity

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

Women with a past diagnosis of PCOS

We aim to recruit 120 women with a past diagnosis of PCOS. An equal number of lean and overweight/obese women will be recruited within this group based on body mass index (BMI; Lean = 18 - 24 kg/m2 and overweight/obese ≥ 25 kg/m2).

No interventions assigned to this group

Women with a history of regular menstrual cycles

We aim to recruit 120 women with a history of regular menstrual cycles. An equal number of lean and overweight/obese women will be recruited within this group based on body mass index (BMI; Lean = 18 - 24 kg/m2 and overweight/obese ≥ 25 kg/m2).

No interventions assigned to this group

Women with a history of irregular menstrual cycles

We aim to recruit 120 women with a history of irregular menstrual cycles, and no previous diagnosis of PCOS. An equal number of lean and overweight/obese women will be recruited within this group based on body mass index (BMI; Lean = 18 - 24 kg/m2 and overweight/obese ≥ 25 kg/m2).

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 48 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Rochester

OTHER

Sponsor Role: collaborator

Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marla E. Lujan, PhD

Role: PRINCIPAL_INVESTIGATOR

Cornell University

Locations

Human Metabolic Research Unit, Cornell University

Ithaca, New York, United States

Strong Fertility Center

Rochester, New York, United States

CRC at University of Rochester Medical Center

Rochester, New York, United States

Countries

United States

References

Lin AW, Dollahite JS, Sobal J, Lujan ME. Health-related knowledge, beliefs and self-efficacy in women with polycystic ovary syndrome. Hum Reprod. 2018 Jan 1;33(1):91-100. doi: 10.1093/humrep/dex351.

Reference Type: DERIVED

PMID: 29182737 (View on PubMed)

Other Identifiers

IRB 1303003665

Identifier Type: -

Identifier Source: org_study_id