Comparison of Lifestyle Markers Between Women With & Without Polycystic

Status Completed

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01859663
Study type	Observational
Source	Cornell University
Contact
Status	Completed
Phase
Start date	May 2013
Completion date	May 2022

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT05661799` - Persistence of Physical Activity in People With Type 2 Diabetes Over Time.	N/A
Active, not recruiting	`NCT03903874` - Testing Scalable, IVR-supported Cancer Prevention Interventions in the Rural Alabama Black Belt	N/A
Recruiting	`NCT03662438` - HOPE (Home-based Oxygen [Portable] and Exercise) for Patients on Long Term Oxygen Therapy (LTOT)	N/A
Withdrawn	`NCT04540523` - Home-Based Exergaming Intervention	N/A
Recruiting	`NCT03250000` - Changes in Microcirculation and Functional Status During Exacerbation of COPD	N/A
Recruiting	`NCT05563805` - Exploring Virtual Reality Adventure Training Exergaming	N/A
Completed	`NCT03430648` - Is Tau Protein Linked to Mobility Function?
Completed	`NCT05019482` - Intervention Program Among University Student to Promote Physical Activity and Reduce the Sedentary Time	N/A
Completed	`NCT03253406` - Health Wearables and College Student Health	N/A
Not yet recruiting	`NCT05985460` - A Very Brief Intervention to Increase the Intention to Practice Physical Activity	N/A
Completed	`NCT03380143` - Whole-of-Community Youth Population Physical Activity	N/A
Completed	`NCT03700736` - The Healthy Moms Study: Comparison of a Post-Partum Weight Loss Intervention Delivered Via Facebook or In-Person Groups	N/A
Completed	`NCT03170921` - Psychophysiological Characterization of Different Capoeira Performances in Experienced Individuals	N/A
Completed	`NCT04973813` - Active Choice Intervention About Physical Activity for Physically Inactive Adults	N/A
Completed	`NCT03982095` - Survey on Lifestyle, Perceived Barriers and Development of Change in Patients With Prostate Cancer
Completed	`NCT03271112` - Frailty Prevention in Elders From Reunion Island	N/A
Completed	`NCT05670223` - Healthy Activities Improve Lives	N/A
Completed	`NCT04894929` - Comprehensive Geriatric Assessment in the Monitoring of Functional Improvement	N/A
Recruiting	`NCT04578067` - Empowering Immigrant Women for Active and Healthy Lifestyle	N/A
Completed	`NCT03297567` - Physical Therapy Guidelines For Hospitalized Elderly	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms