Glucose Metabolism and Quality of Life in Healthy Women (Healthywomen)
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|ClinicalTrials.gov Identifier: NCT01995773|
Recruitment Status : Completed
First Posted : November 27, 2013
Last Update Posted : August 23, 2018
Polycystic ovary syndrome (PCOS) is a common endocrine disorder in premenopausal women. Women with PCOS often have problems with fertility, unwanted hair growth, and irregular menstrual cycle. PCOS is associated with obesity, changes in glucose metabolism and low quality of life.
In the present study, hormonal profile, glucose metabolism, adrenal functon, androgen levels, cortisol metabolism, anflammatory response, ovarian morphology, body composition, pfysical activity and quality of life is studied in 40 healthy women. The results will be compared with results from studies on women with PCOS in order to investigate any differences in these parametres.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||40 participants|
|Official Title:||Glucose Metabolism, Adrenal Function, Cortisol Metabolism, Body Composition Physical Activity, and Quality of Life in Healthy Women|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||June 2013|
Healthy control women
- Level of androgens [ Time Frame: baseline ]Level of testosterone and sexual hormone binding globuline in blood samples
- Quality of life [ Time Frame: Baseline ]Quality of life measured by validated questionnaires
- Body composition [ Time Frame: baseline ]Body composition measured by full body DXA-scan with estimates on lean body mass and fat mass
- Bone density [ Time Frame: baseline ]Bone density measured by DXA scan of hip and wrist
- Glucose tolerance [ Time Frame: 5 hours ]Glucose tolerance measured by 5 hour oral glucose tolerance test with blood glucose measurements for 5 hours after oral intake of 75 g glucose
- physical activity [ Time Frame: one week ]Physical activity measured by accelerometre
- adrenal activity [ Time Frame: 1 hour ]Adrenal recativity measured by 1 hour ACTH-stimulation test
- Ovarian morphology [ Time Frame: at baseline ]Ovarian morphology described by vaginal ultrasound with measurements of ovarian volumen and description of phollicles.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01995773
|Odense University Hospital|
|Odense, Denmark, 5000|
|Principal Investigator:||Hanne Mumm, MD||Odense University Hospital|