Glucose Metabolism and Quality of Life in Healthy Women

Completed

• Conditions: Healthy

• Registration Number: NCT01995773
• Lead Sponsor: Odense University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Primary Completion: 2013-01
• Study Completion: 2013-06
• Status Verified: 2013-11
• Study First Submitted: 2013-11-21
• Study First Submitted QC: 2013-11-26
• Study First Posted: 2013-11-27
• Last Update Submitted: 2018-08-21
• Last Update Posted: 2018-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• healthy
• No medications
• regular menstrual cycle
• no hair growth problems
• BMI 18-35 kg/m2

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Exclusion Criteria

• medication
• diabetes mellitus
• signs of PCOS
• BMI < 18 or > 35

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Level of androgens	baseline	Level of testosterone and sexual hormone binding globuline in blood samples

Secondary Outcome Measures

Name	Time	Method
Body composition	baseline	Body composition measured by full body DXA-scan with estimates on lean body mass and fat mass
Bone density	baseline	Bone density measured by DXA scan of hip and wrist
Glucose tolerance	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
Quality of life	Baseline	Quality of life measured by validated questionnaires

Trial Locations

Locations (1)

Odense University Hospital; 🇩🇰 Odense, Denmark