Glucose Metabolism and Quality of Life in Healthy Women

Healthy Clinical Trial

— Healthywomen  

Official title:

Glucose Metabolism, Adrenal Function, Cortisol Metabolism, Body Composition Physical Activity, and Quality of Life in Healthy Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01995773
• Other study ID #: 280278
• Secondary ID: 280278
• Status: Completed
• Start date: December 2011
• Est. completion date: June 2013

Study information

• Verified date: November 2013
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• healthy

• No medications

• regular menstrual cycle

• no hair growth problems

• BMI 18-35 kg/m2

Exclusion Criteria:

• medication

• diabetes mellitus

• signs of PCOS

• BMI < 18 or > 35

Related Conditions & MeSH terms

• Healthy

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	physical activity	Physical activity measured by accelerometre	one week
Other	adrenal activity	Adrenal recativity measured by 1 hour ACTH-stimulation test	1 hour
Other	Ovarian morphology	Ovarian morphology described by vaginal ultrasound with measurements of ovarian volumen and description of phollicles.	at baseline
Primary	Level of androgens	Level of testosterone and sexual hormone binding globuline in blood samples	baseline
Secondary	Quality of life	Quality of life measured by validated questionnaires	Baseline
Secondary	Body composition	Body composition measured by full body DXA-scan with estimates on lean body mass and fat mass	baseline
Secondary	Bone density	Bone density measured by DXA scan of hip and wrist	baseline
Secondary	Glucose tolerance	Glucose tolerance measured by 5 hour oral glucose tolerance test with blood glucose measurements for 5 hours after oral intake of 75 g glucose	5 hours