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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
Sponsor:
Information provided by (Responsible Party):
Marianne Andersen, Odense University Hospital

Study Description
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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.


Condition or disease
Healthy

Study Design
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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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
Groups and Cohorts
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Group/Cohort
Healthy Controls
Healthy control women


Outcome Measures
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Primary Outcome Measures :
  1. Level of androgens [ Time Frame: baseline ]
    Level of testosterone and sexual hormone binding globuline in blood samples


Secondary Outcome Measures :
  1. Quality of life [ Time Frame: Baseline ]
    Quality of life measured by validated questionnaires

  2. Body composition [ Time Frame: baseline ]
    Body composition measured by full body DXA-scan with estimates on lean body mass and fat mass

  3. Bone density [ Time Frame: baseline ]
    Bone density measured by DXA scan of hip and wrist

  4. 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


Other Outcome Measures:
  1. physical activity [ Time Frame: one week ]
    Physical activity measured by accelerometre

  2. adrenal activity [ Time Frame: 1 hour ]
    Adrenal recativity measured by 1 hour ACTH-stimulation test

  3. 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
blood and urine samples

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
40 healthy women with regular menstrual cycle, normal hair growth, and body mass index between 18 and 35 kg/m2
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Denmark
Odense University Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
Investigators
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Principal Investigator: Hanne Mumm, MD Odense University Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Marianne Andersen, DMSci, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01995773    
Other Study ID Numbers: 280278
280278 ( Other Identifier: Odense University Hospital )
First Posted: November 27, 2013    Key Record Dates
Last Update Posted: August 23, 2018
Last Verified: November 2013
Keywords provided by Marianne Andersen, Odense University Hospital:
Healthy women
Quality of life
Glucose metabolism
 Adrenal reactivity
Physical activity
Body Composition