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Completed

NCT Number: NCT01995773

Glucose Metabolism and Quality of Life in Healthy Women

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.

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Key information

Conditions

Healthy Behavior Motor Activity

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Odense University Hospital

Odense, 5000, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Level of androgens

    Time frame: baseline

    Level of testosterone and sexual hormone binding globuline in blood samples

Secondary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Registry information

Official study title

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

Acronym: Healthywomen

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Nov 27, 2013
Registry last updated
Aug 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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