Glucose Metabolism and Quality of Life in Healthy Women (Healthywomen)

August 21, 2018 updated by: Marianne Andersen, Odense University Hospital

Glucose Metabolism, Adrenal Function, Cortisol Metabolism, Body Composition Physical Activity, 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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Odense, Denmark, 5000
        • Odense University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Healthy Controls
Healthy control women

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of androgens
Time Frame: baseline
Level of testosterone and sexual hormone binding globuline in blood samples
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: Baseline
Quality of life measured by validated questionnaires
Baseline
Body composition
Time Frame: baseline
Body composition measured by full body DXA-scan with estimates on lean body mass and fat mass
baseline
Bone density
Time Frame: baseline
Bone density measured by DXA scan of hip and wrist
baseline
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
5 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
physical activity
Time Frame: one week
Physical activity measured by accelerometre
one week
adrenal activity
Time Frame: 1 hour
Adrenal recativity measured by 1 hour ACTH-stimulation test
1 hour
Ovarian morphology
Time Frame: at baseline
Ovarian morphology described by vaginal ultrasound with measurements of ovarian volumen and description of phollicles.
at baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Odense University Hospital

Investigators

  • Principal Investigator: Hanne Mumm, MD, Odense University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

November 21, 2013

First Submitted That Met QC Criteria

November 26, 2013

First Posted (Estimate)

November 27, 2013

Study Record Updates

Last Update Posted (Actual)

August 23, 2018

Last Update Submitted That Met QC Criteria

August 21, 2018

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 280278 (Other Identifier: Odense University Hospital)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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