Healthywomen: Glucose Metabolism and Quality of Life in Healthy Women

• Sponsor: Odense University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01995773
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Duration (Months): 18
• Patients Per Site Per Month: 2.2

Study Details

Study Description

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	Intervention/Treatment	Phase
Healthy

Study Design

• 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: Dec 1, 2011
• Actual Primary Completion Date: Jan 1, 2013
• Actual Study Completion Date: Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Healthy Controls Healthy control women

Outcome Measures

Primary Outcome Measures

1. Level of androgens [baseline]

   Level of testosterone and sexual hormone binding globuline in blood samples

Secondary Outcome Measures

1. Quality of life [Baseline]

   Quality of life measured by validated questionnaires

2. Body composition [baseline]

   Body composition measured by full body DXA-scan with estimates on lean body mass and fat mass

3. Bone density [baseline]

   Bone density measured by DXA scan of hip and wrist

4. 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

Other Outcome Measures

1. physical activity [one week]

   Physical activity measured by accelerometre

2. adrenal activity [1 hour]

   Adrenal recativity measured by 1 hour ACTH-stimulation test

3. Ovarian morphology [at baseline]

   Ovarian morphology described by vaginal ultrasound with measurements of ovarian volumen and description of phollicles.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Odense University Hospital	Odense		Denmark	5000

Sponsors and Collaborators

• Odense University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Marianne Andersen, DMSci, Odense University Hospital
• ClinicalTrials.gov Identifier: NCT01995773
• Other Study ID Numbers: 280278; 280278
• First Posted: Nov 27, 2013
• Last Update Posted: Aug 23, 2018
• Last Verified: Nov 1, 2013

• Keywords provided by Marianne Andersen, DMSci, Odense University Hospital: Healthy women; Quality of life; Glucose metabolism; Adrenal reactivity; Physical activity; Body Composition

Study Results

No Results Posted as of Aug 23, 2018