Glucose Metabolism and Quality of Life in Healthy Women | NCT01995773

Studies
Glucose Metabolism and Quality of Life in Healthy Women

NCT01995773

Sponsor

Odense University Hospital

Status

Completed

Last Update Posted

Aug 23, 2018Actual

Enrollment

40Actual

Phase

Not provided

Conditions

Healthy

Interventions

Not provided

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
280278	Other Identifier	Odense University Hospital

Status Module

Record Verification Date

Nov 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2011

Primary Completion Date

Jan 2013Actual

Completion Date

Jun 2013Actual

First Submitted Date

Nov 21, 2013

First Submission Date that Met QC Criteria

Nov 26, 2013

First Posted Date

Nov 27, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 21, 2018

Last Update Posted Date

Aug 23, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

40Actual

Label	Type	Description	Intervention Names
Healthy Controls		Healthy control women

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Quality of life	Quality of life measured by validated questionnaires	Baseline
Body composition	Body composition measured by full body DXA-scan with estimates on lean body mass and fat mass

Other Outcomes

Measure	Description	Time Frame
physical activity	Physical activity measured by accelerometre	one week
adrenal activity	Adrenal recativity measured by 1 hour ACTH-stimulation test

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

40 healthy women with regular menstrual cycle, normal hair growth, and body mass index between 18 and 35 kg/m2

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hanne Mumm, MD	Odense University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Odense University Hospital		Odense		5000	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27008892	Derived	Mumm H, Altinok ML, Henriksen JE, Ravn P, Glintborg D, Andersen M. Prevalence and possible mechanisms of reactive hypoglycemia in polycystic ovary syndrome. Hum Reprod. 2016 May;31(5):1105-12. doi: 10.1093/humrep/dew046. Epub 2016 Mar 23.