Metabolic Disturbances in Polycystic Ovary Syndrome (PCOS) | NCT00606671

Studies
Metabolic Disturbances in Polycystic Ovary Syndrome (PCOS)

NCT00606671

Sponsor

Hvidovre University Hospital

Status

Completed

Last Update Posted

Feb 4, 2008Estimated

Enrollment

65Actual

Phase

Not provided

Conditions

Polycystic Ovary Syndrome

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

Status Module

Record Verification Date

Jan 2008

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

Feb 2004

Primary Completion Date

May 2006Actual

Completion Date

May 2006Actual

First Submitted Date

Jan 17, 2008

First Submission Date that Met QC Criteria

Feb 1, 2008

First Posted Date

Feb 4, 2008Estimated

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

Feb 1, 2008

Last Update Posted Date

Feb 4, 2008Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Hvidovre University HospitalOTHER

Collaborators

Name	Class
Diabetesforeningen	OTHER
Danish Hospital foundation for medical research. region Copenhagen, The Faroe Islands and Greenland.	UNKNOWN
Aage Bangs Fond	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The scope of the study was to investigate different metabolic aspects that may lead to or are a consequence of insulin resistance in premenopausal women with polycystic ovary syndrome (PCOS). We use gold standard methods for evaluation of insulin resistance. We take muscle and fat biopsies for investigation of gene expression of different cytokines associated with insulin resistance. We investigate the incretin hormones GIP and GLP-1. These two hormones play a central role in glycemic control, and diabetic subjects are known to have alterations in their incretin hormones. The incretin hormones have not previously been investigated in women with PCOS.

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

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

65Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		lean control women without PCOS
2		lean women with PCOS
3		Obese control women without PCOS
4		Obese women with PCOS
1xx - 04 LC		lean control women
1xx-04 LP		lean women with PCOS
1xx-04 OC		obese control women
1xx-04 OP		obese women with PCOS

Interventions

Not provided

Measure	Description	Time Frame
insulin resistance		2004-2006

Measure	Description	Time Frame
gene expression of cytokines in fatty tissue		2004-2006

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Premenopausal women that meet the Rotterdam criteria for PCOS (BMI < 40)
Age and BMI matched control women that do not have any signs or symptoms of PCOS

Exclusion Criteria:

BMI > 40. mani fest diabetes or other known diseases

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

38 Years

Standard Ages

Adult

Study Population

lean and obese women with and without PCOS

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pernille Fog Svendsen, MD	Dpt. of Obstetrics and Gynaecology, Copenhagen University Hospital, Hvidovre	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dpt. of Obstetrics and Gynaecology, Copenhagen University Hospital, Hvidovre		Hvidovre		2650	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D011085	Polycystic Ovary Syndrome

Ancestor Terms

ID	Term
D010048	Ovarian Cysts
D003560	Cysts
D009369	Neoplasms
D010049	Ovarian Diseases
D000291

Browse Leaves

Not provided

Browse Branches

Not provided