Adipocytokines and Polycystic Ovary Syndrome (PCOS) | NCT00975832

Studies
Adipocytokines and Polycystic Ovary Syndrome (PCOS)

NCT00975832

Sponsor

Hvidovre University Hospital

Status

Completed

Last Update Posted

Sep 11, 2009Estimated

Enrollment

60Actual

Phase

Not provided

Conditions

Polycystic Ovary Syndrome

Interventions

Not provided

Countries

Not provided

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

Sep 2009

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

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 10, 2009

First Submission Date that Met QC Criteria

Sep 10, 2009

First Posted Date

Sep 11, 2009Estimated

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

Sep 10, 2009

Last Update Posted Date

Sep 11, 2009Estimated

Name	Class
Statens Serum Institut	OTHER
Aarhus University Hospital	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

Inflammation may play a role in the development of polycystic ovary syndrome (PCOS). In this study, the investigators investigated the expression of different mediators of inflammation in fatty tissue and in blood in women with and without 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

No data available

No data is available for this block.

Enrollment

60Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women with PCOS were included according to the Rotterdam diagnostic criteria for PCOS. Control women met none of the criteria for PCOS

Exclusion Criteria:

Oc´s within the last three months, or other medication known to alter glucose/insulin metabolism
Other known chronic diseases

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

36 women (17 lean and 19 obese)with PCOS and 24 (8 lean and 16 obese) control women

Sampling Method

Non-Probability Sample

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22607892	Derived	Svendsen PF, Christiansen M, Hedley PL, Nilas L, Pedersen SB, Madsbad S. Adipose expression of adipocytokines in women with polycystic ovary syndrome. Fertil Steril. 2012 Jul;98(1):235-41. doi: 10.1016/j.fertnstert.2012.03.056. Epub 2012 May 16.

Label	Type	Description	Intervention Names
women with polycystic ovary syndrome
women without polycystic ovary syndrome
women from 18-40 years of age

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