Women With Polycystic Ovary Syndrome Have Increased Plasm... | NCT01382576

Studies
Women With Polycystic Ovary Syndrome Have Increased Plasma Chitotriosidase Activity

NCT01382576

Sponsor

Gulhane School of Medicine

Status

Completed

Last Update Posted

Mar 12, 2012Estimated

Enrollment

78Actual

Phase

Not provided

Conditions

Polycystic Ovary Syndrome

Interventions

Not provided

Countries

Turkey (Türkiye)

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
Chitotriosidase activity	Other Grant/Funding Number	1202-0811

Status Module

Record Verification Date

Dec 2010

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

Jan 2010

Primary Completion Date

Dec 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Jun 10, 2011

First Submission Date that Met QC Criteria

Jun 24, 2011

First Posted Date

Jun 27, 2011Estimated

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

Mar 9, 2012

Last Update Posted Date

Mar 12, 2012Estimated

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

In the present study, serum chitotriosidase activity and its relationship with insulin resistance were determined in patients with Polycystic Ovary Syndrome (PCOS).

Detailed Description

ChT activity is increased in patients with PCOS in concordance with insulin resistance. These findings may reflect the pronounced risk for metabolic syndrome and atherosclerotic diseases in this particular patient group.

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

78Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PCOS patients
PCOS patients and healthy controls		There are two groups in this study. One group is PCOS patients and other group is healthy controls.

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Absence of significant abnormalities on physical examination except hirsutism
no lipid lowering, hypoglycemic, antihypertensive or hormone replacement therapy
normal thyroid function and prolactin level
absence of history or evidence of metabolic, cardiovascular, respiratory or hepatic disease

Exclusion Criteria:

Pregnant
ovarian tumors
congenital adrenal hyperplasia or BMI greater than 30 kg/m2

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

34 women with PCOS and 44 healty women as control group.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Aydogan Aydogdu, MD	No organizational affiliation	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gulhane School of Medicine Etlik		Ankara		06180	Turkey (Türkiye)

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