NCT01382576

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2011

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 27, 2011

Completed
Last Updated

March 12, 2012

Status Verified

December 1, 2010

Enrollment Period

11 months

First QC Date

June 10, 2011

Last Update Submit

March 9, 2012

Conditions

Polycystic Ovary Syndrome

Keywords

polycystic ovary syndromechitotriosidase activity

Study Arms (2)

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.

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gulhane School of Medicine Etlik

Ankara, 06180, Turkey (Türkiye)

Location

Biospecimen

Retention: NONE RETAINED

No biospecimens were to be retained

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • Aydogan Aydogdu, MD

    No organizational affiliation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 10, 2011

First Posted

June 27, 2011

Study Start

January 1, 2010

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

March 12, 2012

Record last verified: 2010-12

Locations

TU(1)