NCT01310569

Brief Summary

This study aimed to search whether whole body and subcutaneous adipose tissues increase in PCOS patients and whether these tissues are related to HOMA-IR and plasma adiponectin levels.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2009

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 8, 2011

Completed
Last Updated

March 8, 2011

Status Verified

August 1, 2010

Enrollment Period

1.6 years

First QC Date

March 7, 2011

Last Update Submit

March 7, 2011

Conditions

Polycystic Ovary Syndrome

Keywords

PCOS, Skinfold thickness, HOMA-IR

Outcome Measures

Primary Outcomes (1)

  • Relationship of Subcutaneous Adipose Tissue with HOMA-IR and Plasma Adiponectin Levels in Cases with Polycystic Ovarian Syndrome

    PCOS patients (the experimental group) had higher mean SFT values in all parts, mid-upper arm circumference values, whole body and trunk fat free mass amounts (FFM) and HOMA-IR values, while a lower adiponectin level.

    2 year

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with PCOS witout any other metabolik diseases

You may qualify if:

  • All of the women with PCOS had normal thyroid-stimulating hormone and prolactin (PRL) levels.

You may not qualify if:

  • Subjects with possible ovarian tumors, congenital adrenal hyperplasia, BMI greater than 35 kg/m2, any chronic renal or liver disease, were excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gulhane School of Medicine Department of Endocrinology and Metabolism

Ankara, 06100, Turkey (Türkiye)

Location

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

    Gulhane School of Medicine

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 7, 2011

First Posted

March 8, 2011

Study Start

January 1, 2009

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

March 8, 2011

Record last verified: 2010-08

Locations

TU(1)