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Trial registered on ANZCTR


Registration number
ACTRN12613001132730
Ethics application status
Approved
Date submitted
4/10/2013
Date registered
11/10/2013
Date last updated
11/10/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Interactions of osteocalcin, adiponectin, tumor necrosis factor alpha and insulin resistance in polycystic ovary syndrome
Scientific title
Interactions of osteocalcin, adiponectin, tumor necrosis factor alpha and insulin resistance in polycystic ovary syndrome
Secondary ID [1] 283377 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
polycystic ovary syndrome 290252 0
Condition category
Condition code
Reproductive Health and Childbirth 290643 290643 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
6
Target follow-up type
Months
Description of intervention(s) / exposure
Blood levels of hormones is assesed during administration to our clinic. These are thyroid stimulating hormone, cortisol, dehydroepiandrosterone sulfate, prolactin, luteinizing hormone, follicle-stimulating hormone, estradiol, 17-hydroxyprogesterone, Androstenedione, Adiponectin, TNF alpha, osteocalcine, free testosterone, total testosterone, insulin and sex hormone binding globulin levels. We assessed at baseline and then again 6 months later.
Intervention code [1] 288078 0
Not applicable
Comparator / control treatment
Participants are healthy controls. Blood levels of hormones is assesed during administration to our clinic. These are thyroid stimulating hormone, cortisol, dehydroepiandrosterone sulfate, prolactin, luteinizing hormone, follicle-stimulating hormone, estradiol, 17-hydroxyprogesterone, Androstenedione, Adiponectin, TNF alpha, osteocalcine, free testosterone, total testosterone, insulin and sex hormone binding globulin levels. We assessed at baseline and then again 6 months later.
Control group
Active

Outcomes
Primary outcome [1] 290658 0
to evaluate the correlations of blood osteocalcin with IR, adiponectin, and TNF-a in PCOS and we matched these parameters with healthy controls
Timepoint [1] 290658 0
6 months
Secondary outcome [1] 304988 0
Hormonal analyses included; thyroid stimulating hormone (TSH), cortisol, dehydroepiandrosterone sulfate (DHEAS), prolactin (PRL), luteinizing hormone (LH), follicle-stimulating hormone (FSH), estradiol (E2), 17-hydroxyprogesterone (17-OH-P), Androstenedione (A), free testosterone (fT), total testosterone (tT), insulin and sex hormone binding globulin (SHBG) levels. tT and fT (Biosource-Nivelles-Belgium), 17 OHP (DSL-3500, Texas USA), DHEAS (Immunotech, Marseille, France), A (DSL- 3800, Texas, USA) were measured by using an immunoradiometric assay method and its commercial kit, serum SHBG (Zentech, Angleur, Belgium), insulin (Biosource, Nivelles, Belgium), LH, FSH, P, PRL (ACS:180, Bayer, Germany) were measured by using a chemiluminescence method and its commercial kit.
Timepoint [1] 304988 0
6 months

Eligibility
Key inclusion criteria
A total of 74 women including 55 PCOS patients (group-1) and 19 healthy women (group-2) were studied.
Minimum age
18 Years
Maximum age
35 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous medication with hormone ( 6 months prior to study), liver disease, kidney disease, cardiac and vascular disorders

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Case control
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 5464 0
Turkey
State/province [1] 5464 0
Kayseri

Funding & Sponsors
Funding source category [1] 288084 0
University
Name [1] 288084 0
Erciyes University
Address [1] 288084 0
Erciyes University Talas Street Kayseri/Turkey 38010
Country [1] 288084 0
Turkey
Primary sponsor type
University
Name
Erciyes University
Address
Erciyes University Talas Street Kayseri/Turkey 38010
Country
Turkey
Secondary sponsor category [1] 286807 0
None
Name [1] 286807 0
None
Address [1] 286807 0
None
Country [1] 286807 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290010 0
Erciyes University Ethics Committe
Ethics committee address [1] 290010 0
Erciyes University Talas Street Kayseri/Turkey 38010
Ethics committee country [1] 290010 0
Turkey
Date submitted for ethics approval [1] 290010 0
03/08/2011
Approval date [1] 290010 0
16/09/2011
Ethics approval number [1] 290010 0
2011/369

Summary
Brief summary
Objective: Insulin resistance (IR) seems to be main pathogenic factor in polycystic ovary syndrome (PCOS). Osteocalcin, adiponectin and tumor necrosis factor alpha (TNF-a) are also implicated from IR. The aim of this study was to evaluate the correlations of osteocalcin with IR, adiponectin, and TNF-a in PCOS.
Study Design: A total of 74 women were divided into two groups. Group 1 was constituted from 55 PCOS patients and group 2 was constituted from 19 healthy women. Adiponectin, TNF-a, osteocalcine, hormonal levels, body mass index, IR in the fasting state were assessed and correlations of these parameters with each other were evaluated in 74 women.
Trial website
Trial related presentations / publications
No we did not publish our data.
Public notes

Contacts
Principal investigator
Name 43450 0
Dr Gokhan Acmaz
Address 43450 0
Kayseri Education and Research Hospital of Medicine Hastane Street Kocasinan/Kayseri 38210
Country 43450 0
Turkey
Phone 43450 0
90 352 338 21 49
Fax 43450 0
Email 43450 0
gokhanacmaz@gmail.com
Contact person for public queries
Name 43451 0
Dr Gokhan Acmaz
Address 43451 0
Kayseri Education and Research Hospital of Medicine Hastane Street Kocasinan/Kayseri 38210
Country 43451 0
Turkey
Phone 43451 0
90 352 338 21 49
Fax 43451 0
Email 43451 0
gokhanacmaz@gmail.com
Contact person for scientific queries
Name 43452 0
Dr Gokhan Acmaz
Address 43452 0
Kayseri Education and Research Hospital of Medicine Hastane Street Kocasinan/Kayseri 38210
Country 43452 0
Turkey
Phone 43452 0
90 352 338 21 49
Fax 43452 0
Email 43452 0
gokhanacmaz@gmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary