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Trial record 2 of 2 for:    SCUBE1

Evaluation of Serum Scube-1 Scube-2 and Scube-3 Levels in Patients With Polikistik Over Syndrome ,

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ClinicalTrials.gov Identifier: NCT03765905
Recruitment Status : Completed
First Posted : December 5, 2018
Last Update Posted : December 6, 2018
Sponsor:
Information provided by (Responsible Party):
Suleyman Guven, Karadeniz Technical University

Brief Summary:
The aim of this study is to investigate serum SCUBE-1 and SCUBE-3 levels in PCOS and non-PCOS cases compared with non-PCOS healthy controls with similar age and body mass index

Condition or disease Intervention/treatment
Polycystic Ovary Syndrome Diagnostic Test: study

Detailed Description:

The aim of this study was to investigate serum SCUBE1 and SCUBE3 levels in PCOS and non-PCOS cases compared with non-PCOS healthy controls with similar age and body mass index.

This will be a prospective clinical laboratory study,It will include women with PCOS diagnosis (according to the 2003 Rotherdam criteria). 40 cases of reproductive age will be included in the study group, which will be included in the survey after being approved for participation in the survey from field trials. Forty patients who will not have any complaints between the ages of 18-35 who will apply to the gynecology policlinic as a control group but who had no PCOS o rany other systemic problems and will be similar in terms of age group and body mass index will be included in the study after being approved for participation in the study. From the study and control group, 5 mL of blood will be taken from the untreated biochemical tube for serum SCUBE1 SCUBE2 SCUBE3. The blood samples will be centrifuged at 1000 g for 10 minutes and the serum fraction will be obtained and the serum will be stored at -80 ° C to be stored until the day of the tube operation. Serum SCUBE1, SCUBE2 SCUBE3 levels will be measured using ELISA kits. ,


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Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Evaluation of Serum Scube-1 Scube-2 and Scube-3 Levels in Patients With Polikistik Over Syndrome ,
Actual Study Start Date : December 1, 2017
Actual Primary Completion Date : February 1, 2018
Actual Study Completion Date : February 1, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
PCOS diagnosis area
The study group consisted of 40 reproductive age women between 18th and 35th years old women who were PCOS diagnosis (according to the 2003 Rotherdam criteria)
Diagnostic Test: study
Scube-1 scube-2 scube-3

PCOS is not diagnosed
Forty patients who did not have any complaints between the ages of 18-35 who applied to the gynecology policlinic as a control group but who had no PCOS orany other systemic problems and were similar in terms of age group and body mass index were included in the study after being approved for participation in the study
Diagnostic Test: study
Scube-1 scube-2 scube-3




Primary Outcome Measures :
  1. Serum SCUBE 1 [ Time Frame: 01.01.2017-31.12.2017 ]
    Serum scube1 in microgram

  2. Serum SCUBE 2 [ Time Frame: 01.01.2017-31.12.2017 ]
    Serum scube2 in microgram

  3. Serum SCUBE 3 [ Time Frame: 01.01.2017-31.12.2017 ]
    Serum scube3 in microgram


Biospecimen Retention:   Samples Without DNA
Blood serum


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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
40 women diagnosed with PCOS between the ages of 18-35
Criteria

Inclusion Criteria

  • Clinical diagnosis of PCOS
  • 18-35 years old

Exclusion Criteria

  • Endocrinopathies (including diabetes mellitus, hyperprolactinemia, Cushing's disease and congenital adrenal hyperplasia), systemic disease (eg asthma), collagen disorder, hypercholesterolemia, sickle cell anemia or neoplasm,
  • Coronary artery disease , angina or myocardial infarction, or any known vascular, infectious, or inflammatory disease, including hypertension, coronary arterioscitis, and electrocardiographic changes;
  • Use of any medication (e.g., insulin sensitizing drugs, oral contraceptives, antiandrogens, statins, aspirin, corticosteroids and gonadotropin releasing hormone agonists and antagonists) within the previous 3 months;
  • Abnormal serum albumin concentration (normal concentration, 30-55 g / l),
  • Abnormal troponin I concentration,
  • Present smoker,
  • Abnormal renal, hepatic and thyroid function test results;
  • Refusing to participate in the work.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03765905


Locations
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Turkey
Karadeniz Technical University Faculty of Medicine
Trabzon, Ortahisar, Turkey, 61000
Sponsors and Collaborators
Karadeniz Technical University
Investigators
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Principal Investigator: Süleyman Güven, Prof Karadeniz TU Medicine Faculty

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Responsible Party: Suleyman Guven, Clinical professor, Karadeniz Technical University
ClinicalTrials.gov Identifier: NCT03765905     History of Changes
Other Study ID Numbers: Karadeniz Technical University
First Posted: December 5, 2018    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Suleyman Guven, Karadeniz Technical University:
PCOS
SCUBE
Cardiovascular disease
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases