MicroRNA as Biomarkers for Development of Metabolic Syndrome in Women With Polycystic Ovary Syndrome
NCT ID: NCT03142633
Last Updated: 2019-02-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
55 participants
OBSERVATIONAL
2016-09-09
2017-05-23
Brief Summary
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Detailed Description
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1. A cross-sectional study of a cohort of women with PCOS with analysis of materials from the established biobank. (the PICOLO cohort) Data and blood samples from 266 women with PCOS was collected from January 2010 - February 2013 as a part of the PICOLO collaboration: "PCOS, infertility, Cardiovascular and Obstetric risk markers and Long-term Outcome" at Holbaek Fertility Clinic and at Herlev Hospital.
Serum samples will be analysed with Reverse Transcript polymerase chain Reaction (RT-qPCR) for selected microRNAs.
2. A follow-up study of local participants from the PICOLO study. 90 of the participants were recruited at Holbaek Fertility Clinic.
Following tests will be performed at reexamination, in order to describe the clinical phenotype: Health interview, anthropometrics, acne score, Ferriman-Gallway score, blood pressure, Transvaginal ultrasound of uterus and ovaries, insulin Resistance (IR) assessed with Oral glucose Tolerance test (OGTT), Venous blood for hormone analysis and lipid status.
MicroRNA analysis with Taqman microRNA array will be performed on serum samples.
Detection and treatment of women with PCOS is a challenge due to the variability of the syndrome. If MiRNA could serve as marker of metabolic syndrome, it would be possible to detect and follow the women of greater risk at an earlier stage, and thereby preventing morbidity.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Women with Polycystic Ovary Syndrome
Participants of the PICOLO study
Inclusion criteria:
Women aged 18-40 years when included in the PICOLO-cohort, PCOS based on the Rotterdam 2003 consensus criteria Exclusion criteria: Contraceptive pills within 6 weeks from examination, endocrinological disease (i.e. diabetes, thyroid dysfunction), endometriosis and premature ovarian insufficiency, breastfeeding women and pregnancy.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* PCOS based on the Rotterdam 2003 consensus criteria
Exclusion Criteria
* endocrinological disease (i.e. type 1 diabetes thyroid dysfunction),
* Severe endometriosis (stage III and IV)
* Premature ovarian insufficiency,
* Breastfeeding women and
* Pregnancy.
18 Years
45 Years
FEMALE
No
Sponsors
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Holbaek Sygehus
OTHER
Responsible Party
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Principal Investigators
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Anne Lis M Englund, DsMC
Role: PRINCIPAL_INVESTIGATOR
Fertility Clinic, Dept. of Gynecology and Obstetrics, Holbæk Hospital
Locations
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Fertility Clinic,Department of Gynecology and Obstetrics
Holbæk, , Denmark
Countries
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References
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Udesen PB, Sorensen AE, Svendsen R, Frisk NLS, Hess AL, Aziz M, Wissing MLM, Englund ALM, Dalgaard LT. Circulating miRNAs in Women with Polycystic Ovary Syndrome: A Longitudinal Cohort Study. Cells. 2023 Mar 23;12(7):983. doi: 10.3390/cells12070983.
Udesen PB, Sorensen AE, Joglekar MV, Hardikar AA, Wissing MLM, Englund AM, Dalgaard LT. Levels of circulating insulin cell-free DNA in women with polycystic ovary syndrome - a longitudinal cohort study. Reprod Biol Endocrinol. 2019 Apr 5;17(1):34. doi: 10.1186/s12958-019-0478-7.
Other Identifiers
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SJ-525
Identifier Type: -
Identifier Source: org_study_id
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