Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2026-01-04 @ 11:34 PM
Study NCT ID:
NCT03142633
Status:
COMPLETED
Last Update Posted:
2019-02-27
First Post:
2017-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MicroRNA as Biomarkers for Development of Metabolic Syndrome in Women With Polycystic Ovary Syndrome
Sponsor:
Holbaek Sygehus
Organization:
Study Overview
Official Title:
MicroRNA as Biomarkers for Development of Metabolic Syndrome in Women With Polycystic Ovary Syndrome
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to explore the microRNA profile in serum of women with Polycystic Ovary Syndrome and investigate the correlation between the microRNA profile and markers of metabolic syndrome.
Detailed Description:
The study consist of 2 parts:
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: