MicroRNA as Biomarkers for Development of Metabolic Syndrome in Women With Polycystic Ovary Syndrome
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|ClinicalTrials.gov Identifier: NCT03142633|
Recruitment Status : Completed
First Posted : May 5, 2017
Last Update Posted : February 27, 2019
|Condition or disease|
|Polycystic Ovary Syndrome Insulin Resistance|
The study consist of 2 parts:
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.
- 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 Type :||Observational|
|Actual Enrollment :||55 participants|
|Official Title:||MicroRNA as Biomarkers for Development of Metabolic Syndrome in Women With Polycystic Ovary Syndrome|
|Actual Study Start Date :||September 9, 2016|
|Actual Primary Completion Date :||May 23, 2017|
|Actual Study Completion Date :||May 23, 2017|
Women with Polycystic Ovary Syndrome
Participants of the PICOLO study
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.
- MicroRNA profile [ Time Frame: MicroRNA analysis will be performed on serum from baseline visit (biobank material) and on serum obtained from a follow-up visit 5 years after baseline. The participants will be examined for 2 hours at follow up. ]The change in relative expression of MicroRNA in women with PCOS will be assessed, using TaqMan microRNA arrays, comparing serum samples from baseline from an existing biobank with serum samples from a follow up visit.
- Insulin Resistance and Type 2 Diabetes [ Time Frame: The participants will be examined for 2 hours, at a follow-up visit 5 years after the baseline visit. ]Insulin Resistance will be assessed by Oral glucose Tolerance test (OGTT). Venous blood samples and measurement of glucose, serum insulin and C-peptid will be collected at -5, 0, 30 and 120 min after a 75 g glucose load. Impaired glucose tolerance will be assessed by calculation of BIGTTs1(insulin sensitivity index) and BIGTTAIR(Acute insulin response)
- Blood Pressure [ Time Frame: The participants will be examined for 2 hours, at a follow-up visit 5 years after the baseline visit. ]Evaluated > 140/90 mmHg
- Abdominal obesity [ Time Frame: The participants will be examined for 2 hours, at a follow-up visit 5 years after the baseline visit. ]Waist-Hip Ratio. Elevated > 0,85
- Overweight [ Time Frame: The participants will be examined for 2 hours, at a follow-up visit 5 years after the baseline visit. ]Defined: BMI > 25 kg/m2
- Dyslipidemia [ Time Frame: The participants will be examined for 2 hours, at a follow-up visit 5 years after the baseline visit. ]Defined as triglycerides > 1,7mmol/L, Total cholesterol > 5,0, LDL > 3,0 or HDL<1,0 mmol/L
- PCOS status [ Time Frame: The participants will be examined for 2 hours, at a follow-up visit 5 years after the baseline visit. ]
Evaluated by Rotterdam (2003) criteria:
1. Polycystic Ovaries:Number of antral follicles >12, ovarian volume (length*depth*width/2) > 10 mL 2) Clinical (evaluated by Ferriman Gallway score) or biochemical signs of hyperandrogenism ( Free Testosterone > 0.034 nmol/Lor total testosterone >1.8 nmol/L) 3.Oligo or amenorrhea ´(>35 days between bleedings)
Biospecimen Retention: Samples With DNA
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): NCT03142633
|Fertility Clinic,Department of Gynecology and Obstetrics|
|Holbaek, Denmark, 4300|
|Principal Investigator:||Anne Lis M Englund, DsMC||Fertility Clinic, Dept. of Gynecology and Obstetrics, Holbæk Hospital|