An observational study in Polycystic Ovary Syndrome and Insulin Resistance, sponsored by Holbaek Sygehus. Completed at 1 site in Denmark. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2019-02-27.
Sponsored by Holbaek Sygehus · Observational
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.
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.
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.
975 studies on the registry are indexed under Polycystic Ovary Syndrome; 177 are open to participants now.
This study's enrollment of 55 is below the median of 106 across 229 observational studies indexed under Polycystic Ovary Syndrome.
Browse Polycystic Ovary Syndrome studies →Holbaek Sygehus is the lead sponsor of 27 studies on the registry; 4 are open to participants now.
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Local Participants from the PICOLO study, performed at Holbæk Hospital between 2010 and 2013
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
MicroRNA profile
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.
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.
Insulin Resistance and Type 2 Diabetes
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)
Time frame: The participants will be examined for 2 hours, at a follow-up visit 5 years after the baseline visit.
Blood Pressure
Evaluated \> 140/90 mmHg
Time frame: The participants will be examined for 2 hours, at a follow-up visit 5 years after the baseline visit.
Abdominal obesity
Waist-Hip Ratio. Elevated \> 0,85
Time frame: The participants will be examined for 2 hours, at a follow-up visit 5 years after the baseline visit.
Overweight
Defined: BMI \> 25 kg/m2
Time frame: The participants will be examined for 2 hours, at a follow-up visit 5 years after the baseline visit.
Dyslipidemia
Defined as triglycerides \> 1,7mmol/L, Total cholesterol \> 5,0, LDL \> 3,0 or HDL\<1,0 mmol/L
Time frame: The participants will be examined for 2 hours, at a follow-up visit 5 years after the baseline visit.
PCOS status
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)
Time frame: The participants will be examined for 2 hours, at a follow-up visit 5 years after the baseline visit.
Plan to share: Undecided
Ran from Sep 2016 to primary completion in May 2017, 8 months.
Of 70 non-industry observational studies under Polycystic Ovary Syndrome, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 48. This study's 8 months is below that.
Counting every sponsor, half of 73 studies reached it within 16 months; a quarter within 6 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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Holbaek Sygehus