Clinical trial NCT03142633: MicroRNA as Biomarkers for Development of Metabolic Syndrome in Women With Polycystic Ovary Syndrome
Official title: MicroRNA as Biomarkers for Development of Metabolic Syndrome in Women With Polycystic Ovary Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polycystic Ovary Syndrome
Insulin Resistance
Lead sponsor: Holbaek Sygehus
Sponsor class: OTHER
First posted: 2017-05-05
Enrollment: 55
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Local Participants from the PICOLO study, performed at Holbæk Hospital between 2010 and 2013

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.

Eligibility criteria: Inclusion Criteria:

* Women between 18 and 40 years when included in the PICOLO study
* PCOS based on the Rotterdam 2003 consensus criteria

Exclusion Criteria:

* Contraceptive pills within 8 weeks from examination,
* endocrinological disease (i.e. type 1 diabetes thyroid dysfunction),
* Severe endometriosis (stage III and IV)
* Premature ovarian insufficiency,
* Breastfeeding women and
* Pregnancy.

Primary outcomes:
measure: MicroRNA profile
timeFrame: 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.
Secondary outcomes:
measure: Insulin Resistance and Type 2 Diabetes
timeFrame: The participants will be examined for 2 hours, at a follow-up visit 5 years after the baseline visit.
measure: Blood Pressure
timeFrame: The participants will be examined for 2 hours, at a follow-up visit 5 years after the baseline visit.
measure: Abdominal obesity
timeFrame: The participants will be examined for 2 hours, at a follow-up visit 5 years after the baseline visit.
measure: Overweight
timeFrame: The participants will be examined for 2 hours, at a follow-up visit 5 years after the baseline visit.
measure: Dyslipidemia
timeFrame: The participants will be examined for 2 hours, at a follow-up visit 5 years after the baseline visit.
measure: PCOS status
timeFrame: The participants will be examined for 2 hours, at a follow-up visit 5 years after the baseline visit.
Other outcomes:
Locations:
city: Holbaek
country: Denmark
facility: Fertility Clinic,Department of Gynecology and Obstetrics
Study officials:
affiliation: Fertility Clinic, Dept. of Gynecology and Obstetrics, Holbæk Hospital
name: Anne Lis M Englund, DsMC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.