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NCT Number: NCT03142633

MicroRNA as Biomarkers for Development of Metabolic Syndrome in Women With Polycystic Ovary Syndrome

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.

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Glucose Metabolism Disorders Gonadal Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Neoplasms Nutritional and Metabolic Diseases Ovarian Cysts Ovarian Diseases Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Fertility Clinic,Department of Gynecology and Obstetrics

Holbæk, 4300, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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:

    • 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)

Sponsors and collaborators

Lead sponsor

Holbaek Sygehus

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 5, 2017
Registry last updated
Feb 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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