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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
Sponsor:
Information provided by (Responsible Party):
Holbaek Sygehus

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.

Condition or disease
Polycystic Ovary Syndrome Insulin Resistance

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.


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Study Type : Observational
Actual Enrollment : 55 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort
Women with Polycystic Ovary Syndrome

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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:

    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
Serum Buffy Coat


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Local Participants from the PICOLO study, performed at Holbæk Hospital between 2010 and 2013
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.

Information from the National Library of Medicine

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


Locations
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Denmark
Fertility Clinic,Department of Gynecology and Obstetrics
Holbaek, Denmark, 4300
Sponsors and Collaborators
Holbaek Sygehus
Investigators
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Principal Investigator: Anne Lis M Englund, DsMC Fertility Clinic, Dept. of Gynecology and Obstetrics, Holbæk Hospital

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Responsible Party: Holbaek Sygehus
ClinicalTrials.gov Identifier: NCT03142633     History of Changes
Other Study ID Numbers: SJ-525
First Posted: May 5, 2017    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Syndrome
Metabolic Syndrome
Insulin Resistance
Polycystic Ovary Syndrome
Disease
Pathologic Processes
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases