Polycystic Ovary SyndromeNCT03142633
MicroRNA as Biomarkers for Development of Metabolic Syndrome in Women With Polycystic Ovary Syndrome
An observational study of Polycystic Ovary Syndrome and Insulin Resistance, run by Holbaek Sygehus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome, Insulin Resistance
- Type of treatment
- Pill or oral medicine
- How many people
- 55 participants
- Where
- 1 siteDenmark
- Study dates
- 9 Sep 2016to 23 May 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Local Participants from the PICOLO study, performed at Holbæk Hospital between 2010 and 2013
Who may be able to join
- Women between 18 and 40 years when included in the PICOLO study
- PCOS based on the Rotterdam 2003 consensus criteria
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Fertility Clinic,Department of Gynecology and Obstetrics
Holbæk, 4300
About this study
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.
Read the detailed description
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.
- Conditions
- Polycystic Ovary Syndrome, Insulin Resistance
- Medical subject headings
- Polycystic Ovary Syndrome, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (6)
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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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:
- 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)
Measured: The participants will be examined for 2 hours, at a follow-up visit 5 years after the baseline visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2017
- Study start9 Sep 2016
- Primary completion23 May 2017
- Study completion23 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Holbaek Sygehus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne Lis M Englund, DsMC, Principal investigator, Fertility Clinic, Dept. of Gynecology and Obstetrics, Holbæk Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03142633
- Sponsor's protocol ID
- SJ-525
- Status last verified
- Mar 2017
- First submitted
- 20 Mar 2017
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Udesen PB, Sorensen AE, Svendsen R, Frisk NLS, Hess AL, Aziz M, Wissing MLM, Englund ALM, Dalgaard LT. Circulating miRNAs in Women with Polycystic Ovary Syndrome: A Longitudinal Cohort Study. Cells. 2023 Mar 23;12(7):983. doi: 10.3390/cells12070983.
PubMed 37048055Udesen 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.
PubMed 30953560
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MicroRNA as Biomarkers for Development of Metabolic Syndrome in Women With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT03142633
- Acronym / sponsor ID
- SJ-525
- Conditions
- Polycystic Ovary Syndrome, Insulin Resistance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Holbaek SygehusUniversity, hospital or other
- Study start
- 9 Sep 2016 (actual)
- Primary completion
- 23 May 2017 (actual)
- Study completion
- 23 May 2017 (actual)
- First posted
- 5 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Local Participants from the PICOLO study, performed at Holbæk Hospital between 2010 and 2013
Key inclusion criteria (2 listed)
- Women between 18 and 40 years when included in the PICOLO study
- PCOS based on the Rotterdam 2003 consensus criteria
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
6 secondary outcomes
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.
Blood Pressure
Time frame: The participants will be examined for 2 hours, at a follow-up visit 5 years after the baseline visit.
Abdominal obesity
Time frame: The participants will be examined for 2 hours, at a follow-up visit 5 years after the baseline visit.
Overweight
Time frame: The participants will be examined for 2 hours, at a follow-up visit 5 years after the baseline visit.
Dyslipidemia
Time frame: The participants will be examined for 2 hours, at a follow-up visit 5 years after the baseline visit.
PCOS status
Time frame: The participants will be examined for 2 hours, at a follow-up visit 5 years after the baseline visit.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
- Derived from this study: PubMed 37048055Udesen PB, Sorensen AE, Svendsen R, Frisk NLS, Hess AL, Aziz M, Wissing MLM, Englund ALM, Dalgaard LT. Circulating miRNAs in Women with Polycystic Ovary Syndrome: A Longitudinal Cohort Study. Cells. 2023 Mar 23;12(7):983. doi: 10.3390/cells12070983.
- Derived from this study: PubMed 30953560Udesen 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.
- Individual participant dataSharing planned: Undecided
Related trials for Polycystic Ovary Syndrome
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Efficacy of Ovarian Drilling Via vNOTES Laparoscopy in Patients With PCOS
PCOS (Polycystic Ovary Syndrome)
RecruitingPhase 1
Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
RecruitingObservational study
The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
Polycystic Ovary Syndrome (PCOS)
Recruiting
The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
PCOS (Polycystic Ovary Syndrome)
Recruiting
Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
Polycystic Ovary Syndrome (PCOS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Lis M Englund, DsMC principal investigator
Fertility Clinic, Dept. of Gynecology and Obstetrics, Holbæk Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polycystic Ovary Syndrome and Insulin Resistance, run by Holbaek Sygehus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03142633, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2019.