Clinical trial · Observational
MicroRNA as Biomarkers for Development of Metabolic Syndrome in Women With Polycystic Ovary Syndrome
NCT03142633CI-TRIAL-00037334completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Insulin Resistance | — | UNRESOLVED | — |
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Women with Polycystic Ovary Syndrome
- description
- 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 outcomes (1)
- 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.
- description
- 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 (6)
- measure
- Insulin Resistance and Type 2 Diabetes
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
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.
References
Publications (2)
- DERIVEDUdesen 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. PMID 37048055
- DERIVEDUdesen 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. PMID 30953560