Investigating inflammatory markers in women with PCOS
Assessment of the Concentrations of Pro- and Anti-inflammatory Cytokines and Their Association With the Metabolic Profile of Women With PCOS
This study is testing the levels of certain inflammatory markers in women with polycystic ovary syndrome (PCOS) to see how they compare to women without PCOS and to understand their connection to insulin resistance.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Jagiellonian University Academic / other |
| Locations | 1 site (Krakow) |
| Trial ID | NCT06793085 on ClinicalTrials.gov |
What this trial studies
This observational study aims to measure and compare the levels of pro-inflammatory cytokines (IL-6, TNF-α, IL-18) and the anti-inflammatory cytokine (IL-4) in women with polycystic ovary syndrome (PCOS) and insulin resistance, women with PCOS without carbohydrate metabolism disorders, and a control group of women without PCOS. The study will utilize immunoenzymatic methods (ELISA) and a biochemical analyzer to assess these cytokine concentrations. By identifying the balance of inflammatory markers, the research seeks to uncover potential links to insulin resistance and related health complications in women of reproductive age.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18-45 years, specifically those with a diagnosis of PCOS.
Not a fit: Patients who have had at least one ovary removed, or those with treated diabetes, metabolic diseases, autoimmune diseases, or autoinflammatory diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and identification of biomarkers for insulin resistance in women with PCOS, potentially guiding better treatment strategies.
How similar studies have performed: While there have been studies investigating inflammatory markers in PCOS, this specific approach focusing on the balance of pro- and anti-inflammatory cytokines in relation to insulin resistance is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * women aged 18-45 years Exclusion Criteria: * previous removal of at least one ovary * treated diabetes of any type * diagnosed and treated metabolic diseases * diagnosed and treated autoimmune diseases * diagnosed and treated autoinflammatory diseases
Where this trial is running
Krakow
- Jagiellonian University — Krakow, Poland (Recruiting)
Study contacts
- Study coordinator: Iwona Gawron, Ph.D., M.D.
- Email: iwona.gawron@uj.edu.pl
- Phone: +48 124248570
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.