Activity of Chronic Inflammation in PCOS

NCT06300593 | Completed DMC

• 1 other identifier: 1072.6120.292.2022-1
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic inflammation in polycystic ovary syndrome (PCOS) may be the result of dysregulation of cytokine production (due to insulin resistance, excess visceral fat and hyperandrogenemia), i.e., overproduction of pro-inflammatory factors (e.g. TNF, IL-1, IL-6) in relation to anti-inflammatory ones (IL-10). This condition may be an important link between obesity and insulin resistance, which is crucial in the etiopathogenesis of the syndrome. However, it is not known whether it results from the tendency to accumulate adipose tissue or is a feature of the syndrome itself. There is no data indicating the relationship between chronic inflammation and the severity of metabolic disorders and the value of ovarian reserve in women with various PCOS phenotypes.

Conditions

Polycystic Ovary Syndrome

Keywords

PCOS phenotypes; chronic inflammation; metabolic disorders; ovarian reserve

Outcome Measures

Primary Outcomes (6)

• Values of inflammation parameters - leukocytosis in peripheral blood in the four PCOS phenotypes

  Measurement and comparison of leukocyte count (n/µL) in peripheral blood in the four PCOS phenotypes

  up to 3 months

• Values of inflammation parameters - C-reactive protein (CRP) in peripheral blood in the four PCOS phenotypes

  Measurement and comparison of concentrations of CRP (mg/l) in peripheral blood in the four PCOS phenotypes

  up to 3 months

• Values of inflammation parameters - IL-1 in peripheral blood in the four PCOS phenotypes

  Measurement and comparison of concentrations of IL-1 (pg/ml) in peripheral blood in the four PCOS phenotypes

  up to 3 months

• Values of inflammation parameters - IL-6 in peripheral blood in the four PCOS phenotypes

  Measurement and comparison of concentrations of IL-6 (pg/ml) in peripheral blood in the four PCOS phenotypes

  up to 3 months

• Values of inflammation parameters - IL-10 in peripheral blood in the four PCOS phenotypes

  Measurement and comparison of concentrations of IL-10 (pg/ml) in peripheral blood in the four PCOS phenotypes

  up to 3 months

• Values of inflammation parameters - TNF-alpha in peripheral blood in the four PCOS phenotypes

  Measurement and comparison of concentrations of TNF-alpha (pg/ml) in peripheral blood in the four PCOS phenotypes

  up to 3 months

Secondary Outcomes (48)

• Correlation between the HOMA-IR value and the parameters of inflammation - leukocytosis in the four PCOS phenotypes

  up to 3 months

• Correlation between the homeostatic model assessment for insulin resistance (HOMA-IR) value and the parameters of inflammation - CRP in the four PCOS phenotypes

  up to 3 months

• Correlation between the HOMA-IR value and the parameters of inflammation - il-1 in the four PCOS phenotypes

  up to 3 months

• Correlation between the HOMA-IR value and the parameters of inflammation - il-6 in the four PCOS phenotypes

  up to 3 months

• Correlation between the concentration of HOMA-IR and the parameters of inflammation - il-10 in in the four PCOS phenotypes

  up to 3 months

Study Arms (4)

PCOS phenotype A

clinical and/or biochemical hyperandrogenism (HA) + ovulatory dysfunction (OD) + polycystic ovarian morphology (PCOM)

Diagnostic Test: Measurement and comparison of leucocytosis and concentrations of C-reactive protein (CRP), interleukin-1 (IL-1), IL-6, IL-10, Tumor Necrosis Factor (TNF-alpha) in PCOS phenotypes A, B, C and D; Diagnostic Test: Evaluation of the correlation of serum concentrations of selected inflammatory markers (leucocytosis, CRP, IL-1, IL-6, IL-10, TNF-alpha) with metabolic and hormonal parameters

PCOS phenotype B

HA + OD

Diagnostic Test: Measurement and comparison of leucocytosis and concentrations of C-reactive protein (CRP), interleukin-1 (IL-1), IL-6, IL-10, Tumor Necrosis Factor (TNF-alpha) in PCOS phenotypes A, B, C and D; Diagnostic Test: Evaluation of the correlation of serum concentrations of selected inflammatory markers (leucocytosis, CRP, IL-1, IL-6, IL-10, TNF-alpha) with metabolic and hormonal parameters

PCOS phenotype C

HA + PCOM

Diagnostic Test: Measurement and comparison of leucocytosis and concentrations of C-reactive protein (CRP), interleukin-1 (IL-1), IL-6, IL-10, Tumor Necrosis Factor (TNF-alpha) in PCOS phenotypes A, B, C and D; Diagnostic Test: Evaluation of the correlation of serum concentrations of selected inflammatory markers (leucocytosis, CRP, IL-1, IL-6, IL-10, TNF-alpha) with metabolic and hormonal parameters

PCOS phenotype D

OD + PCOM

Diagnostic Test: Measurement and comparison of leucocytosis and concentrations of C-reactive protein (CRP), interleukin-1 (IL-1), IL-6, IL-10, Tumor Necrosis Factor (TNF-alpha) in PCOS phenotypes A, B, C and D; Diagnostic Test: Evaluation of the correlation of serum concentrations of selected inflammatory markers (leucocytosis, CRP, IL-1, IL-6, IL-10, TNF-alpha) with metabolic and hormonal parameters

Interventions

Measurement and comparison of leucocytosis and concentrations of C-reactive protein (CRP), interleukin-1 (IL-1), IL-6, IL-10, Tumor Necrosis Factor (TNF-alpha) in PCOS phenotypes A, B, C and D DIAGNOSTIC_TEST

A venous blood sample of approximately 10 ml will be collected in the morning after 8 hours of fasting to determine and compare the above parameters of peripheral blood in the four study arms

PCOS phenotype A; PCOS phenotype B; PCOS phenotype C; PCOS phenotype D

Evaluation of the correlation of serum concentrations of selected inflammatory markers (leucocytosis, CRP, IL-1, IL-6, IL-10, TNF-alpha) with metabolic and hormonal parameters DIAGNOSTIC_TEST

A venous blood sample of approximately 10 ml will be collected in the morning after 8 hours of fasting to test the above correlations in the four study arms

PCOS phenotype A; PCOS phenotype B; PCOS phenotype C; PCOS phenotype D

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women aged 18-45, treated at the University Hospital in Krakow, diagnosed with PCOS confirmed by the Rotterdam criteria, phenotypes A, B, C, D, without other metabolic and endocrine diseases.

You may qualify if:

• age 18-45 years
• PCOS syndrome confirmed by the Rotterdam criteria

You may not qualify if:

• absence of at least one ovary
• diagnosed and/or treated other metabolic disease
• diagnosed and/or treated other endocrine disease

Sponsors & Collaborators

• Jagiellonian University: lead

Study Sites (1)

Jagiellonian University Medical College

Krakow, 31-501, Poland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood serum specimens

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Metabolic Diseases

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Nutritional and Metabolic Diseases

Study Officials

• Kazimierz Pitynski, Prof.

  Jagiellonian University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 2, 2024
• First Posted: March 8, 2024
• Study Start: January 15, 2024
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: July 30, 2024

Record last verified: 2024-07

Locations

PL (1)