Activity of Chronic Inflammation in PCOS

Evaluation of the Activity of Chronic Inflammation and Its Impact on Metabolic and Hormonal Parameters in Various PCOS Phenotypes

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.

Study Overview

• Status: Recruiting
• Conditions: Polycystic Ovary Syndrome
• Intervention / Treatment: 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

Detailed Description

The study population will be characterized in terms of demographic (age, BMI), gynaecological (cycle length, menstrual pain, abnormal uterine bleeding) and obstetrics (pregnancies, childbirth, miscarriages) data. PCOS syndrome (and its phenotypes: A, B, C, D) will be recognized by the Rotterdam criteria. During hospitalization, blood samples will be collected for scheduled analyses (20 ml of blood in total).

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Iwona Gawron, PhD, MD; Phone Number: +48 124248570; Email: iwona.gawron@uj.edu.pl
• Study Contact Backup: Name: Robert Jach, Prof.; Phone Number: +48 124248571; Email: jach@cm-uk.krakow.pl

Study Locations

• Poland
  • Krakow, Poland, 31-501
    • Recruiting
    • Jagiellonian University Medical College
    • Contact: Iwona Gawron, PhD, MD; Phone Number: +48 124248570; Email: iwona.gawron@uj.edu.pl
    • Contact: Robert Jach, Prof.; Phone Number: +48 124248571; Email: jach@uj-cm.krakow.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: N/A

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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; 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; 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 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; 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; 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; 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 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; 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; 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; 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 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; 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; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between the HOMA-IR value and the parameters of inflammation - leukocytosis in the four PCOS phenotypes	Evaluation of the correlation between the HOMA-IR value and inflammatory parameters: leukocyte count (n/µL)	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	Evaluation of the correlation between the HOMA-IR value and inflammatory parameters: CRP (mg/l)	up to 3 months
Correlation between the HOMA-IR value and the parameters of inflammation - il-1 in the four PCOS phenotypes	Evaluation of the correlation between the HOMA-IR and inflammatory parameters: il-1 (pg/ml)	up to 3 months
Correlation between the HOMA-IR value and the parameters of inflammation - il-6 in the four PCOS phenotypes	Evaluation of the correlation between HOMA-IR value and inflammatory parameters: il-6 (pg/ml)	up to 3 months
Correlation between the concentration of HOMA-IR and the parameters of inflammation - il-10 in in the four PCOS phenotypes	Evaluation of the correlation between the concentration of HOMA-IR and inflammatory parameters: il-10 (pg/ml)	up to 3 months
Correlation between the HOMA-IR value and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes	Evaluation of the correlation between the HOMA-IR value and inflammatory parameters: TNF-alpha (pg/ml)	up to 3 months
Correlation between the body mass index (BMI) value and the parameters of inflammation - leukocytosis in the four PCOS phenotypes	Evaluation of the correlation between the BMI value and inflammatory parameters: leukocyte count (n/µL)	up to 3 months
Correlation between the BMI value and the parameters of inflammation - CRP in the four PCOS phenotypes	Evaluation of the correlation between the BMI value and inflammatory parameters: CRP (mg/l)	up to 3 months
Correlation between the BMI value and the parameters of inflammation - il-1 in the four PCOS phenotypes	Evaluation of the correlation between the BMI and inflammatory parameters: il-1 (pg/ml)	up to 3 months
Correlation between the BMI value and the parameters of inflammation - il-6 in the four PCOS phenotypes	Evaluation of the correlation between BMI value and inflammatory parameters: il-6 (pg/ml)	up to 3 months
Correlation between the concentration of BMI and the parameters of inflammation - il-10 in in the four PCOS phenotypes	Evaluation of the correlation between BMI value and inflammatory parameters: il-10 (pg/ml)	up to 3 months
Correlation between the BMI value and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes	Evaluation of the correlation between the BMI value and inflammatory parameters: TNF-alpha (pg/ml)	up to 3 months
Correlation between the value of aspartate aminotransferase (AST) concentration and the parameters of inflammation - leukocytosis in the four PCOS phenotypes	Evaluation of the correlation between AST concentration (U/l) and inflammatory parameters: leukocyte count (n/µL)	up to 3 months
Correlation between the value of AST concentration and the parameters of inflammation - CRP in the four PCOS phenotypes	Evaluation of the correlation between AST concentration (U/l) and inflammatory parameters: CRP (mg/l)	up to 3 months
Correlation between the value of AST concentration and the parameters of inflammation - il-1 in the four PCOS phenotypes	Evaluation of the correlation between AST concentration (U/l) and inflammatory parameters: il-1 (pg/ml)	up to 3 months
Correlation between the value of AST concentration and the parameters of inflammation - il-6 in the four PCOS phenotypes	Evaluation of the correlation between AST concentration (U/l) and inflammatory parameters: il-6 (pg/ml)	up to 3 months
Correlation between the value of AST concentration and the parameters of inflammation - il-10 in in the four PCOS phenotypes	Evaluation of the correlation between AST concentration (U/l) and inflammatory parameters: il-10 (pg/ml)	up to 3 months
Correlation between the value of AST concentration and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes	Evaluation of the correlation between AST concentration (U/l) and inflammatory parameters: TNF-alpha (pg/ml)	up to 3 months
Correlation between the value of alanine aminotransferase (ALT) concentration and the parameters of inflammation - leukocytosis in the four PCOS phenotypes	Evaluation of the correlation between ALT concentration (U/l) and inflammatory parameters: leukocyte count (n/µL)	up to 3 months
Correlation between the value of ALT concentration and the parameters of inflammation - CRP in the four PCOS phenotypes	Evaluation of the correlation between ALT concentration (U/l) and inflammatory parameters: CRP (mg/l)	up to 3 months
Correlation between the value of ALT concentration and the parameters of inflammation - il-1 in the four PCOS phenotypes	Evaluation of the correlation between ALT concentration (U/l) and inflammatory parameters: il-1 (pg/ml)	up to 3 months
Correlation between the value of ALT concentration and the parameters of inflammation - il-6 in the four PCOS phenotypes	Evaluation of the correlation between ALT concentration (U/l) and inflammatory parameters: il-6 (pg/ml)	up to 3 months
Correlation between the value of ALT concentration and the parameters of inflammation - il-10 in in the four PCOS phenotypes	Evaluation of the correlation between ALT concentration (U/l) and inflammatory parameters: il-10 (pg/ml)	up to 3 months
Correlation between the value of ALT concentration and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes	Evaluation of the correlation between ALT concentration (U/l) and inflammatory parameters: TNF-alpha (pg/ml)	up to 3 months
Correlation between the value of total bilirubin concentration and the parameters of inflammation - leukocytosis in the four PCOS phenotypes	Evaluation of the correlation between total bilirubin concentration (mg/dl) and inflammatory parameters: leukocyte count (n/µL)	up to 3 months
Correlation between the value of total bilirubin concentration and the parameters of inflammation - CRP in the four PCOS phenotypes	Evaluation of the correlation between total bilirubin concentration (mg/dl) and inflammatory parameters: CRP (mg/l)	up to 3 months
Correlation between the value of total bilirubin concentration and the parameters of inflammation - il-1 in the four PCOS phenotypes	Evaluation of the correlation between total bilirubin concentration (mg/dl) and inflammatory parameters: il-1 (pg/ml)	up to 3 months
Correlation between the value of total bilirubin concentration and the parameters of inflammation - il-6 in the four PCOS phenotypes	Evaluation of the correlation between total bilirubin concentration (mg/dl) and inflammatory parameters: il-6 (pg/ml)	up to 3 months
Correlation between the value of total bilirubin concentration and the parameters of inflammation - il-10 in in the four PCOS phenotypes	Evaluation of the correlation between total bilirubin concentration (mg/dl) and inflammatory parameters: il-10 (pg/ml)	up to 3 months
Correlation between the value of total bilirubin concentration and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes	Evaluation of the correlation between total bilirubin concentration (mg/dl) and inflammatory parameters: TNF-alpha (pg/ml)	up to 3 months
Correlation between the value of total cholesterol concentration and the parameters of inflammation - leukocytosis in the four PCOS phenotypes	Evaluation of the correlation between total cholesterol concentration (mg/dl) and inflammatory parameters: leukocyte count (n/µL)	up to 3 months
Correlation between the value of total cholesterol concentration and the parameters of inflammation - CRP in the four PCOS phenotypes	Evaluation of the correlation between total cholesterol concentration (mg/dl) and inflammatory parameters: CRP (mg/l)	up to 3 months
Correlation between the value of total cholesterol concentration and the parameters of inflammation - il-1 in the four PCOS phenotypes	Evaluation of the correlation between total cholesterol concentration (mg/dl) and inflammatory parameters: il-1 (pg/ml)	up to 3 months
Correlation between the value of total cholesterol concentration and the parameters of inflammation - il-6 in the four PCOS phenotypes	Evaluation of the correlation between total cholesterol concentration (mg/dl) and inflammatory parameters: il-6 (pg/ml)	up to 3 months
Correlation between the value of total cholesterol concentration and the parameters of inflammation - il-10 in in the four PCOS phenotypes	Evaluation of the correlation between total cholesterol concentration (mg/dl) and inflammatory parameters: il-10 (pg/ml)	up to 3 months
Correlation between the value of total cholesterol concentration and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes	Evaluation of the correlation between total cholesterol concentration (mg/dl) and inflammatory parameters: TNF-alpha (pg/ml)	up to 3 months
Correlation between the value of triglycerides concentration and the parameters of inflammation - leukocytosis in the four PCOS phenotypes	Evaluation of the correlation between triglycerides concentration (mg/dl) and inflammatory parameters: leukocyte count (n/µL)	up to 3 months
Correlation between the value of triglycerides concentration and the parameters of inflammation - CRP in the four PCOS phenotypes	Evaluation of the correlation between triglycerides concentration (mg/dl) and inflammatory parameters: CRP (mg/l)	up to 3 months
Correlation between the value of triglycerides concentration and the parameters of inflammation - il-1 in the four PCOS phenotypes	Evaluation of the correlation between triglycerides concentration (mg/dl) and inflammatory parameters: il-1 (pg/ml)	up to 3 months
Correlation between the value of triglycerides concentration and the parameters of inflammation - il-6 in the four PCOS phenotypes	Evaluation of the correlation between triglycerides concentration (mg/dl) and inflammatory parameters: il-6 (pg/ml)	up to 3 months
Correlation between the value of triglycerides concentration and the parameters of inflammation - il-10 in in the four PCOS phenotypes	Evaluation of the correlation between triglycerides concentration (mg/dl) and inflammatory parameters: il-10 (pg/ml)	up to 3 months
Correlation between the value of triglycerides concentration and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes	Evaluation of the correlation between triglycerides concentration (mg/dl) and inflammatory parameters: TNF-alpha (pg/ml)	up to 3 months
Correlation between the value of Anti-Müllerian hormone (AMH) concentration and the parameters of inflammation - leukocytosis in the four PCOS phenotypes	Evaluation of the correlation between AMH concentration (pmol/l) and inflammatory parameters: leukocyte count (n/µL)	up to 3 months
Correlation between the value of AMH concentration and the parameters of inflammation - CRP in the four PCOS phenotypes	Evaluation of the correlation between AMH concentration (pmol/l) and inflammatory parameters: CRP (mg/l)	up to 3 months
Correlation between the value of AMH concentration and the parameters of inflammation - il-1 in the four PCOS phenotypes	Evaluation of the correlation between AMH concentration (pmol/l) and inflammatory parameters: il-1 (pg/ml)	up to 3 months
Correlation between the value of AMH concentration and the parameters of inflammation - il-6 in the four PCOS phenotypes	Evaluation of the correlation between AMH concentration (pmol/l) and inflammatory parameters: il-6 (pg/ml)	up to 3 months
Correlation between the value of AMH concentration and the parameters of inflammation - il-10 in in the four PCOS phenotypes	Evaluation of the correlation between AMH concentration (pmol/l) and inflammatory parameters: il-10 (pg/ml)	up to 3 months
Correlation between the value of AMH concentration and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes	Evaluation of the correlation between AMH concentration (pmol/l) and inflammatory parameters: TNF-alpha (pg/ml)	up to 3 months

Collaborators and Investigators

• Sponsor: Jagiellonian University
• Investigators: Study Chair: Kazimierz Pitynski, Prof., Jagiellonian University

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2024
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: March 2, 2024
• First Submitted That Met QC Criteria: March 2, 2024
• First Posted (Actual): March 8, 2024

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: March 2, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: chronic inflammation; ovarian reserve; metabolic disorders; PCOS phenotypes
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Polycystic Ovary Syndrome; Inflammation
• Other Study ID Numbers: 1072.6120.292.2022-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No