Activity of Chronic Inflammation in PCOS

Polycystic Ovary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06300593
• Other study ID #: 1072.6120.292.2022-1
• Status: Recruiting
• Start date: January 15, 2024
• Est. completion date: June 30, 2024

Study information

• Verified date: March 2024
• Source: Jagiellonian University
• Contact: Iwona Gawron, PhD, MD
• Phone: +48 124248570
• Email: iwona.gawron[@]uj.edu.pl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 30, 2024
• Est. primary completion date: June 1, 2024
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Polycystic Ovary Syndrome

Intervention

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
• 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

Locations

Country	Name	City	State
Poland	Jagiellonian University Medical College	Krakow

Sponsors (1)

Lead Sponsor	Collaborator
Jagiellonian University

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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