Clusterin Level and Polycystic Ovary Syndrome

Clusterin Level Determination and Its Association With Metabolic Syndrome in Patients With Polycystic Ovary Syndrome

Clusterin, a protein involved in metabolic syndrome, insulin resistance, and metabolic disorders associated with inflammation and oxidative stress such as atherosclerosis, Alzheimer's and some malignancies, has elevated levels in metabolic syndrome, PCOS, and the combination of these two groups. Clusterin could be used as an inflammatory marker to predict PCOS and metabolic syndrome.

Study Overview

• Status: Completed
• Conditions: Polycystic Ovary Syndrome; Ovulation Disorder
• Intervention / Treatment: Diagnostic test: Clusterin level

Detailed Description

The study included 118 women diagnosed with PCOS according to the Rotterdam criteria and 62 age-matched healthy women without cardiovascular risk factors. The patients diagnosed with PCOS were also classified into phenotypes. No interventional examination was requested for patients A, B, C, and D, except for hormonal tests and blood collection for Human Clusterin. The demographic and clinical characteristics of all patients were compared, with the primary outcome being blood Clusterin levels. The secondary outcomes are blood Clusterin levels in women with and without metabolic syndrome in addition to PCOS, the relationship between PCOS phenotypes and Clusterin levels, and the relationship between Clusterin levels and clinical and laboratory parameters.

• Study Type: Observational
• Enrollment (Actual): 118

Contacts and Locations

Study Locations

• Turkey
  • Bursa, Turkey, 16110
    • Nefise nazlı Yenigül

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

118 women who were diagnosed with polycystic ovary syndrome (PCOS) according to the Rotterdam criteria, as well as 62 healthy women of the same age without any cardiovascular risk factors. Patients diagnosed with PCOS were classified into four phenotypes: A, B, C, and D. Phenotype A was characterized by metabolic syndrome, phenotype B was characterized by the absence of metabolic syndrome, phenotype C was characterized by hyperandrogenism, and phenotype D was characterized by the absence of hyperandrogenism.

Description

Inclusion Criteria:

• Women aged between 18 and 45,
• natural bilateral ovaries and no functional cysts on transvaginal ultrasound.

Exclusion Criteria:

• who have hyperandrogenism/hyperandrogenemia
• who have non-classical congenital adrenal hyperplasia (17 OHP value >2 nmol/L)
• who have thyroid disease (TSH >5 mlU/L),
• women with hyperprolactinemia (Prolactin>30 mlU/mL)
• patients taking hormonal drugs or ovulation induction agents.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Phenotype A; Phenotype A was characterized by metabolic syndrome	Diagnostic test: Clusterin level; Clusterin plays a role in inflammation and oxidative stress processes such as metabolic syndrome, insulin resistance, and atherosclerosis
Phenotype B; phenotype B was characterized by the absence of metabolic syndrome	Diagnostic test: Clusterin level; Clusterin plays a role in inflammation and oxidative stress processes such as metabolic syndrome, insulin resistance, and atherosclerosis
Phenotype C; phenotype C was characterized by hyperandrogenism	Diagnostic test: Clusterin level; Clusterin plays a role in inflammation and oxidative stress processes such as metabolic syndrome, insulin resistance, and atherosclerosis
Phenotype D; phenotype D was characterized by the absence of hyperandrogenism	Diagnostic test: Clusterin level; Clusterin plays a role in inflammation and oxidative stress processes such as metabolic syndrome, insulin resistance, and atherosclerosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CLusterin level	primary outcome is the measurement of blood Clusterin (Apolipoprotein J) levels in healthy women with and without PCOS	7 months

Collaborators and Investigators

• Sponsor: Sanliurfa Mehmet Akif Inan Education and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): November 1, 2021
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: September 16, 2024
• First Submitted That Met QC Criteria: September 16, 2024
• First Posted (Estimated): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 16, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: metabolic syndrome; clusterin
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Disease; 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; Syndrome
• Other Study ID Numbers: 2011-KAEK-25 2021/02-06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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