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OpenTrials
Completed

NCT Number: NCT06601725

Clusterin Level and 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.

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Glucose Metabolism Disorders Gonadal Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Neoplasms Nutritional and Metabolic Diseases Ovarian Cysts Ovarian Diseases Ovulation Disorder Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Nefise Nazlı Yenigül

Bursa, 16110, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clusterin level

Diagnostic Test

Clusterin plays a role in inflammation and oxidative stress processes such as metabolic syndrome, insulin resistance, and atherosclerosis

Primary outcomes

  1. CLusterin level

    Time frame: 7 months

    primary outcome is the measurement of blood Clusterin (Apolipoprotein J) levels in healthy women with and without PCOS

Sponsors and collaborators

Lead sponsor

Sanliurfa Mehmet Akif Inan Education and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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