Clusterin Level and Polycystic Ovary Syndrome

NCT06601725 | Completed

• 1 other identifier: 2011-KAEK-25 2021/02-06
• Study Type: observational
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Polycystic Ovary Syndrome; Ovulation Disorder

Keywords

clusterin; metabolic syndrome

Outcome Measures

Primary Outcomes (1)

• CLusterin level

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

  7 months

Study Arms (4)

Phenotype A

Phenotype A was characterized by metabolic syndrome

Diagnostic Test: Clusterin level

Phenotype B

phenotype B was characterized by the absence of metabolic syndrome

Diagnostic Test: Clusterin level

Phenotype C

phenotype C was characterized by hyperandrogenism

Diagnostic Test: Clusterin level

Phenotype D

phenotype D was characterized by the absence of hyperandrogenism

Diagnostic Test: Clusterin level

Interventions

Clusterin level DIAGNOSTIC_TEST

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

Phenotype A; Phenotype B; Phenotype C; Phenotype D

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanliurfa Mehmet Akif Inan Education and Research Hospital: lead

Study Sites (1)

Nefise Nazlı Yenigül

Bursa, 16110, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples were collected after at least 12 hours of fasting, 5 mL from the antecubital vein, with the patient in a sitting position using a vacutainer. The samples were placed in a gel tube (biochemistry tube) and centrifuged at 4000 rpm for 5 minutes. Storage conditions were ensured. The samples were stored in a cabinet at -80 degrees Celsius in the genetics laboratory. Clusterin levels were measured using the BT LAB Human Clusterin (CLU) ELISA kit, with min-max values of 0.5-300 ng/ml.

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Metabolic Syndrome

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; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D. Assistant Professor Department of Obstetrics and Gynecology

Study Record Dates

• First Submitted: September 16, 2024
• First Posted: September 19, 2024
• Study Start: April 1, 2021
• Primary Completion: November 1, 2021
• Study Completion: December 1, 2021
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)