Urine Albumin/Creatinine Ratio and Renal Function Differences in Phenotypes of Polycystic Ovary Syndrome.

NCT07441811 | Completed

• 1 other identifier: Usakpcos3
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Since there are different metabolic effects in different phenotypes of polycystic ovary syndrome (PCOS); in this study; the investigators aimed to investigate whether there is a difference between glomerular filtration rate (eGFR) and urine albumin/creatinine ratio (ACR) levels in different PCOS phenotypes and compare healthy controls.

Conditions

Polycystic Ovary Syndrome; Urine Albumin \(UAlb\); Urine Creatinine \(UCr\); Glomerular Filtration Rate

Keywords

Polycystic ovary syndrome; PCOS Phenotypes; Urine albumin/creatinine ratio; Glomerular Filtration Rate

Outcome Measures

Primary Outcomes (2)

• Urine albumin/creatinine ratio

  Urinary albumin-to-creatinine ratio (ACR) measured in morning spot urine samples (expressed in mg/g).

  Eight months

• glomerular filtration rate

  Estimated glomerular filtration rate (eGFR) calculated from serum creatinine levels (expressed in mL/min/1.73 m²).

  Eight months

Study Arms (5)

Controls

Healthy controls between 18-35 years.

PCOS Phenotype A

Hyperandrogenemia+oligoanovulation+PCO appearance on USG.

PCOS Phenotype B

Hyperandrogenemia+oligoanovulation

PCOS Phenotype C

Hyperandrogenemia+PCO appearance on USG.

PCOS Phenotype D

Oligoanovulation+PCO appearance on USG.

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Woman aged between 18 and 35 years, age-matched between groups, diagnosed with PCOS and without cancer diagnosis, liver and kidney failure, not taking medications like ACEI and ARB\'s, and without active infection. \-

You may qualify if:

• Patients who applied for reasons such as hair growth, acne, menstrual irregularity or infertility and were diagnosed with PCOS after examination, biochemical, hormonal and sonographic tests,
• Female patients between the ages of 18-35,
• Patients without known cancer, liver or kidney failure,
• Patients who do not take drugs, ACEIs and ARBs.
• Female patients without active infection will be included. -

You may not qualify if:

• Female patients \<18 years of age and \>35 years of age,
• Patients with known cancer, liver and kidney failure,
• Patients taking drugs, ACEIs and ARBs,
• Patients with active infection will not be included in the study. -

Sponsors & Collaborators

• Uşak University: lead

Study Sites (1)

Usak Egitim Ve Araştırma Hastanesi

Uşak, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

After 8-12 hours of fasting, 2-3 ml blood will be taken to measure serum creatinine level, and will be frozen at -70 °C. In addition, to calculate ACR, spot urine will be collected in the morning and microalbumin and creatinine levels will be measured in this urine and ACR will be calculated.

MeSH Terms

Conditions

Polycystic Ovary 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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 16 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: March 2, 2026
• Study Start: April 1, 2022
• Primary Completion: September 1, 2022
• Study Completion: July 20, 2023
• Last Updated: March 2, 2026

Record last verified: 2026-02

Locations

TU (1)