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

February 27, 2026 updated by: Uşak University
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.

Study Overview

Status

Completed

Conditions

Detailed Description

Polycystic ovary syndrome (PCOS) is one of the endocrinological diseases that affects 5-20% of women of reproductive age; It is characterized by oligoanovulation, clinical or biochemical hyperandrogenemia, and the appearance of polycystic ovaries. The diagnosis of this syndrome is made according to the revised 2003 Rotterdam criteria; These criteria; 1) Oligo-anovulation, 2) Clinical and/or biochemical hyperandrogenism findings, 3) polycystic ovary (PCO) appearance in the ovaries. For diagnosis, it is sufficient to have two of these criteria and the absence of another disease that causes this.

Polycystic ovary syndrome; Metabolic disorders such as insulin resistance, dyslipidemia, glucose intolerance, hypertension and obesity are often accompanied, and increased inflammation is the main characteristic of this syndrome. While the presence or absence of PCOS was important until recently, recent studies have shown that metabolic changes and inflammation occur at different degrees in different phenotypesof PCOS. Therefore, PCOS cases are divided into 4 phenotypes. These; phenotypes A has hyperandrogenemia + oligoanovulation + PCO appearance on ultrasonography (USG), phenotypes B has hyperandrogenemia + oligoanovulation, phenotypes C has hyperandrogenemia + PCO appearance on USG, and phenotypes D has oligoanovulation + PCO appearance on USG. As the phenotypesnumber of polycystic ovary syndrome decreases, the severity and frequency of metabolic disorders and inflammation accompanying polycystic ovary syndrome increase.

Polycystic ovary syndrome is associated with both subclinical low-grade inflammation, which may cause deterioration in renal functions in the long term, and metabolic disorders such as insulin resistance, dyslipidemia, glucose intolerance, hypertension and obesity, which may bring about glomerular filtration rate (GFR) changes. Additionally, increased urinary albumin/creatinine ratio (ACR) is a result of vascular leak and endothelial damage and is associated with increased cardiovascular risk. It has been suggested that the albumin-creatinine ratio in urine is increased in patients with polycystic ovary syndrome, and to detect the increased cardiovascular risk in patients with PCOS, the albumin/creatinine ratio in spot urine should be measured in these patients.

In this study, the investigators used different PCOS phenotypes; The investigators aimed to investigate whether there is a difference between GFR (eGFR) calculated from blood creatinine level and urinary ACR calculated from morning spot urine. Although there are studies on the renal functions of patients with PCOS in the literature review, as mentioned above, the number of studies evaluating renal complications in PCOS phenotypes is limited. The investigators aimed to contribute to the knowledge in this field with this study.

Study Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

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.

-

Description

Inclusion Criteria:

  1. 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,
  2. Female patients between the ages of 18-35,
  3. Patients without known cancer, liver or kidney failure,
  4. Patients who do not take drugs, ACEIs and ARBs.
  5. Female patients without active infection will be included. -

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urine albumin/creatinine ratio
Time Frame: Eight months
Urinary albumin-to-creatinine ratio (ACR) measured in morning spot urine samples (expressed in mg/g).
Eight months
glomerular filtration rate
Time Frame: Eight months
Estimated glomerular filtration rate (eGFR) calculated from serum creatinine levels (expressed in mL/min/1.73 m²).
Eight months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uşak University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2022

Primary Completion (Actual)

September 1, 2022

Study Completion (Actual)

July 20, 2023

Study Registration Dates

First Submitted

July 2, 2024

First Submitted That Met QC Criteria

February 27, 2026

First Posted (Actual)

March 2, 2026

Study Record Updates

Last Update Posted (Actual)

March 2, 2026

Last Update Submitted That Met QC Criteria

February 27, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Usakpcos3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Polycystic Ovary Syndrome

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Finland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe