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CompletedNCT07441811Updated Mar 2, 2026

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

An observational study in Polycystic Ovary Syndrome, Urine Albumin \(UAlb\) and Urine Creatinine \(UCr\), sponsored by Uşak University. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2026-03-02.

Sponsored by Uşak University · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
300
Ages
18 Years to 35 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

In context

Polycystic Ovary Syndrome

944 studies on the registry are indexed under Polycystic Ovary Syndrome; 174 are open to participants now.

This study's enrollment of 300 is above the median of 118 across 223 observational studies indexed under Polycystic Ovary Syndrome.

Browse Polycystic Ovary Syndrome studies →

Lead sponsor

Uşak University is the lead sponsor of 78 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Female
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.

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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

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. -
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
300 participants (actual)
Target follow-up
16 Months
Patient registry
Yes
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. Urine albumin/creatinine ratio

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

    Time frame: Eight months

  2. glomerular filtration rate

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

    Time frame: Eight months

07

Study locations

1 site
  • Usak Egitim Ve Araştırma Hastanesi
    Uşak, Turkey (Türkiye)
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07441811
Lead sponsor
Uşak University
Responsible party
Sponsor
First posted
Mar 2, 2026
Start date
Apr 1, 2022
Primary completion
Sep 1, 2022
Completion
Jul 20, 2023
Last update
Mar 2, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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