- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06342180
Metabolic Differences Between Subtypes of Polycystic Ovary Syndrome
Serum Uric Acid Levels in Polycystic Ovary Syndrome Subtypes.
Study Overview
Status
Intervention / Treatment
Detailed Description
The final breakdown product of adenosine and guanosine-based purines formed as a result of the breakdown of nucleic acids is uric acid (UA). Uric acid has many beneficial and harmful properties for humans. One of the most important benefits of uric acid is that it can act as an antioxidant and is perhaps one of the most important antioxidants in plasma. However, this hypothesis is completely opposite to the hypothesis advocating an increase in the incidence of hyperuricemia and cardiovascular events. There are also experimental studies showing that UA, which has an antioxidant effect in the extracellular fluid, has harmful effects when it enters the cell. Uric acid can contribute to molecular endothelial dysfunction, oxidative stress and the formation of many oxygen radicals, disruption of the vasodilation mechanism, and increased inflammation. A correlation has been found between insulin resistance and serum UA level in patients with metabolic syndrome. It has been reported in some studies that hyperuricemia can be considered as an indicator of insulin resistance in these patients. At the same time, many studies have reported that both insulin resistance and hyperuricemia increase cardiovascular risk. In a study, it was stated that every 1 mg/dL increase in serum UA level in women increased the risk of ischemic heart disease by 12%.
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. This syndrome is diagnosed according to the revised 2003 Rotterdan 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 not have 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 one of the main characteristics 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 subtypes of PCOS. Therefore, PCOS cases are divided into 4 subtypes. These; Subtype 1 has hyperandrogenemia + oligoanovulation + PCO appearance on ultrasonography (USG), Subtype 2 has hyperandrogenemia + oligoanovulation, Subtype 3 has hyperandrogenemia + PCO appearance on USG, and Subtype 4 has oligoanovulation + PCO appearance on USG. As the subtype number of polycystic ovary syndrome decreases, the severity and frequency of metabolic disorders and inflammation accompanying polycystic ovary syndrome increase.
Hyperuricemia is one of the common metabolic disorders in patients with PCOS. Prevalence studies have shown that the frequency of hyperuricemia in patients with PCOS is approximately 25%, 3 times higher than in controls. However, these studies were conducted in the general PCOS patient group, and patients with different subtypes were not evaluated.
Since there are different metabolic effects in different subtypes of polycystic ovary syndrome; In this study we aimed to investigate whether there is a difference between serum UA levels in different PCOS subtypes. Studies investigating UA levels in subtypes of PCOS are rare in the literature. We aim to contribute to the knowledge in this field with the results we obtained from this study.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Uşak, Turkey, 64100
- Usak Egitim Ve Araştırma Hastanesi
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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 medications that will affect uric acid levels,
- Female patients without active infection will be included. -
Exclusion Criteria:
- Female patients under eighteen years of age and >35 years of age,
- Patients with known cancer, liver and kidney failure,
- Patients taking medications that will affect uric acid levels,
- Patients with active infection will be excluded. -
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Controls
Healthy controls between aged 18 and 35 years
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An amount of 2-3 ml of blood sample will be collected from the patients after 8-12 hours of fasting and will be kept frozen at -70 degrees to calculate the serum UA level.
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PCOS Subtype 1
Hyperandrogenemia+oligoanovulation+PCO appearance on USG
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An amount of 2-3 ml of blood sample will be collected from the patients after 8-12 hours of fasting and will be kept frozen at -70 degrees to calculate the serum UA level.
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PCOS Subtype 2
Hyperandrogenemia+oligoanovulation
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An amount of 2-3 ml of blood sample will be collected from the patients after 8-12 hours of fasting and will be kept frozen at -70 degrees to calculate the serum UA level.
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PCOS Subtype 3
Hyperandrogenemia+ PCO appearance on USG
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An amount of 2-3 ml of blood sample will be collected from the patients after 8-12 hours of fasting and will be kept frozen at -70 degrees to calculate the serum UA level.
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PCOS Subtype 4
Oligoanovulation+ PCO appearance on USG
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An amount of 2-3 ml of blood sample will be collected from the patients after 8-12 hours of fasting and will be kept frozen at -70 degrees to calculate the serum UA level.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Uric acid levels in PCOS subtypes
Time Frame: Eight months
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Since there are different metabolic effects in different subtypes of polycystic ovary syndrome; In this study we aimed to investigate whether there is a difference between serum UA levels in different PCOS subtypes and the difference between these subtypes and the healthy group.
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Eight months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms
- Endocrine System Diseases
- Disease
- Ovarian Cysts
- Cysts
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Polycystic Ovary Syndrome
- Syndrome
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Protective Agents
- Antioxidants
- Uric Acid
Other Study ID Numbers
- Usakupcos1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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