- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06358300
Visceral Adiposity Index Differences Between Subtypes of Polycystic Ovary Syndrome
Visceral Adiposity Index Levels in Polycystic Ovary Syndrome Subtypes
Study Overview
Status
Detailed Description
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 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.
Patients with polycystic ovary syndrome often have abdominal obesity, which leads to hypertension, dyslipidemia, impaired glucose tolerance, Type 2 Diabetes and metabolic syndrome, which predisposes to the development of cardiovascular disease. Visceral adiposity is associated with abnormal lipid levels, proinflammatory activity, insulin resistance, and hyperandrogenism. Increased visceral adiposity increases the risk of metabolic syndrome, Type 2 Diabetes, and cardiovascular events in women with PCOS; It also aggravates ovulation dysfunction and hyperandrogenism.
Visceral adiposity index (VAI) is a simple marker of visceral adipose tissue dysfunction and visceral adiposity and is associated with insulin resistance, hyperinsulinemia, hyperandrogenism and anovulation. Visceral adiposity index (VAI) is one of the new methods used to determine visceral adiposity and predict cardiometabolic risks in patients. Visceral adiposity index is the strongest marker determining metabolic syndrome in both obese and non-obese PCOS patients. Visceral adiposity index is calculated with the formula [Waist circumference / (36.58 + (1.88xBMI)] x (Triglyceride/0.81) x (1.52/HDL-C). Visceral adiposity index is used in the clinical presentations of PCOS and treatment success. It is reported to be a useful marker that enables early detection and intervention of the risk of metabolic syndrome in women. Since there are different metabolic effects in different subtypes of PCOS, we aimed to investigate whether there is a difference between visceral adiposity indexes in different PCOS subtypes.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Usak, Turkey, 64100
- Uşak Training and Research Hospital
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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 HDL, TG levels and insulin resistance,
- 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 HDL, TG levels and insulin resistance,
- Patients with active infection will not be included in the study. -
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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PCOS Subtype 1
Hyperandrogenemia+oligoanovulation+PCO appearance on USG
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PCOS Subtype 2
Hyperandrogenemia+oligoanovulation
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Controls
Healthy controls between aged 18-35 years
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PCOS Subtype 3
Hyperandrogenemia+PCO appearance on USG
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PCOS Subtype 4
Oligoanovulation+PCO appearance on USG
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Visceral Adiposity Index Differences Between Subtypes of Polycystic Ovary Syndrome
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 VAI 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
- Overnutrition
- Nutrition Disorders
- Overweight
- Body Weight
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Polycystic Ovary Syndrome
- Syndrome
- Obesity
Other Study ID Numbers
- Usakpcos2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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