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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06358300
Other study ID # Usakpcos2
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2022
Est. completion date July 20, 2023

Study information

Verified date April 2024
Source Usak University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

We aimed to investigate visceral adiposity index (VAI) in patients with different phenotype of policystic ovary syndrome (PCOS) and to compare healthy controls.


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.


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date July 20, 2023
Est. primary completion date September 1, 2022
Accepts healthy volunteers
Gender Female
Age group 18 Years to 35 Years
Eligibility 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 medications that will affect HDL, TG levels and insulin resistance, 5. Female patients without active infection will be included. - Exclusion Criteria: 1. Female patients under eighteen years of age and >35 years of age, 2. Patients with known cancer, liver and kidney failure, 3. Patients taking medications that will affect HDL, TG levels and insulin resistance, 4. Patients with active infection will not be included in the study. -

Study Design


Locations

Country Name City State
Turkey Usak Training and Research Hospital Usak

Sponsors (1)

Lead Sponsor Collaborator
Usak University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Visceral Adiposity Index Differences Between Subtypes of Polycystic Ovary Syndrome 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. Eight months
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