Visceral Adiposity IndexNCT06358300
Visceral Adiposity Index Differences Between Subtypes of Polycystic Ovary Syndrome
An observational study of Visceral Adiposity Index and Polycystic Ovary Syndrome, run by Uşak University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Visceral Adiposity Index, Polycystic Ovary Syndrome
- How many people
- 300 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 20 Jul 2023
- How long will I take part?
- 16 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Adult
Study population: Woman aged between 18 and 35, age-matched between groups, diagnosed with PCOS and without a known cancer diagnosis, liver and kidney failure, not taking medications that would affect HDL, TG levels and insulin resistance and without active infection.
Who may be able to join
- 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. -
Who cannot join
- 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. -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Usak Training and Research Hospital
Uşak, 64100
About this study
Official title: Visceral Adiposity Index Levels in Polycystic Ovary Syndrome Subtypes
We aimed to investigate visceral adiposity index (VAI) in patients with different phenotype of policystic ovary syndrome (PCOS) and to compare healthy controls.
Read the 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.
- Keywords
- Polycystic ovary syndrome, Visceral Adiposity Index, PCOS Subtypes
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Controls | Healthy controls between aged 18-35 years | |
| PCOS Subtype 1 | Hyperandrogenemia+oligoanovulation+PCO appearance on USG | |
| PCOS Subtype 2 | Hyperandrogenemia+oligoanovulation | |
| PCOS Subtype 3 | Hyperandrogenemia+PCO appearance on USG | |
| PCOS Subtype 4 | Oligoanovulation+PCO appearance on USG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Eight months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start1 Jan 2022
- Primary completion1 Sep 2022
- Study completion20 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visceral Adiposity IndexStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
- Target duration
- 16 Months
Sponsor and investigators
- Lead sponsor
- Uşak University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06358300
- Sponsor's protocol ID
- Usakpcos2
- Status last verified
- Apr 2024
- First submitted
- 4 Apr 2024
- Last updated
- 10 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visceral Adiposity Index Levels in Polycystic Ovary Syndrome Subtypes
- ClinicalTrials.gov ID
- NCT06358300
- Acronym / sponsor ID
- Usakpcos2
- Keywords
- Polycystic ovary syndrome, Visceral Adiposity Index, PCOS Subtypes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Uşak UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 20 Jul 2023 (actual)
- First posted
- 10 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We aimed to investigate visceral adiposity index (VAI) in patients with different phenotype of policystic ovary syndrome (PCOS) and to compare healthy controls.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 16 Months
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Controls | – | –Healthy controls between aged 18-35 years |
| PCOS Subtype 1 | – | –Hyperandrogenemia+oligoanovulation+PCO appearance on USG |
| PCOS Subtype 2 | – | –Hyperandrogenemia+oligoanovulation |
| PCOS Subtype 3 | – | –Hyperandrogenemia+PCO appearance on USG |
| PCOS Subtype 4 | – | –Oligoanovulation+PCO appearance on USG |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Woman aged between 18 and 35, age-matched between groups, diagnosed with PCOS and without a known cancer diagnosis, liver and kidney failure, not taking medications that would affect HDL, TG levels and insulin resistance and without active infection.
Key inclusion criteria (5 listed)
- 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. -
Key exclusion criteria (4 listed)
- 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. -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Visceral Adiposity Index Differences Between Subtypes of Polycystic Ovary Syndrome
Time frame: Eight months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Visceral Adiposity Index and Polycystic Ovary Syndrome, run by Uşak University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visceral Adiposity Index Differences Between Subtypes of Polycystic Ovary Syndrome (time frame: Eight months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2024.