Polycystic Ovary SyndromeNCT06601725
Clusterin Level and Polycystic Ovary Syndrome
An observational study of Polycystic Ovary Syndrome and Ovulation Disorder, run by Sanliurfa Mehmet Akif Inan Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Clusterin, a protein involved in metabolic syndrome, insulin resistance, and metabolic disorders associated with inflammation and oxidative stress such as atherosclerosis, Alzheimer's and some malignancies, has elevated levels in metabolic syndrome, PCOS, and the combination of these two groups. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome, Ovulation Disorder
- What is being tested?
- Clusterin level
- How many people
- 118 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2021to 1 Dec 2021
- How long will I take part?
- 7 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: 118 women who were diagnosed with polycystic ovary syndrome (PCOS) according to the Rotterdam criteria, as well as 62 healthy women of the same age without any cardiovascular risk factors. Patients diagnosed with PCOS were classified into four phenotypes: A, B, C, and D. Phenotype A was characterized by metabolic syndrome, phenotype B was characterized by the absence of metabolic syndrome, phenotype C was characterized by hyperandrogenism, and phenotype D was characterized by the absence of hyperandrogenism.
Who may be able to join
- Women aged between 18 and 45,
- natural bilateral ovaries and no functional cysts on transvaginal ultrasound.
Who cannot join
- who have hyperandrogenism/hyperandrogenemia
- who have non-classical congenital adrenal hyperplasia (17 OHP value >2 nmol/L)
- who have thyroid disease (TSH >5 mlU/L),
- women with hyperprolactinemia (Prolactin>30 mlU/mL)
- patients taking hormonal drugs or ovulation induction agents.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clusterin Level Determination and Its Association With Metabolic Syndrome in Patients With Polycystic Ovary Syndrome
Clusterin, a protein involved in metabolic syndrome, insulin resistance, and metabolic disorders associated with inflammation and oxidative stress such as atherosclerosis, Alzheimer's and some malignancies, has elevated levels in metabolic syndrome, PCOS, and the combination of these two groups. Clusterin could be used as an inflammatory marker to predict PCOS and metabolic syndrome.
Read the detailed description
The study included 118 women diagnosed with PCOS according to the Rotterdam criteria and 62 age-matched healthy women without cardiovascular risk factors. The patients diagnosed with PCOS were also classified into phenotypes. No interventional examination was requested for patients A, B, C, and D, except for hormonal tests and blood collection for Human Clusterin. The demographic and clinical characteristics of all patients were compared, with the primary outcome being blood Clusterin levels. The secondary outcomes are blood Clusterin levels in women with and without metabolic syndrome in addition to PCOS, the relationship between PCOS phenotypes and Clusterin levels, and the relationship between Clusterin levels and clinical and laboratory parameters.
- Conditions
- Polycystic Ovary Syndrome, Ovulation Disorder
- Being tested
- Clusterin level
- Keywords
- clusterin, metabolic syndrome
- Medical subject headings
- Polycystic Ovary Syndrome, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clusterin levelDiagnostic test
Clusterin plays a role in inflammation and oxidative stress processes such as metabolic syndrome, insulin resistance, and atherosclerosis
| Study group | Role | What they receive |
|---|---|---|
| Phenotype A | Phenotype A was characterized by metabolic syndrome Receives: Diagnostic Test: Clusterin level | |
| Phenotype B | phenotype B was characterized by the absence of metabolic syndrome Receives: Diagnostic Test: Clusterin level | |
| Phenotype C | phenotype C was characterized by hyperandrogenism Receives: Diagnostic Test: Clusterin level | |
| Phenotype D | phenotype D was characterized by the absence of hyperandrogenism Receives: Diagnostic Test: Clusterin level |
What is being measured
The primary outcome is the main question the study is designed to answer.
CLusterin level
primary outcome is the measurement of blood Clusterin (Apolipoprotein J) levels in healthy women with and without PCOS
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Apr 2021
- Primary completion1 Nov 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 118 participants (actual)
- Target duration
- 7 Months
Sponsor and investigators
- Lead sponsor
- Sanliurfa Mehmet Akif Inan Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nefise Nazlı YENIGUL, Sanliurfa Mehmet Akif Inan Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06601725
- Sponsor's protocol ID
- 2011-KAEK-25 2021/02-06
- Status last verified
- Sep 2024
- First submitted
- 16 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clusterin Level Determination and Its Association With Metabolic Syndrome in Patients With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT06601725
- Acronym / sponsor ID
- 2011-KAEK-25 2021/02-06
- Conditions
- Polycystic Ovary Syndrome, Ovulation Disorder
- Keywords
- clusterin, metabolic syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Sanliurfa Mehmet Akif Inan Education and Research HospitalUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 19 Sep 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.
Clusterin, a protein involved in metabolic syndrome, insulin resistance, and metabolic disorders associated with inflammation and oxidative stress such as atherosclerosis, Alzheimer's and some malignancies, has elevated levels in metabolic syndrome, PCOS, and the combination of these two groups. Clusterin could be used as an inflammatory marker to predict PCOS and metabolic syndrome.
Detailed description
The study included 118 women diagnosed with PCOS according to the Rotterdam criteria and 62 age-matched healthy women without cardiovascular risk factors. The patients diagnosed with PCOS were also classified into phenotypes. No interventional examination was requested for patients A, B, C, and D, except for hormonal tests and blood collection for Human Clusterin. The demographic and clinical characteristics of all patients were compared, with the primary outcome being blood Clusterin levels. The secondary outcomes are blood Clusterin levels in women with and without metabolic syndrome in addition to PCOS, the relationship between PCOS phenotypes and Clusterin levels, and the relationship between Clusterin levels and clinical and laboratory parameters.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 7 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Phenotype A | – | Diagnostic Test: Clusterin levelPhenotype A was characterized by metabolic syndrome |
| Phenotype B | – | Diagnostic Test: Clusterin levelphenotype B was characterized by the absence of metabolic syndrome |
| Phenotype C | – | Diagnostic Test: Clusterin levelphenotype C was characterized by hyperandrogenism |
| Phenotype D | – | Diagnostic Test: Clusterin levelphenotype D was characterized by the absence of hyperandrogenism |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 118 women who were diagnosed with polycystic ovary syndrome (PCOS) according to the Rotterdam criteria, as well as 62 healthy women of the same age without any cardiovascular risk factors. Patients diagnosed with PCOS were classified into four phenotypes: A, B, C, and D. Phenotype A was characterized by metabolic syndrome, phenotype B was characterized by the absence of metabolic syndrome, phenotype C was characterized by hyperandrogenism, and phenotype D was characterized by the absence of hyperandrogenism.
Key inclusion criteria (2 listed)
- Women aged between 18 and 45,
- natural bilateral ovaries and no functional cysts on transvaginal ultrasound.
Key exclusion criteria (5 listed)
- who have hyperandrogenism/hyperandrogenemia
- who have non-classical congenital adrenal hyperplasia (17 OHP value >2 nmol/L)
- who have thyroid disease (TSH >5 mlU/L),
- women with hyperprolactinemia (Prolactin>30 mlU/mL)
- patients taking hormonal drugs or ovulation induction agents.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clusterin levelClusterin plays a role in inflammation and oxidative stress processes such as metabolic syndrome, insulin resistance, and atherosclerosis | Diagnostic test | Phenotype A, Phenotype B, Phenotype C, Phenotype D |
Primary outcome
CLusterin level
Time frame: 7 months
primary outcome is the measurement of blood Clusterin (Apolipoprotein J) levels in healthy women with and without PCOS
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 19 Sep 2024.
- Individual participant dataSharing planned: No
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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 Polycystic Ovary Syndrome and Ovulation Disorder, run by Sanliurfa Mehmet Akif Inan Education and Research Hospital 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 2 inclusion and 5 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 19 Sep 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?
CLusterin level (time frame: 7 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 19 Sep 2024.