Polycystic Ovary SyndromeNCT03264846
Endocan Levels at Polycystic Ovary Syndrome and Periodontal Inflammation
An observational study of Polycystic Ovary Syndrome and Inflammation Gum, run by Ebru Saglam at 1 site in Turkey (Türkiye).
Trial summary
Periodontal diseases are chronic inflammatory disease occurred by the interaction between pathogenic microorganism and the host defense. Polycystic ovary syndrome (PCOS) is a reproductive and metabolic disease associated with increased risk of cardiovascular events. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome, Inflammation Gum, Cytokines
- What is being tested?
- Collection of Serum and Saliva Samples
- How many people
- 87 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Apr 2017to 29 Nov 2017
- How long will I take part?
- 1 Day
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: All participants were included among women at the Department of Obstetrics and Gynecology, School of Medicine and Department of Periodontology, Faculty of Dentistry , Ataturk University
Who may be able to join
- Newly diagnosed PCOS patients
- Never smokers
- Had no history of systemic disease
- BMI<25 kg/m2
- Participants had ≥20 teeth present.
Who cannot join
- Pregnancy
- Lactation
- Hemoglobin A1c (HbA1c) ≥ 6.5%
- 2-h oral glucose tolerance test (OGTT-2h) ≥200
- Cushing syndrome, non-classic congenital adrenal hyperplasia, hyperprolactinemia, thyroid dysfunction, and androgen-secreting tumors
- Using antibiotics and antiinflammatory within the past 6 months
- Periodontal treatment within the past 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Levels of Interleukin-6 and Endocan at Individuals With Polycystic Ovary Syndrome and Periodontal Inflammation
Periodontal diseases are chronic inflammatory disease occurred by the interaction between pathogenic microorganism and the host defense. Polycystic ovary syndrome (PCOS) is a reproductive and metabolic disease associated with increased risk of cardiovascular events. Endocan is a proteoglycan secreted mainly by endothelial cells under the control of inflammatory cytokines.
Periodontal diseases, including gingivitis, are common chronic infectious diseases caused by predominantly pathogenic microorganisms that colonize the subgingival area and cause local and systemic elevations of proinflammatory cytokines such as Interleukin-6 (IL-6).
Read more
Several lines of evidence established the association between periodontal and systemic diseases, including metabolic syndrome, diabetes, and cardiovascular disease.
Because of the fact that both periodontal disease and PCOS are associated with systemic inflammation and insulin resistance, these two disorders may be linked through a common pathophysiologic pathway.
A number of studies have indicated a possible relationship between PCOS and periodontal inflammation. Despite common risk factors, including oxidative stress, the relationship between chronic periodontitis (CP) and PCOS remains unclear.
The aims of the study were to determine serum and saliva Endocan and IL-6 levels and to evaluate the correlation between these two biomarker in women with periodontal disease and PCOS.
- Conditions
- Polycystic Ovary Syndrome, Inflammation Gum, Cytokines
- Being tested
- Collection of Serum and Saliva Samples
- Medical subject headings
- Polycystic Ovary Syndrome, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of Serum and Saliva SamplesDiagnostic test
Whole saliva samples were obtained via expectorating into polypropylene tubes venous blood were obtained from the antecubital vein via the standard venipuncture method.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | PCOS participants with periodontitis Receives: Diagnostic Test: Collection of Serum and Saliva Samples | |
| Group 2 | PCOS participants with periodontally healthy Receives: Diagnostic Test: Collection of Serum and Saliva Samples | |
| Group 3 | systemically healthy participants with periodontitis Receives: Diagnostic Test: Collection of Serum and Saliva Samples | |
| Group 4 | systemically and periodontally healthy participants Receives: Diagnostic Test: Collection of Serum and Saliva Samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum and salivary Endocan levels
Enzyme-Linked Immunosorbent Assay (ELISA)
Measured: one year
Serum and salivary interleukin-6 levels
Enzyme-Linked Immunosorbent Assay (ELISA)
Measured: one year
Secondary outcomes (3)
Clinical attachment level (CAL)
Periodontal measurement
Measured: one year
Probing pocket depth (PD)
Periodontal measurement
Measured: one year
Gingival Index
Periodontal measurement
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study start3 Apr 2017
- Primary completion29 Nov 2017
- Study completion29 Nov 2017
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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 87 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Ebru Saglam
- Sponsor type
- University, hospital or other
- Collaborators
- Ataturk University
- Responsible party
- Sponsor-investigator, Ebru Saglam, Bezmialem Vakif University
- Investigators
- Ebru Sağlam, PhD, Study director, Bezmialem Vakif UniversityAyşe Toraman, Principal investigator, Ataturk UniversityEngin Şebin, Principal investigator, Erzurum Regional Training and Research HospitalCenk Fatih Çanakçı, Professor, Study chair, Ataturk UniversityHümeyra Çanakçı, Dr, Principal investigator, Private PracticeMetin İngeç, Professor, Study director, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03264846
- Sponsor's protocol ID
- EbSAGLAM1
- Status last verified
- Feb 2020
- First submitted
- 23 Aug 2017
- Last updated
- 10 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Levels of Interleukin-6 and Endocan at Individuals With Polycystic Ovary Syndrome and Periodontal Inflammation
- ClinicalTrials.gov ID
- NCT03264846
- Acronym / sponsor ID
- EbSAGLAM1
- Conditions
- Polycystic Ovary Syndrome, Inflammation Gum, Cytokines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Ebru SaglamUniversity, hospital or other
- Collaborators
- Ataturk University
- Study start
- 3 Apr 2017 (actual)
- Primary completion
- 29 Nov 2017 (actual)
- Study completion
- 29 Nov 2017 (actual)
- First posted
- 29 Aug 2017 (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.
Periodontal diseases are chronic inflammatory disease occurred by the interaction between pathogenic microorganism and the host defense. Polycystic ovary syndrome (PCOS) is a reproductive and metabolic disease associated with increased risk of cardiovascular events. Endocan is a proteoglycan secreted mainly by endothelial cells under the control of inflammatory cytokines.
Periodontal diseases, including gingivitis, are common chronic infectious diseases caused by predominantly pathogenic microorganisms that colonize the subgingival area and cause local and systemic elevations of proinflammatory cytokines such as Interleukin-6 (IL-6).
Several lines of evidence established the association between periodontal and systemic diseases, including metabolic syndrome, diabetes, and cardiovascular disease.
Because of the fact that both periodontal disease and PCOS are associated with systemic inflammation and insulin resistance, these two disorders may be linked through a common pathophysiologic pathway.
A number of studies have indicated a possible relationship between PCOS and periodontal inflammation. Despite common risk factors, including oxidative stress, the relationship between chronic periodontitis (CP) and PCOS remains unclear.
The aims of the study were to determine serum and saliva Endocan and IL-6 levels and to evaluate the correlation between these two biomarker in women with periodontal disease and PCOS.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Diagnostic Test: Collection of Serum and Saliva SamplesPCOS participants with periodontitis |
| Group 2 | – | Diagnostic Test: Collection of Serum and Saliva SamplesPCOS participants with periodontally healthy |
| Group 3 | – | Diagnostic Test: Collection of Serum and Saliva Samplessystemically healthy participants with periodontitis |
| Group 4 | – | Diagnostic Test: Collection of Serum and Saliva Samplessystemically and periodontally healthy participants |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- All participants were included among women at the Department of Obstetrics and Gynecology, School of Medicine and Department of Periodontology, Faculty of Dentistry , Ataturk University
Key inclusion criteria (5 listed)
- Newly diagnosed PCOS patients
- Never smokers
- Had no history of systemic disease
- BMI<25 kg/m2
- Participants had ≥20 teeth present.
Key exclusion criteria (7 listed)
- Pregnancy
- Lactation
- Hemoglobin A1c (HbA1c) ≥ 6.5%
- 2-h oral glucose tolerance test (OGTT-2h) ≥200
- Cushing syndrome, non-classic congenital adrenal hyperplasia, hyperprolactinemia, thyroid dysfunction, and androgen-secreting tumors
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 |
|---|---|---|
| Collection of Serum and Saliva SamplesWhole saliva samples were obtained via expectorating into polypropylene tubes venous blood were obtained from the antecubital vein via the standard venipuncture method. | Diagnostic test | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
Serum and salivary Endocan levels
Time frame: one year
Enzyme-Linked Immunosorbent Assay (ELISA)
Serum and salivary interleukin-6 levels
Time frame: one year
Enzyme-Linked Immunosorbent Assay (ELISA)
3 secondary outcomes
Clinical attachment level (CAL)
Time frame: one year
Probing pocket depth (PD)
Time frame: one year
Gingival Index
Time frame: One year
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 Feb 2020.
- Individual participant dataSharing planned: Undecided
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The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
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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.
Ebru Sağlam, PhD study director
Bezmialem Vakif University
Ayşe Toraman principal investigator
Ataturk University
Engin Şebin principal investigator
Erzurum Regional Training and Research Hospital
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 Inflammation Gum, run by Ebru Saglam 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 7 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 Feb 2020. 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?
Serum and salivary Endocan levels (time frame: one year). The study lists 2 primary outcomes in all. 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 Feb 2020.