Endocan Levels at Polycystic Ovary Syndrome and Periodontal Inflammation

Polycystic Ovary Syndrome Clinical Trial

Official title:

The Levels of Interleukin-6 and Endocan at Individuals With Polycystic Ovary Syndrome and Periodontal Inflammation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03264846
• Other study ID #: EbSAGLAM1
• Status: Completed
• Start date: April 3, 2017
• Est. completion date: November 29, 2017

Study information

• Verified date: February 2020
• Source: Bezmialem Vakif University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: November 29, 2017
• Est. primary completion date: November 29, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Newly diagnosed PCOS patients

• Never smokers

• Had no history of systemic disease

• BMI<25 kg/m2

• Participants had =20 teeth present.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Cytokines
• Gingivitis
• Inflammation
• Inflammation Gum
• Polycystic Ovary Syndrome
• Syndrome

Intervention

Diagnostic Test:
• Collection of Serum and Saliva Samples
Whole saliva samples were obtained via expectorating into polypropylene tubes venous blood were obtained from the antecubital vein via the standard venipuncture method.

Locations

Country	Name	City	State
Turkey	Ebru Saglam	Istanbul	Eyalet/Yerleske

Sponsors (2)

Lead Sponsor	Collaborator
Ebru Saglam	Ataturk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum and salivary Endocan levels	Enzyme-Linked Immunosorbent Assay (ELISA)	one year
Primary	Serum and salivary interleukin-6 levels	Enzyme-Linked Immunosorbent Assay (ELISA)	one year
Secondary	Clinical attachment level (CAL)	Periodontal measurement	one year
Secondary	Probing pocket depth (PD)	Periodontal measurement	one year
Secondary	Gingival Index	Periodontal measurement	One year