[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657803":3},{"organization":4,"outcomesModule":7,"designInfo":56,"detailedDescription":59,"studyPopulation":60,"armGroups":61,"interventions":71,"overallOfficials":55,"centralContacts":77,"locations":55,"responsibleParty":83,"collaborators":55,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":93,"sex":94,"minAge":95,"maxAge":96,"enrollmentInfo":97,"targetDuration":55,"studyType":100,"phases":55,"briefSummary":101,"conditions":102,"keywords":55,"overallStatus":108,"whyStopped":55,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":55},{"fullName":5,"class":6},"Istinye University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":55},[9],{"measure":10,"description":11,"timeFrame":12},"Correlation Between Serum and Salivary Fetuin-A and Resistin Levels","To determine the correlation between serum and salivary Fetuin-A and resistin concentrations in women with Polyendocrine Metabolic Ovarian Syndrome (PMOS) and healthy controls.","At baseline (Day 1)",[14,18,21,24,27,30,33,36,39,42,44,46,48,51,53],{"measure":15,"description":16,"timeFrame":17},"Serum Fetuin-A Levels","Comparison of serum Fetuin-A concentrations between women with PMOS and healthy controls.","Baseline",{"measure":19,"description":20,"timeFrame":17},"Salivary Fetuin-A Levels","Comparison of salivary Fetuin-A concentrations between women with PMOS and healthy controls",{"measure":22,"description":23,"timeFrame":17},"Serum Resistin Levels","Comparison of serum resistin concentrations between women with PMOS and healthy controls.",{"measure":25,"description":26,"timeFrame":17},"Salivary Resistin Levels","Comparison of salivary resistin concentrations between women with PMOS and healthy controls.",{"measure":28,"description":29,"timeFrame":17},"Correlation Between Fetuin-A and Resistin Concentrations and HOMA-IR","Serum and salivary Fetuin-A and resistin concentrations measured by ELISA will be correlated with HOMA-IR. HOMA-IR will be calculated from fasting glucose and fasting insulin concentrations. Correlations will be assessed using Pearson or Spearman correlation coefficients, as appropriate.",{"measure":31,"description":32,"timeFrame":17},"Correlation Between Fetuin-A and Resistin Concentrations and SHBG Concentration","Serum and salivary Fetuin-A and resistin concentrations measured by ELISA will be correlated with serum sex hormone-binding globulin (SHBG) concentration. Correlations will be assessed using Pearson or Spearman correlation coefficients, as appropriate.",{"measure":34,"description":35,"timeFrame":17},"Correlation of Fetuin-A and Resistin Concentrations With DHEAS Concentration","Serum and salivary Fetuin-A and resistin concentrations measured by ELISA will be correlated with serum dehydroepiandrosterone sulfate (DHEAS) concentration. Correlations will be assessed using Pearson or Spearman correlation coefficients, as appropriate.",{"measure":37,"description":38,"timeFrame":17},"Correlation of Fetuin-A and Resistin Concentrations With Free Androgen Index","Serum and salivary Fetuin-A and resistin concentrations measured by ELISA will be correlated with the Free Androgen Index (FAI), calculated as (total testosterone \u002F SHBG) × 100. Correlations will be assessed using Pearson or Spearman correlation coefficients, as appropriate.",{"measure":40,"description":41,"timeFrame":17},"Correlation of Fetuin-A and Resistin Concentrations With Total Cholesterol Concentration","Serum and salivary Fetuin-A and resistin concentrations measured by ELISA will be correlated with serum \\[total cholesterol \u002F LDL cholesterol \u002F HDL cholesterol \u002F triglyceride\\] concentration. Correlations will be assessed using Pearson or Spearman correlation coefficients, as appropriate.",{"measure":43,"description":41,"timeFrame":17},"Correlation of Fetuin-A and Resistin Concentrations With LDL Cholesterol Concentration",{"measure":45,"description":41,"timeFrame":17},"Correlation of Fetuin-A and Resistin Concentrations With HDL Cholesterol Concentration",{"measure":47,"description":41,"timeFrame":17},"Correlation of Fetuin-A and Resistin Concentrations With Triglyceride Concentration",{"measure":49,"description":50,"timeFrame":17},"Correlation Between Fetuin-A and Resistin Concentrations and Total Testosterone Concentration","Serum and salivary Fetuin-A and resistin concentrations measured by ELISA will be correlated with serum total testosterone concentration. Correlations will be assessed using Pearson or Spearman correlation coefficients, as appropriate.",{"measure":52,"description":35,"timeFrame":17},"Correlation Between Fetuin-A and Resistin Concentrations and DHEAS Concentration",{"measure":54,"description":38,"timeFrame":17},"Correlation Between Fetuin-A and Resistin Concentrations and Free Androgen Index",null,{"allocation":55,"interventionModel":55,"interventionModelDescription":55,"primaryPurpose":55,"observationalModel":57,"timePerspective":58,"maskingInfo":55},"CASE_CONTROL","PROSPECTIVE","Polyendocrine Metabolic Ovarian Syndrome (PMOS) is a complex endocrine disorder characterized by reproductive, metabolic, and hormonal abnormalities. Insulin resistance, chronic low-grade inflammation, and hyperandrogenism play central roles in its pathophysiology. Identifying reliable and non-invasive biomarkers may improve early diagnosis, metabolic risk assessment, and long-term clinical follow-up.\n\nFetuin-A is a glycoprotein involved in insulin signaling and glucose metabolism, whereas resistin is a pro-inflammatory adipokine associated with insulin resistance and metabolic dysfunction. Previous studies evaluating serum concentrations of these biomarkers in women with PMOS have reported inconsistent findings, and little is known about whether salivary concentrations accurately reflect serum levels.\n\nThis prospective observational case-control study will enroll 80 women aged 18-35 years, including 40 women diagnosed with PMOS according to the Rotterdam criteria and 40 age-matched healthy controls. Fasting blood and unstimulated saliva samples will be collected simultaneously. Serum and salivary Fetuin-A and resistin concentrations will be measured using enzyme-linked immunosorbent assay (ELISA). Metabolic and hormonal parameters, including fasting glucose, fasting insulin, HbA1c, lipid profile, total testosterone, sex hormone-binding globulin (SHBG), dehydroepiandrosterone sulfate (DHEAS), and the free androgen index (FAI), will also be evaluated.\n\nThe primary objective is to determine the correlation between serum and salivary Fetuin-A and resistin levels. Secondary objectives include evaluating associations between these biomarkers and insulin resistance, lipid profile, anthropometric measurements, and hormonal parameters, as well as assessing the potential utility of salivary biomarkers as non-invasive tools for the metabolic evaluation of women with PMOS.","Women aged 18-35 years with Polyendocrine Metabolic Ovarian Syndrome (PMOS) and age-matched healthy women recruited from the outpatient gynecology and endocrinology clinics of Istinye University. Participants will undergo clinical evaluation and fasting blood and unstimulated saliva collection for biochemical analyses.",[62,67],{"label":63,"type":55,"description":64,"interventionNames":65},"PMOS Group","Women aged 18 to 35 years diagnosed with Polyendocrine Metabolic Ovarian Syndrome according to the Rotterdam criteria. Participants will undergo clinical and anthropometric evaluation, and fasting serum and unstimulated saliva samples will be collected for Fetuin-A, resistin, metabolic, and hormonal measurements.",[66],"Diagnostic Test: Blood and Saliva Biomarker Assessment",{"label":68,"type":55,"description":69,"interventionNames":70},"Healthy Control Group","Women aged 18 to 35 years with regular menstrual cycles and without Polyendocrine Metabolic Ovarian Syndrome. Participants will undergo the same clinical, anthropometric, serum, and saliva assessments as the PMOS group.",[66],[72],{"type":73,"name":74,"description":75,"armGroupLabels":76,"otherNames":55},"DIAGNOSTIC_TEST","Blood and Saliva Biomarker Assessment","Participants will provide fasting venous blood and unstimulated saliva samples for measurement of Fetuin-A and resistin concentrations using enzyme-linked immunosorbent assay (ELISA). Metabolic and hormonal parameters, including fasting glucose, fasting insulin, HbA1c, lipid profile, total testosterone, sex hormone-binding globulin (SHBG), and dehydroepiandrosterone sulfate (DHEAS), will also be assessed. No therapeutic intervention will be administered.",[68,63],[78],{"name":79,"role":80,"phone":81,"phoneExt":55,"email":82},"Ayşe İrem GÖKÇEK Dr, Dr","CONTACT","5356476880","ayse.gokcek@istinye.edu.tr",{"type":84,"investigatorFullName":55,"investigatorTitle":55,"investigatorAffiliation":55,"oldNameTitle":55,"oldOrganization":55},"SPONSOR","100657803","metabolic-and-hormonal-parameters-in-women-with-polyendocrine-metabolic-ovarian-syndrome-100657803",false,"NCT07844785","Metabolic and Hormonal Parameters in Women With Polyendocrine Metabolic Ovarian Syndrome","Correlation of Serum and Salivary Fetuin-A and Resistin Levels With Metabolic and Hormonal Parameters in Women With Polyendocrine Metabolic Ovarian Syndrome","PMOS-FR","Inclusion Criteria:\n\nPMOS Group:\n\n* Female, aged 18-35 years\n* Diagnosis of Polyendocrine Metabolic Ovarian Syndrome (PMOS) according to the Rotterdam criteria\n* BMI \\\u003C30 kg\u002Fm²\n* Written informed consent\n\nHealthy Control Group:\n\n* Female, aged 18-35 years\n* Regular menstrual cycles\n* No diagnosis of PMOS\n* BMI \\\u003C30 kg\u002Fm²\n* Written informed consent\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding\n* Diabetes mellitus\n* Chronic kidney or liver disease\n* Thyroid dysfunction\n* Hyperprolactinemia\n* Cushing syndrome\n* Non-classic congenital adrenal hyperplasia\n* Use of hormonal contraceptives, anti-androgens, glucocorticoids, metformin, or insulin-sensitizing medications within the previous 3 months\n* Severe periodontal disease or active oral infection",true,"FEMALE","18 Years","35 Years",{"count":98,"type":99},80,"ESTIMATED","OBSERVATIONAL","Polyendocrine Metabolic Ovarian Syndrome (PMOS) is a common endocrine and metabolic disorder associated with insulin resistance, hyperandrogenism, and an increased risk of long-term metabolic complications. Fetuin-A and resistin are adipokines implicated in insulin resistance and chronic inflammation and may serve as potential biomarkers for metabolic dysfunction in women with PMOS.\n\nThis prospective observational case-control study aims to compare serum and salivary Fetuin-A and resistin levels between women with PMOS and healthy controls. The study will evaluate the correlation between serum and salivary biomarker concentrations and investigate their associations with insulin resistance, lipid profile, and hormonal parameters. The findings may help determine whether salivary measurements can serve as reliable non-invasive biomarkers for the diagnosis and metabolic assessment of PMOS.",[103,104,105,106,107],"Polycystic Ovary Syndrome","Polycystic Ovary Syndrome (PCOS) Women","Fetuin-A","Serum Biomarkers","Insulin Resistance","NOT_YET_RECRUITING","2026-09-22",{"date":111,"type":112},"2026-09-28","ACTUAL",{"date":114,"type":99},"2026-09-01",{"date":116,"type":99},"2027-08-30",{"name":5,"class":6}]