[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100618336":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":10,"centralContacts":28,"locations":38,"responsibleParty":53,"collaborators":10,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":10,"eligibilityCriteria":61,"healthyVolunteers":62,"sex":63,"minAge":64,"maxAge":10,"enrollmentInfo":65,"targetDuration":10,"studyType":68,"phases":10,"briefSummary":69,"conditions":70,"keywords":74,"overallStatus":41,"whyStopped":10,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"I.M. Sechenov First Moscow State Medical University","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Metabolic Syndrome Group",null,"100 patients diagnosed with Metabolic Syndrome according to International Diabetes Federation (IDF) 2006 criteria.",[13],"Diagnostic Test: Breath Sampling and Analysis by PTR-MS",{"label":15,"type":10,"description":16,"interventionNames":17},"Metabolically Healthy Obesity Group","100 patients with waist circumference ≥94 cm (men)\u002F≥80 cm (women), but without other components of Metabolic Syndrome (hypertension, dyslipidemia, impaired fasting glucose).",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Control Group","100 individuals with normal BMI and no signs of Metabolic Syndrome.",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":10},"DIAGNOSTIC_TEST","Breath Sampling and Analysis by PTR-MS","A single sample of exhaled breath will be collected from each participant during quiet breathing. The sample will be analyzed in real-time using Proton-Transfer-Reaction Time-of-Flight Mass Spectrometry (Compact PTR-TOF-MS 1000, Ionicon, Austria) to identify and quantify the spectrum of volatile organic compounds (VOCs).",[19,9,15],[29,34],{"name":30,"role":31,"phone":32,"phoneExt":10,"email":33},"Philipp Kopylov","CONTACT","+7 (903) 687-72-64","kopylov_f_yu@staff.sechenov.ru",{"name":35,"role":31,"phone":36,"phoneExt":10,"email":37},"Aida Gadzhiakhmedova","+7 (989) 899-53-01","ai.kidman@mail.ru",[39],{"facility":40,"status":41,"city":42,"state":10,"zip":10,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"University Clinical Hospital №1, Sechenov University","RECRUITING","Moscow","Russia","RU",{"type":46,"coordinates":47},"Point",[48,49],37.61781,55.75204,{"lat":49,"lon":48},[52],{"name":30,"role":31,"phone":32,"phoneExt":10,"email":33},{"type":54,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100618336","breath-mass-spectrometry-in-metabolic-syndrome-and-metabolically-healthy-obesity-100618336",false,"NCT07330297","Breath Mass Spectrometry in Metabolic Syndrome and Metabolically Healthy Obesity","The Capabilities of Exhaled Breath Mass Spectrometry in Identifying Metabolic Syndrome and Metabolically Healthy Obesity","Inclusion Criteria:\n\n* For Group 1 (Metabolic syndrome): Age \\>18 years, signed informed consent, diagnosis of Metabolic Syndrome (IDF 2006 criteria: waist circumference \\>94 cm (men)\u002F \\>80 cm (women) + ≥2 of: BP ≥130\u002F85 mmHg or antihypertensive therapy; TG ≥1.7 mmol\u002FL; HDL-C \\\u003C1.03 mmol\u002FL (men) \u002F \\\u003C1.29 mmol\u002FL (women); Fasting glucose ≥5.6 mmol\u002FL).\n* For Group 2 (Metabolically healthy obesity): Age \\>18 years, signed informed consent, waist circumference ≥94 cm (men) \u002F ≥80 cm (women), absence of other Metabolic Syndrome criteria (hypertension, dyslipidemia, impaired fasting glucose).\n* For Group 3 (Control): Age \\>18 years, signed informed consent, normal BMI, absence of signs of Metabolic Syndrome.\n\nNon-inclusion criteria for all groups:\n\n* Inability to provide informed consent;\n* History of myocardial infarction or stroke;\n* Chronic kidney disease stage 3B, 4, 5 (eGFR \\\u003C30 ml\u002Fmin\u002F1.73m2);\n* Acute or subacute cardiovascular disease;\n* Familial hypercholesterolemia;\n* Bronchopulmonary diseases;\n* Acute or chronic infectious diseases;\n* Type 1 or Type 2 diabetes mellitus;\n* Systemic connective tissue diseases;\n* Current or past history of oncological diseases;\n* Severe liver dysfunction, decompensated liver cirrhosis (Child-Pugh class C);\n* Pregnancy or lactation;\n* Severe mental illness (severe dementia, schizophrenia);\n* Comorbid conditions with life expectancy less than 1 year.\n\nExclusion Criteria:\n\n* Patient refusal to continue participation in the study;\n* Identification of any non-inclusion criteria after enrollment.",true,"ALL","18 Years",{"count":66,"type":67},300,"ESTIMATED","OBSERVATIONAL","This study aims to develop a non-invasive diagnostic method for metabolic syndrome (MetS) and metabolically healthy obesity (MHO) through analysis of exhaled air. Using proton-transfer-reaction mass spectrometry combined with machine learning algorithms, we will characterize volatile organic compound profiles in 300 participants across three groups: MetS patients, MHO patients, and healthy controls. The primary goal is to create and validate a classification model capable of accurately differentiating these metabolic states based on breath analysis.",[71,72,73],"Metabolic Syndrome","Obesity & Overweight","Metabolically Healthy Obesity",[75,76,77,78,79,80,81,82],"Breath Analysis","Volatile Organic Compounds","Proton-Transfer-Reaction Mass Spectrometry","Artificial Intelligence","Machine Learning","Metabolic syndrome","Obesity","Metabolically healthy obesity","2025-12-29",{"date":85,"type":86},"2026-01-09","ACTUAL",{"date":88,"type":86},"2024-09-19",{"date":90,"type":67},"2026-12-30",{"name":5,"class":6},1]