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Breath Mass Spectrometry in Metabolic Syndrome and Metabolically Healthy Obesity

Recruitingn/aAges 18 Years - anyAllI.M. Sechenov First Moscow State Medical Universi…
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * For Group 1 (Metabolic syndrome): Age \>18 years, signed informed consent, diagnosis of Metabolic Syndrome (IDF 2006 criteria: waist circumference \>94 cm (men)/ \>80 cm (women) + ≥2 of: BP ≥130/85 mmHg or antihypertensive therapy; TG ≥1.7 mmol/L; HDL-C \<1.03 mmol/L (men) / \<1.29 mmol/L (women); Fasting glucose ≥5.6 mmol/L). * For Group 2 (Metabolically healthy obesity): Age \>18 years, signed informed consent, waist circumference ≥94 cm (men) / ≥80 cm (women), absence of other Metabolic Syndrome criteria (hypertension, dyslipidemia, impaired fasting glucose). * For Group 3 (Control): Age \>18 years, signed informed consent, normal BMI, absence of signs of Metabolic Syndrome. Non-inclusion criteria for all groups: * Inability to provide informed consent; * History of myocardial infarction or stroke; * Chronic kidney disease stage 3B, 4, 5 (eGFR \<30 ml/min/1.73m2); * Acute or subacute cardiovascular disease; * Familial hypercholesterolemia; * Bronchopulmonary diseases; * Acute or chronic infectious diseases; * Type 1 or Type 2 diabetes mellitus; * Systemic connective tissue diseases; * Current or past history of oncological diseases; * Severe liver dysfunction, decompensated liver cirrhosis (Child-Pugh class C); * Pregnancy or lactation; * Severe mental illness (severe dementia, schizophrenia); * Comorbid conditions with life expectancy less than 1 year. Exclusion Criteria: * Patient refusal to continue participation in the study; * Identification of any non-inclusion criteria after enrollment.
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What it tests

  • Breath Sampling and Analysis by PTR-MS
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Where

1 site
University Clinical Hospital №1, Sechenov University
Moscow, Russia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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