Breath mass spectrometry test to distinguish metabolic syndrome and metabolically healthy obesity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The study will collect exhaled breath from 300 adults divided into three groups (metabolic syndrome, metabolically healthy obesity, and healthy controls) and analyze volatile organic compound profiles using proton-transfer-reaction mass spectrometry (PTR-MS). Machine learning algorithms will be trained on the mass spectrometry data to build and validate a classification model that discriminates the three metabolic states. The approach emphasizes real-time breath analysis and specialized pattern-recognition methods to handle complex volatilome signatures. Results aim to clarify metabolic pathway differences between obesity phenotypes and to validate breathomics as a diagnostic tool.

Why it matters

Who can join: the full rules

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.

Where it's running

• University Clinical Hospital №1, Sechenov University
  Moscow, Russia Recruiting

Study contacts

• Study coordinator: Philipp Kopylov
• Email: kopylov_f_yu@staff.sechenov.ru
• Phone: +7 (903) 687-72-64

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.