Breath Mass Spectrometry in Metabolic Syndrome and Metabolically Healthy Obesity

I.M. Sechenov First Moscow State Medical University

Status: Enrolling

Conditions: Metabolically Healthy Obesity; Obesity & Overweight; Metabolic Syndrome

Treatments: Diagnostic Test: Breath Sampling and Analysis by PTR-MS

Study type: Observational

Funder types: Other

Identifiers

NCT07330297

MHO-MetS-Breath-001

Details and patient eligibility

About

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.

Full description

This study focuses on characterizing the volatilome - the complete set of volatile organic compounds in exhaled air - as a novel biomarker source for metabolic health assessment.

The study represents the first comprehensive attempt to compare volatilome signatures between metabolically healthy and unhealthy obesity phenotypes. Successful validation of this approach could establish breath analysis as a new diagnostic paradigm in metabolic medicine, enabling rapid, non-invasive screening and personalized treatment strategies for patients with obesity-related conditions.

Methodological innovations include real-time breath analysis capabilities and development of specialized machine learning algorithms for pattern recognition in complex mass spectrometry data. The findings are expected to contribute significantly to understanding metabolic pathway alterations in different obesity phenotypes.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

300 participants in 3 patient groups

Metabolic Syndrome Group

Description:

100 patients diagnosed with Metabolic Syndrome according to International Diabetes Federation (IDF) 2006 criteria.

Treatment:

Diagnostic Test: Breath Sampling and Analysis by PTR-MS

Metabolically Healthy Obesity Group

Description:

100 patients with waist circumference ≥94 cm (men)/≥80 cm (women), but without other components of Metabolic Syndrome (hypertension, dyslipidemia, impaired fasting glucose).

Treatment:

Diagnostic Test: Breath Sampling and Analysis by PTR-MS

Control Group

Description:

100 individuals with normal BMI and no signs of Metabolic Syndrome.

Treatment:

Diagnostic Test: Breath Sampling and Analysis by PTR-MS