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

The Capabilities of Exhaled Breath Mass Spectrometry in Identifying Metabolic Syndrome and Metabolically Healthy Obesity

This project will test whether a breath mass spectrometry test can tell apart adults with metabolic syndrome, adults with metabolically healthy obesity, and healthy-weight adults.

Quick facts

• Study type: Observational
• Enrollment: 300 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: I.M. Sechenov First Moscow State Medical University (Academic / other)
• Locations: 1 site (Moscow)
• Trial ID: NCT07330297 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults (over 18) who fit one of three groups: diagnosed metabolic syndrome by IDF 2006 criteria, metabolically healthy obesity (increased waist circumference without other metabolic syndrome features), or normal-weight healthy controls.

Not a fit: People with recent heart attack or stroke, advanced kidney disease (eGFR <30), familial hypercholesterolemia, active cardiovascular or significant lung disease, or those unable to provide informed consent are excluded and unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, this could lead to a rapid, non-invasive breath test to screen for metabolic syndrome and guide personalized care for people with obesity.

How similar studies have performed: Pilot breathomics studies have suggested volatile compound profiles can reflect metabolic states, but large-scale validated models distinguishing metabolically healthy versus unhealthy obesity remain limited and this comparison is novel.

Eligibility criteria

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 this trial is running

Moscow

• University Clinical Hospital №1, Sechenov University — Moscow, Russia (Recruiting)

Study contacts

• Study coordinator: Philipp Kopylov

Conditions Metabolic Syndrome; Obesity & Overweight; Metabolically Healthy Obesity; Breath Analysis; Volatile Organic Compounds; Proton-Transfer-Reaction Mass Spectrometry; Artificial Intelligence; Machine Learning