Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
NCT07330297

Breath Mass Spectrometry in Metabolic Syndrome and Metabolically Healthy Obesity

Led by I.M. Sechenov First Moscow State Medical University · Updated on 2026-01-09

300

Participants Needed

1

Research Sites

118 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

Breath Mass Spectrometry in Metabolic Syndrome and Metabolically Healthy Obesity

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age over 18 years
  • Signed informed consent
  • For Metabolic Syndrome group: diagnosis of Metabolic Syndrome by IDF 2006 criteria (waist circumference >94 cm for men / >80 cm for women plus at least two of the following: blood pressure 130/85 mmHg or antihypertensive therapy; triglycerides 1.7 mmol/L; HDL cholesterol <1.03 mmol/L for men / <1.29 mmol/L for women; fasting glucose 5.6 mmol/L)
  • For Metabolically Healthy Obesity group: waist circumference 94 cm for men / 80 cm for women, absence of other Metabolic Syndrome criteria (no hypertension, dyslipidemia, or impaired fasting glucose)
  • For Control group: normal body mass index (BMI) and no signs of Metabolic Syndrome
Not Eligible

You will not qualify if you...

  • Unable to provide informed consent
  • History of myocardial infarction or stroke
  • Chronic kidney disease stage 3B, 4, or 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 oncological diseases
  • Severe liver dysfunction or 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
  • Refusal to continue study participation
  • Identification of any exclusion criteria after enrollment

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

University Clinical Hospital №1, Sechenov University

Moscow, Russia

Actively Recruiting

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Research Team

P

Philipp Kopylov

CONTACT

A

Aida Gadzhiakhmedova

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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