Actively Recruiting
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
Eligibility Criteria
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
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
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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