Actively Recruiting
The Capabilities of Exhaled Breath Mass Spectrometry in Identifying 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
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new non-invasive way to diagnose metabolic conditions like Metabolic Syndrome (MetS) and Metabolically Healthy Obesity (MHO) by analyzing exhaled breath. The study aims to identify different volatile organic compounds (VOCs) in the breath of 300 participants across three groups: MetS patients, MHO patients, and healthy individuals. This approach uses advanced mass spectrometry combined with machine learning to better understand metabolic differences and may help improve diagnosis and treatment in metabolic medicine. Participants will provide a single breath sample analyzed in real-time using Proton-Transfer-Reaction Time-of-Flight Mass Spectrometry (PTR-TOF-MS). The study groups include 100 people with Metabolic Syndrome, 100 with metabolically healthy obesity, and 100 healthy controls with normal body weight. The study will develop and validate a machine learning model to classify these metabolic states based on the breath analysis. During the study, researchers will collect breath samples and analyze VOC profiles to measure how accurately the model can distinguish metabolic conditions. They will assess model sensitivity, specificity, and overall accuracy using the area under the ROC curve. The study also plans to identify specific VOC patterns associated with different metabolic states. Participation involves one breath collection session, and the study will complete analysis within about one year after all data are collected.
CONDITIONS
Brief 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 including waist circumference over 94 cm (men) or 80 cm (women) plus at least two other criteria
- For Metabolically Healthy Obesity group: Waist circumference at least 94 cm (men) or 80 cm (women) without other Metabolic Syndrome components
- For Control group: Normal body mass index 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 with eGFR less than 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 such as severe dementia or schizophrenia
- Comorbid conditions with life expectancy less than one year
- Patient refusal to continue participation
- Identification of any exclusion criteria after enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single time point
Participants provide a single exhaled breath sample during quiet breathing, which is analyzed in real-time using Proton-Transfer-Reaction Time-of-Flight Mass Spectrometry to identify volatile organic compounds.
1 visit (in-person)
Duration - Up to 1 year
Data from breath analysis is processed and used to validate machine learning models for metabolic health assessment over the study period.
No additional visits required
Trial Site Locations
Total: 1 location
1
University Clinical Hospital №1, Sechenov University
Moscow, Russia
Actively Recruiting
Research Team
P
Philipp Kopylov
A
Aida Gadzhiakhmedova
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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