Breath Mass Spectrometry in Metabolic Syndrome and Metabolically Healthy Obesity
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorI.M. Sechenov First Moscow State Medical University
About this trial
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.
Eligibility criteria
Qualifiers
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.
Inability to provide informed consent;
Disqualifiers
Patient refusal to continue participation in the study;
Identification of any non-inclusion criteria after enrollment.
Trial design
Treatments tested in this trial
- Breath Sampling and Analysis by PTR-MS
Treatment groups
300 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov