Breath Mass Spectrometry in Metabolic Syndrome and Metabolically Healthy Obesity
Recruiting · NCT07330297 · Observational (researchers observe without assigning treatment) · Lead sponsor: I.M. Sechenov First Moscow State Medical University
View the official record on ClinicalTrials.gov →Interventions studied
Breath Sampling and Analysis by PTR-MS
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 it is running
1 location listed.
- University Clinical Hospital №1, Sechenov University - Moscow, Russia