NCT07330297Recruiting
Breath Mass Spectrometry in Metabolic Syndrome and Metabolically Healthy Obesity
The Capabilities of Exhaled Breath Mass Spectrometry in Identifying Metabolic Syndrome and Metabolically Healthy Obesity
Source: ClinicalTrials.gov · Last updated 9 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 300 (estimated)
- First submitted
- 29 Dec 2025
- Start date
- 19 Sept 2024
- Primary completion date
- 1 Jun 2026
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Diseases
- Obesity
- NCT number
- NCT07330297
What you commit to
- Study type: Observational
- Planned participants: 300
- From 19 Sept 2024 to the primary completion date, 1 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Patient refusal to continue participation in the study;
- Identification of any non-inclusion criteria after enrollment.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Clinical Hospital №1, Sechenov University Coordinator of this site? Confirm its status | Moscow | Russia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.