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Breath Test to Identify Metabolic Syndrome and Healthy Obesity

Tests a breath analysis method to tell metabolic syndrome from healthy obesity.

Key facts

Who runs it
I.M. Sechenov First Moscow State Medical University
Where
Moscow, RussiaSee the site
Trial code
Registry title
Breath Mass Spectrometry in Metabolic Syndrome and Metabolically Healthy Obesity
Status
Recruiting
People taking part
300 people, planned
Started
19 Sept 2024
Expected to end
30 Dec 2026
Type of study
Observational, 3 groups
Treatments tested
  • Breath Sampling and Analysis by PTR-MS
Record updated
9 January 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults in three groups: people with metabolic syndrome, people with obesity but otherwise healthy metabolism, and healthy controls. A breath test will be studied.

Age
Over 18 years
Sex
Men and women can join.
Disease stage
Group 1: metabolic syndrome by IDF 2006 criteria (large waist plus at least 2 of: high blood pressure, high triglycerides, low HDL cholesterol, high fasting glucose). Group 2: large waist (men 94 cm (37 in) or more, women 80 cm (31 in) or more) without the other metabolic syndrome signs. Group 3: normal BMI and no signs of metabolic syndrome.

Main reasons for not taking part

  • History of heart attack or stroke
  • Type 1 or type 2 diabetes
  • Lung (bronchopulmonary) disease
  • Current or past cancer
  • Pregnancy or breastfeeding

The registry criteria, word for word

Show all 19 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Patient refusal to continue participation in the study
  • Identification of any non-inclusion criteria after enrollment

Where in Russia

  • University Clinical Hospital №1, Sechenov UniversityMoscow, RussiaContact: Philipp KopylovTaking people

About the trial

What the trial wants to find out

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.

The 3 groups in the trial

  • Metabolic Syndrome Group

    100 patients diagnosed with Metabolic Syndrome according to International Diabetes Federation (IDF) 2006 criteria.

    Treatment: Breath Sampling and Analysis by PTR-MS

  • Metabolically Healthy Obesity Group

    100 patients with waist circumference ≥94 cm (men)/≥80 cm (women), but without other components of Metabolic Syndrome (hypertension, dyslipidemia, impaired fasting glucose).

    Treatment: Breath Sampling and Analysis by PTR-MS

  • Control Group

    100 individuals with normal BMI and no signs of Metabolic Syndrome.

    Treatment: Breath Sampling and Analysis by PTR-MS

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
The Capabilities of Exhaled Breath Mass Spectrometry in Identifying Metabolic Syndrome and Metabolically Healthy Obesity
Plain-language title
Breath Test to Identify Metabolic Syndrome and Healthy ObesityGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
9 January 2026