Breath Mass Spectrometry in Metabolic Syndrome and Metabolically Healthy Obesity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-19

Study Completion Date

2026-12-30

Brief Summary

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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.

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Detailed Description

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This study focuses on characterizing the volatilome - the complete set of volatile organic compounds in exhaled air - as a novel biomarker source for metabolic health assessment.

The study represents the first comprehensive attempt to compare volatilome signatures between metabolically healthy and unhealthy obesity phenotypes. Successful validation of this approach could establish breath analysis as a new diagnostic paradigm in metabolic medicine, enabling rapid, non-invasive screening and personalized treatment strategies for patients with obesity-related conditions.

Methodological innovations include real-time breath analysis capabilities and development of specialized machine learning algorithms for pattern recognition in complex mass spectrometry data. The findings are expected to contribute significantly to understanding metabolic pathway alterations in different obesity phenotypes.

Conditions

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Metabolic Syndrome Obesity & Overweight Metabolically Healthy Obesity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Metabolic Syndrome Group

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

Breath Sampling and Analysis by PTR-MS

Intervention Type DIAGNOSTIC_TEST

A single sample of exhaled breath will be collected from each participant during quiet breathing. The sample will be analyzed in real-time using Proton-Transfer-Reaction Time-of-Flight Mass Spectrometry (Compact PTR-TOF-MS 1000, Ionicon, Austria) to identify and quantify the spectrum of volatile organic compounds (VOCs).

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).

Breath Sampling and Analysis by PTR-MS

Intervention Type DIAGNOSTIC_TEST

A single sample of exhaled breath will be collected from each participant during quiet breathing. The sample will be analyzed in real-time using Proton-Transfer-Reaction Time-of-Flight Mass Spectrometry (Compact PTR-TOF-MS 1000, Ionicon, Austria) to identify and quantify the spectrum of volatile organic compounds (VOCs).

Control Group

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

Breath Sampling and Analysis by PTR-MS

Intervention Type DIAGNOSTIC_TEST

A single sample of exhaled breath will be collected from each participant during quiet breathing. The sample will be analyzed in real-time using Proton-Transfer-Reaction Time-of-Flight Mass Spectrometry (Compact PTR-TOF-MS 1000, Ionicon, Austria) to identify and quantify the spectrum of volatile organic compounds (VOCs).

Interventions

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Breath Sampling and Analysis by PTR-MS

A single sample of exhaled breath will be collected from each participant during quiet breathing. The sample will be analyzed in real-time using Proton-Transfer-Reaction Time-of-Flight Mass Spectrometry (Compact PTR-TOF-MS 1000, Ionicon, Austria) to identify and quantify the spectrum of volatile organic compounds (VOCs).

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

* 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.