Blow into this machine: a new breath test may spot hidden health risks
NCT ID NCT07330297
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is testing whether a breath test can identify metabolic syndrome and metabolically healthy obesity without needles or blood work. Researchers will analyze the air exhaled by 300 adults using a special mass spectrometry technique and teach a computer to recognize disease-specific breath patterns. If successful, this could lead to a quick, painless way to screen for these conditions.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 300 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2024
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The study population consists of adults (≥18 years) from three groups: 1) Patients with Metabolic Syndrome (IDF, 2005 criteria), 2) Patients with metabolically healthy obesity (BMI≥30, no metabolic abnormalities), and 3) Healthy controls (BMI\<25, no metabolic disorders).
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University Clinical Hospital №1, Sechenov University
RECRUITINGMoscow, Russia
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