Metabolic Syndrome Clinical Trials

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The Capabilities of Exhaled Breath Mass Spectrometry in Identifying Metabolic Syndrome and Metabolically Healthy Obesity

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Russian Federation
University Clinical Hospital №1, Sechenov University
RECRUITING
Moscow
Contact Information
Primary
Philipp Kopylov
kopylov_f_yu@staff.sechenov.ru
+7 (903) 687-72-64
Backup
Aida Gadzhiakhmedova
ai.kidman@mail.ru
+7 (989) 899-53-01
Time Frame
Start Date: 2024-09-19
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 300
Treatments
Metabolic Syndrome Group
100 patients diagnosed with Metabolic Syndrome according to International Diabetes Federation (IDF) 2006 criteria.
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).
Control Group
100 individuals with normal BMI and no signs of Metabolic Syndrome.
Related Therapeutic Areas
Sponsors
Leads: I.M. Sechenov First Moscow State Medical University

This content was sourced from clinicaltrials.gov