Development and Clinical Validation of Key Technologies for Non-invasive Breath Metabolic Fingerprinting for Large-scale Population Lipid Screening

NCT07546162 | Not Yet Recruiting

• 1 other identifier: KS2025237
• Study Type: observational
• Target: 280
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study collects exhaled breath condensate samples from healthy populations and hyperlipidemic populations, analyzes the characteristics of the exhaled metabolic lipid profile for early identification of people with abnormal blood lipids, verifies the feasibility and accuracy of a new gas detection method for screening abnormal blood lipids, and explores a simple, fast, and non-invasive method for screening abnormal blood lipids.

Conditions

Hyperlipidemia

Outcome Measures

Primary Outcomes (1)

• Sensitivity , specificity , Receiver Operating Characteristic Curve and Area Under Curve of mass spectrometry screening model for dyslipidemia

  Week1

Study Arms (1)

Hyperlipidemia

Diagnostic Test: Lipid Abnormality Mass Spectrometry Screening Model

Interventions

Lipid Abnormality Mass Spectrometry Screening Model DIAGNOSTIC_TEST

By analyzing the lipid profile in human breath, explore a simple, fast, and non-invasive method for screening dyslipidemia

Hyperlipidemia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Healthy population, population with hyperlipidemia

You may qualify if:

• Age ≥ 18 years
• Voluntarily sign the informed consent form

You may not qualify if:

• Patients with lung cancer, asthma, chronic obstructive pulmonary disease, cystic fibrosis, or acute respiratory distress syndrome
• Women during pregnancy or breastfeeding
• Patients with chronic kidney disease (GFR \<60 ml/min) or liver cirrhosis
• Individuals unable to cooperate in collecting exhaled breath samples

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Yan Yan

CONTACT

+861064456782; eva3321@sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: April 22, 2026
• Study Start: April 2, 2026
• Primary Completion: May 31, 2026
• Study Completion: May 31, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share