Daytime circadian patterns of exhaled volatile organic compounds in adults without and with type 1 and type 2 diabetes: protocol for an exploratory observational study

成人(包括无糖尿病者、1型糖尿病患者和2型糖尿病患者)呼出气挥发性有机化合物的昼夜节律模式:一项探索性观察研究方案

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Abstract

INTRODUCTION: Circadian regulation modulates metabolic and hormonal processes throughout the day, yet it remains unclear whether these diurnal fluctuations are reflected in exhaled volatile organic compound (VOC) profiles and whether such temporal patterns differ between individuals with and without diabetes. Previous breath analysis studies in diabetes have shown heterogeneous results, which may reflect differences in analytical approaches and the lack of standardised sampling times. METHODS AND ANALYSIS: This prospective, single-centre observational study examines daytime VOC dynamics from 08:00 to 16:00 among adults without diabetes, and individuals with type 1 diabetes or type 2 diabetes. 60 participants will complete one in-person visit with repeated breath measurements using a BreathSpec(®) gas chromatography-ion mobility spectrometry system (GC-IMS) device, capillary glucose testing, body composition assessment, questionnaires, and oral and stool microbiota sampling. A standardised breakfast is provided; subsequent meals follow structured timing but are not standardised. The primary outcome is temporal variation in VOC intensities. Secondary outcomes include between-group differences and associations with glucose levels, body composition and microbiota composition. Analyses will use established GC-IMS tools and exploratory multivariate approaches. ETHICS AND DISSEMINATION: Ethics approval was granted by the Ethics Committee of the Canton of Bern (BASEC 2023-01143). Results will be shared via peer-reviewed publications, conferences and lay summaries. TRIAL REGISTRATION NUMBER: NCT05984979.

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