The Daytime Circadian Rhythm in Exhaled Volatile Organic Compounds in People Living Without and Diabetes

Active, not recruiting

• Conditions: Diabetes Mellitus
• Interventions: Other: Standardized meal

• Registration Number: NCT05984979
• Lead Sponsor: University of Bern

Brief Summary

Exhaled volatile organic compounds will be measured during daytime with the goal to identifying circadian variability. The study incudes three subgroups: people without diabetes, people with type 1 diabetes, and people with type 2 diabetes. A total of 60 people will be recruited for the study.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-24
• Study First Submitted QC: 2023-08-02
• Study Start: 2023-08-07
• Study First Posted: 2023-08-09
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-04
• Last Update Posted: 2024-10-08
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
People with type 2 diabetes	Standardized meal	-
People without diabetes	Standardized meal	-
People with type 1 diabetes	Standardized meal	-

Primary Outcome Measures

Name	Time	Method
VOC Patterns over time as boxplots	During the study procedure (approximately 8 hours)	Box plots from selected VOC peaks over time.
VOC Patterns over time as gallery plots	During the study procedure (approximately 8 hours)	Gallery plots (3D visualization of retention index, drift time, ion current) from selected VOC peaks over time.

Secondary Outcome Measures

Name	Time	Method
Correlation between VOCs and subgroups	day 1 or 8 hours	Wilcoxon signed-rank test will be used to explore if the patterns in VOCs differ between subgroup: people without diabetes, people living with T1D, and people living with T2D
Capillary blood glucose	During the study procedure (approximately 8 hours)	Correlation between capillary blood glucose and VOCs
Correlation between VOCs in breath intestinal microbiota	day 1	Correlation between VOCs in breath and intestinal microbiota species abundance
Correlation between VOCs in breath oral microbiota	day 1	Correlation between VOCs in breath and oral microbiota species abundance

Trial Locations

Locations (1)

University of Bern; 🇨🇭 Bern, Switzerland