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

The Daytime Circadian Rhythm in Exhaled Volatile Organic Compounds in People Living Without and With Type 1 and 2 Diabetes: an Exploratory Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05984979
Acronym
VOCircle
Enrollment
60
Registered
2023-08-09
Start date
2023-08-07
Completion date
2026-06-30
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

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.

Interventions

The participants will receive a standardized meal for breakfast

Sponsors

Insel Gruppe AG, University Hospital Bern
CollaboratorOTHER
DCB Research AG
CollaboratorOTHER
University of Bern
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Subgroup 1: * Age 18 or older * HbA1c below 6.5% * Written informed consent Subgroup 2: * Age 18 or older * T1D (Type 1 diabetes) with MDI (multiple daily injection) or CSII (Continuous subcutaneous insulin infusion therapy) therapy \>1 year * Written informed consent Subgroup 3 * Age 18 or older * T2D (Type 2 diabetes) with oral antidiabetic medication or insulin therapy * Written informed consent

Exclusion criteria

* Pregnancy or breastfeeding * Smoking (last cigarette less than 6 months ago) * Any chronical lung and intestinal disease diagnosis (such as intestinal bowel disease (IBD); asthma; COPD (chronic obstructive pulmonary disease); lung cancer, …) * Coeliac disease * Lactose and fructose intolerance * Any acute disease diagnosis (such as viral or bacterial infection) * Drinking habit of more than four units of alcohol per day * Current inhaled medicines treatments * Antibiotic treatment in the previous 4 months

Design outcomes

Primary

MeasureTime frameDescription
VOC Patterns over time as gallery plotsDuring the study procedure (approximately 8 hours)Gallery plots (3D visualization of retention index, drift time, ion current) from selected VOC peaks over time.
VOC Patterns over time as boxplotsDuring the study procedure (approximately 8 hours)Box plots from selected VOC peaks over time.

Secondary

MeasureTime frameDescription
Capillary blood glucoseDuring the study procedure (approximately 8 hours)Correlation between capillary blood glucose and VOCs
Correlation between VOCs in breath intestinal microbiotaday 1Correlation between VOCs in breath and intestinal microbiota species abundance
Correlation between VOCs in breath oral microbiotaday 1Correlation between VOCs in breath and oral microbiota species abundance
Correlation between VOCs and subgroupsday 1 or 8 hoursWilcoxon 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

Countries

Switzerland

Contacts

Primary ContactLilian Witthauer
lilian.witthauer@unibe.ch+41 31 664 22 77

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 10, 2026