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RecruitingNCT05984979VOCircleUpdated Dec 8, 2025

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

An observational study in Diabetes Mellitus, sponsored by University of Bern. Recruiting at 1 site in Switzerland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-08.

Sponsored by University of Bern · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2026, 3 months ago, but the record still lists the study as recruiting.
  • Started Aug 2023; still recruiting 3 years 2 months later.
Study type
Observational
Model
Other
Time perspective
Other
Enrollment
60
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetes Mellitus

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03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.

This study's planned enrollment of 60 is below the median of 233 across 2,218 observational studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

University of Bern is the lead sponsor of 207 studies on the registry; 47 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

60 participants with the following subgroups: Subgroup 1: People without diabetes Subgroup 2: People diagnosed with T1D Subgroup 3: People diagnosed with T2D

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

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
05

Study design

Observational model
Other
Time perspective
Other
Enrollment
60 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • People without diabetes

    Other: Standardized meal

  • People with type 1 diabetes

    Other: Standardized meal

  • People with type 2 diabetes

    Other: Standardized meal

Interventions

  • OtherStandardized meal

    The participants will receive a standardized meal for breakfast

06

What researchers measure

Primary outcomes

  1. VOC Patterns over time as gallery plots

    Gallery plots (3D visualization of retention index, drift time, ion current) from selected VOC peaks over time.

    Time frame: During the study procedure (approximately 8 hours)

  2. VOC Patterns over time as boxplots

    Box plots from selected VOC peaks over time.

    Time frame: During the study procedure (approximately 8 hours)

Secondary outcomes

  1. Capillary blood glucose

    Correlation between capillary blood glucose and VOCs

    Time frame: During the study procedure (approximately 8 hours)

  2. Correlation between VOCs in breath intestinal microbiota

    Correlation between VOCs in breath and intestinal microbiota species abundance

    Time frame: day 1

  3. Correlation between VOCs in breath oral microbiota

    Correlation between VOCs in breath and oral microbiota species abundance

    Time frame: day 1

  4. Correlation between VOCs and subgroups

    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

    Time frame: day 1 or 8 hours

07

Study locations

1 of 1 sites recruiting
  • University of Bern
    Bern, 3010, Switzerland
    • Witthauer Lilian, Prof.Dr. · Contact · lilian.witthauer@unibe.ch · +41 31 664 22 77
    • Witthauer Lilian, Prof.Dr. · Principal investigator
    • Nicolier Cléo · Sub investigator
    Recruiting
08

References and documents

Publications

  • Nicolier C, Rothenbuhler M, Balmer ML, Witthauer L. 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. BMJ Open. 2026 Apr 8;16(4):e113892. doi: 10.1136/bmjopen-2025-113892. PubMed 41951262 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05984979
Lead sponsor
University of Bern
Collaborators
Insel Gruppe AG, University Hospital Bern, DCB Research AG
Responsible party
Sponsor
First posted
Aug 9, 2023
Start date
Aug 7, 2023
Primary completion
Jun 30, 2026 (estimated)
Completion
Jun 30, 2026 (estimated)
Last update
Dec 8, 2025

Study contacts

Lilian Witthauer
Contact
lilian.witthauer@unibe.ch
+41 31 664 22 77
Lilian Witthauer, Prof.Dr.
principal investigator · University of Bern

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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