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

Sponsor
University of Bern (Other)
Overall Status
Recruiting
CT.gov ID
NCT05984979
Collaborator
Insel Gruppe AG, University Hospital Bern (Other), DCB Research AG (Other)
60
Enrollment
1
Location
10.9
Anticipated Duration (Months)
5.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Standardized meal

Study Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Other
Time Perspective:
Other
Official Title:
The Daytime Circadian Rhythm in Exhaled Volatile Organic Compounds in People Living Without and With Type 1 and 2 Diabetes: an Exploratory Study
Anticipated Study Start Date :
Aug 2, 2023
Anticipated Primary Completion Date :
Jun 30, 2024
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

Arm Intervention/Treatment
People without diabetes

Other: Standardized meal
The participants will receive a standardized meal for breakfast
People with type 1 diabetes

Other: Standardized meal
The participants will receive a standardized meal for breakfast
People with type 2 diabetes

Other: Standardized meal
The participants will receive a standardized meal for breakfast

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. VOC Patterns over time as boxplots [During the study procedure (approximately 8 hours)]

    Box plots from selected VOC peaks over time.

Secondary Outcome Measures

  1. Capillary blood glucose [During the study procedure (approximately 8 hours)]

    Correlation between capillary blood glucose and VOCs

  2. Correlation between VOCs in breath intestinal microbiota [day 1]

    Correlation between VOCs in breath and intestinal microbiota species abundance

  3. Correlation between VOCs in breath oral microbiota [day 1]

    Correlation between VOCs in breath and oral microbiota species abundance

  4. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Bern Bern Switzerland 3010

Sponsors and Collaborators

  • University of Bern
  • Insel Gruppe AG, University Hospital Bern
  • DCB Research AG

Investigators

  • Principal Investigator: Lilian Witthauer, Prof.Dr., University of Bern

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Bern
ClinicalTrials.gov Identifier:
NCT05984979
Other Study ID Numbers:
  • VOCircle
First Posted:
Aug 9, 2023
Last Update Posted:
Aug 9, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Diabetes Mellitus

Study Results

No Results Posted as of Aug 9, 2023