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

Diabetes Mellitus Clinical Trial

— VOCircle  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05984979
• Other study ID #: VOCircle
• Status: Recruiting
• Start date: August 7, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: December 2023
• Source: University of Bern
• Contact: Cléo Nicolier
• Phone: +41 31 664 22 77
• Email: cleo.nicolier[@]unibe.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
Switzerland	University of Bern	Bern

Sponsors (3)

Lead Sponsor	Collaborator
University of Bern	DCB Research AG, Insel Gruppe AG, University Hospital Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VOC Patterns over time as gallery plots	Gallery plots (3D visualization of retention index, drift time, ion current) from selected VOC peaks over time.	During the study procedure (approximately 8 hours)
Primary	VOC Patterns over time as boxplots	Box plots from selected VOC peaks over time.	During the study procedure (approximately 8 hours)
Secondary	Capillary blood glucose	Correlation between capillary blood glucose and VOCs	During the study procedure (approximately 8 hours)
Secondary	Correlation between VOCs in breath intestinal microbiota	Correlation between VOCs in breath and intestinal microbiota species abundance	day 1
Secondary	Correlation between VOCs in breath oral microbiota	Correlation between VOCs in breath and oral microbiota species abundance	day 1
Secondary	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	day 1 or 8 hours