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

NCT ID: NCT05984979

Last Updated: 2025-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-07

Study Completion Date

2026-06-30

Brief Summary

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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

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Conditions

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Diabetes Mellitus

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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People without diabetes

Standardized meal

Intervention Type OTHER

The participants will receive a standardized meal for breakfast

People with type 1 diabetes

Standardized meal

Intervention Type OTHER

The participants will receive a standardized meal for breakfast

People with type 2 diabetes

Standardized meal

Intervention Type OTHER

The participants will receive a standardized meal for breakfast

Interventions

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Standardized meal

The participants will receive a standardized meal for breakfast

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role collaborator

DCB Research AG

OTHER

Sponsor Role collaborator

University of Bern

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lilian Witthauer, Prof.Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Bern

Locations

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University of Bern

Bern, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Lilian Witthauer

Role: CONTACT

+41 31 664 22 77

Facility Contacts

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Witthauer Lilian, Prof.Dr.

Role: primary

+41 31 664 22 77

Other Identifiers

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VOCircle

Identifier Type: -

Identifier Source: org_study_id

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