Clinical trial NCT06621030: Evaluation of Correlations Between Volatile Organic Compounds and Venous Blood Glucose in Subjects With Type 2 Diabetes
Official title: Evaluation of Correlations Between Volatile Organic Compounds (VOCs) Spectra Measured With GC-IMS and MOx-sensors and Venous Blood Glucose in Subjects With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Volatile Organic Compounds
Gas Chromatography - Ion Mobility Spectrometry
Rates of change of glucose values
Breath-analysis
Hyperglycaemia
Hypoglycaemia
Glucose excursions
Lead sponsor: BOYDSENSE
Sponsor class: INDUSTRY
Collaborators: name: Insel Gruppe AG, University Hospital Bern
name: DCB Research AG
First posted: 2024-10-01
Enrollment: 15
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The intervention consists of inducing different glycaemic states in people with diabetes.
Primary purpose: TREATMENT

Brief summary: The goal of this study is to evaluate correlations between VOCs in the breath and venous blood glucose values in various glycaemic states in people living with Type 2 Diabetes. VOCs are measured with a gold-standard GC-IMS device and a prototype of a novel breath analyzer. Participants will be exposed to different blood glucose levels at different rates of change by administering glucose solution and insulin and by a meal challenge.

Detailed description: The research project aims to expand the understanding of correlations between VOCs in the breath and venous blood glucose levels in non-insulin-dependent people with Type 2 Diabetes. To better understand correlations, the subjects are exposed to hyperglycaemic, euglycaemic and hyposglcycaemic states at different rates of change by applying a hand clamp procedure, and the VOCs are compared after a standardized meal and the same excursion by applying a hand clamp procedure. Inter- and intraparticipant variability as well as the timing of changes in the VOC spectra compared to changes in the glucose values are of interest. Secondarily, the feasibility of estimating glycaemic states with a prototype of a novel breath analyzer is being investigated.

Eligibility criteria: Inclusion Criteria:

* Signed written informed consent
* T2D treated with one or more oral anti-diabetic drugs (incl GLP-1 and/or GIP)
* 10 years since T2D diagnosis
* HbA1c ≤8% (HbA1c based on last measurement by treating physician but not older than 120 days)
* Willingness to undergo study procedures
* Age 45 -70 years (inclusive)

Exclusion Criteria:

* Pregnancy and/or lactation period
* Currently on chronic or occasional treatment with pulmonary drugs
* Insulin dependency
* Smoking (last cigarette within the last six months)
* BMI above 30 kg/m²
* Lp(a) above 125 nmol/l
* LDL not in the individual target range of an earlier cholesterol goal according ESC guideline 2021 (LDL based on last measurement by treating physician but not older than 30 days)
* Irregular 12-lead ECG or increased carotid plaque burden based on a three-point sonography. Both examinations are performed and evaluated according to the investigator's judgment.
* History of, or manifested, cardiovascular diseases
* Medical history of epilepsy or other neurological disease associated with seizure events
* Known sensitivity to medical grade adhesives
* Comorbidities that are suspected to alter the VOC spectra
* Participation in another investigation with an investigational drug within the 30 days preceding and during the present investigation
* Not able to understand, write or read German

Primary outcomes:
measure: VOC spectra
timeFrame: 6-8 hour study visit
Secondary outcomes:
measure: Inter-Participant VOC Variability
timeFrame: 6-8 hour study visit
measure: Intra-Participant VOC Variability
timeFrame: 6-8 hour study visit
measure: MIB VOC Spectra Analysis
timeFrame: 6-8 hour study visit
measure: VOC Spectra Response Time
timeFrame: 6-8 hour study visit
measure: Comparison of meal vs clamp induced VOC changes
timeFrame: 6-8 hour study visit
Other outcomes:
Locations:
Study officials:
affiliation: BOYDSense SAS
name: Frank Flacke, Dr
role: STUDY_CHAIR
affiliation: Universitätsklinik für Diabetologie, Endokrinologie, Ernährungsmedizin & Metabolismus (UDEM)
name: Markus Laimer, Prof
role: PRINCIPAL_INVESTIGATOR
References: