Type 2 Diabetes
Conditions
Keywords
Volatile Organic Compounds, Glucose excursions, Rates of change of glucose values, Hyperglycaemia, Hypoglycaemia, Gas Chromatography - Ion Mobility Spectrometry, Euglycaemia, Breath-analysis
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.
Interventions
DEVICEMIB Breath Analyzer
Going through visit-specific blood glucose excursions by the administration of glucose and insulin (clamp), monitoring physiological processes, and measuring reference blood glucose values and VOC measurements in the breath using a GC-IMS and the MIBs (investigational devices). Going through visit-specific blood glucose excursions by consuming a standardized meal, monitoring physiological processes, and measuring reference blood glucose values and VOC measurements in the breath using a GC-IMS and the MIBs (investigational devices) Imitating the glucose excursion from the meal excursion by infusing glucose and insulin (clamp), monitoring physiological processes, and measuring reference blood glucose values and VOC measurements in the breath using a GC-IMS and the MIBs (investigational devices).
Sponsors
Insel Gruppe AG, University Hospital Bern
BOYDSENSE
DCB Research AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
The intervention consists of inducing different glycaemic states in people with diabetes.
Eligibility
Sex/Gender
ALL
Age
45 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VOC spectra | 6-8 hour study visit | Primary outcome focuses on VOC spectra (measured with the GC-IMS) across varying intravenous blood glucose levels |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inter-Participant VOC Variability | 6-8 hour study visit | Evaluation of VOC spectral differences measured with the GC-IMS among participants under identical glycemic states. |
| Intra-Participant VOC Variability | 6-8 hour study visit | Comparison of VOC spectral differences measured with the GC-IMS within the same participant across different glycemic states. |
| MIB VOC Spectra Analysis | 6-8 hour study visit | Investigation of VOC spectra (measured with the MIB) in diverse intravenously measured glycemic states. |
| VOC Spectra Response Time | 6-8 hour study visit | Assessment of the delay in VOC spectral shifts relative to changes in venous glucose from fluctuating to stable states at different change rates. |
| Comparison of meal vs clamp induced VOC changes | 6-8 hour study visit | Analysis of VOC spectral differences between natural post-meal glucose increases and clamp-induced glucose elevations measured with the GC-IMS. |
Countries
Switzerland
Outcome results
None listed