Evaluation of Correlations Between Volatile Organic Compounds and Venous Blood Glucose in Subjects With Type 2 Diabetes

Not Applicable

Not yet recruiting

• Conditions: Type 2 Diabetes
• Interventions: Device: MIB Breath Analyzer

• Registration Number: NCT06621030
• Lead Sponsor: BOYDSENSE

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.

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-25
• Study First Submitted QC: 2024-09-27
• Last Update Submitted: 2024-09-27
• Study Start: 2024-10-01
• Study First Posted: 2024-10-01
• Last Update Posted: 2024-10-01
• Primary Completion: 2025-03-30
• Study Completion: 2025-03-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	MIB Breath Analyzer	Exposure to various glycaemic states at different rates of change by administering glucose solution, insulin, or a standardized meal.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.