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

NCT ID: NCT06621030

Last Updated: 2024-10-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2025-03-30

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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single Arm

Exposure to various glycaemic states at different rates of change by administering glucose solution, insulin, or a standardized meal.

Group Type: EXPERIMENTAL

MIB Breath Analyzer

Intervention Type: DEVICE

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).

Interventions

MIB 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).

Intervention Type: DEVICE

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: collaborator

DCB Research AG

OTHER

Sponsor Role: collaborator

BOYDSENSE

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frank Flacke, Dr

Role: STUDY_CHAIR

BOYDSense SAS

Markus Laimer, Prof

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinik für Diabetologie, Endokrinologie, Ernährungsmedizin & Metabolismus (UDEM)

Central Contacts

Stefanie Hossmann, MSc

Role: CONTACT

stefanie.hossmann@dcberne.com

041794217376

Other Identifiers

Evo Study

Identifier Type: -

Identifier Source: org_study_id