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NCT Number: NCT06621030

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperglycemia Hypoglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Age range

45 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MIB Breath Analyzer

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).

Primary outcomes

  1. VOC spectra

    Time frame: 6-8 hour study visit

    Primary outcome focuses on VOC spectra (measured with the GC-IMS) across varying intravenous blood glucose levels

Secondary outcomes

  1. Inter-Participant VOC Variability

    Time frame: 6-8 hour study visit

    Evaluation of VOC spectral differences measured with the GC-IMS among participants under identical glycemic states.

  2. Intra-Participant VOC Variability

    Time frame: 6-8 hour study visit

    Comparison of VOC spectral differences measured with the GC-IMS within the same participant across different glycemic states.

  3. MIB VOC Spectra Analysis

    Time frame: 6-8 hour study visit

    Investigation of VOC spectra (measured with the MIB) in diverse intravenously measured glycemic states.

  4. VOC Spectra Response Time

    Time frame: 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.

  5. Comparison of meal vs clamp induced VOC changes

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Stefanie Hossmann, MSc

CONTACT

[email protected]

041794217376

Sponsors and collaborators

Lead sponsor

BOYDSENSE

Industry

Collaborators

  • DCB Research AG
  • Insel Gruppe AG, University Hospital Bern

Registry information

Official study 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

Acronym: Evo

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 1, 2024
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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