Evaluation of the correlation between the spectra of volatile organic compounds (VOCs), measured with GC-IMS and MOx sensors, and the venous blood glucose level in individuals with type 2 diabetes
Résumé de l'étude
The main objective of this study is to identify certain particles in the exhaled air that are associated with different blood glucose levels. Highly specialized breath analysis devices are used to accurately measure the composition of the exhaled air. These measurement results are then compared with the blood glucose levels of participants with type 2 diabetes. Participants complete five visits, during which four visits involve different glucose trajectories (increasing and decreasing) through the administration of liquid sugar (to raise the level) and insulin (to lower the level). During these visits, blood glucose values and the composition of the exhaled air are regularly recorded. The study examines both differences between individual visits of the same person and between different participants. It analyzes how quickly changes in blood glucose can be detected in the exhaled air, how different rates of blood glucose change affect the results, and whether it makes a difference if participants have eaten or if liquid sugar has been administered. Each visit includes monitoring of vital signs, safety checks, and recording of blood glucose values and exhaled air data. The study spans ten months, includes 15 participants, and is scheduled to be conducted from June 2024 to March 2025.
(BASEC)
Intervention étudiée
Different glucose excursions through the administration of glucose solution (or a standardized meal) and insulin.
(BASEC)
Maladie en cours d'investigation
Type 2 Diabetes
(BASEC)
- Signed written informed consent T2D treated with one or more oral antidiabetic agents (including GLP-1 and/or GIP) - Less than 16 years since T2D diagnosis - HbA1c ≤ 8% (HbA1c based on the last measurement by the treating physician, but not older than 120 days) - Willingness to undergo all study procedures (sub-study 1-3) - Age 45 - 70 years (inclusive) (BASEC)
Critères d'exclusion
- Pregnancy and/or breastfeeding - Current chronic or occasional treatment with lung medications - Smoking (last cigarette within the last six months) - BMI over 35 kg/m² - Lp(a) over 125 nmol/l - LDL not within the individual target range of a previous cholesterol target according to ESC guidelines 2021 (LDL based on the last measurement by the treating physician, but not older than 30 days) - Irregular 12-lead ECG or increased arterial plaque burden, based on a three-point ultrasound. Both examinations are performed and assessed at the discretion of the investigator. - History or manifest cardiovascular disease - Medical history of epilepsy or other neurological disorders associated with seizure events - Known sensitivity to medical adhesives - Comorbidities that are likely to alter the VOC spectra - Participation in another investigation with an investigational drug within 30 days prior to and during the current investigation - Limited German or English language skills (BASEC)
Lieu de l’étude
Berne
(BASEC)
Sponsor
Diabetes Center Berne
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Stefanie Hossmann
+41794217376
stefanie.hossmann@clutterdcberne.comDiabetes Center Berne
(BASEC)
Informations scientifiques
non disponible
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale d'éthique de Berne
(BASEC)
Date d'approbation du comité d'éthique
21.08.2024
(BASEC)
Identifiant de l'essai ICTRP
non disponible
Titre officiel (approuvé par le comité d'éthique)
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 (BASEC)
Titre académique
non disponible
Titre public
non disponible
Maladie en cours d'investigation
non disponible
Intervention étudiée
non disponible
Type d'essai
non disponible
Plan de l'étude
non disponible
Critères d'inclusion/exclusion
non disponible
non disponible
Critères d'évaluation principaux et secondaires
non disponible
non disponible
Date d'enregistrement
non disponible
Inclusion du premier participant
non disponible
Sponsors secondaires
non disponible
Contacts supplémentaires
non disponible
ID secondaires
non disponible
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
non disponible
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible