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
Descrizione riassuntiva dello studio
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)
Intervento studiato
Different glucose excursions through the administration of glucose solution (or a standardized meal) and insulin.
(BASEC)
Malattie studiate
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)
Criteri di esclusione
- 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)
Luogo dello studio
Berna
(BASEC)
Sponsor
Diabetes Center Berne
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Stefanie Hossmann
+41794217376
stefanie.hossmann@clutterdcberne.comDiabetes Center Berne
(BASEC)
Informazioni scientifiche
non disponibile
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica Berna
(BASEC)
Data di approvazione del comitato etico
21.08.2024
(BASEC)
ID di studio ICTRP
non disponibile
Titolo ufficiale (approvato dal comitato etico)
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)
Titolo accademico
non disponibile
Titolo pubblico
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Malattie studiate
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Intervento studiato
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Tipo di studio
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Disegno dello studio
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Criteri di inclusione/esclusione
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non disponibile
Endpoint primari e secondari
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Data di registrazione
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Inclusione del primo partecipante
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Sponsor secondari
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Contatti aggiuntivi
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ID secondari
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Risultati-Dati individuali dei partecipanti
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Ulteriori informazioni sullo studio
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Risultati dello studio
Riepilogo dei risultati
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Link ai risultati nel registro primario
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