Evaluation of Correlations Between Volatile Organic Compounds and Venous Blood Glucose in Subject… (NCT07147010) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Correlations Between Volatile Organic Compounds and Venous Blood Glucose in Subjects With Type 2 Diabetes
Switzerland20 participantsStarted 2024-10-01
Plain-language 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.
Who can participate
Age range45 Years – 70 Years
SexALL
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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