Ignite Creation Date:
2024-10-25 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06621030
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-25
Brief Title:
Evaluation of Correlations Between Volatile Organic Compounds and Venous Blood Glucose in Subjects With Type 2 Diabetes
Sponsor:
None
Organization:
None
Study Overview
Official 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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Evo
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None