Evaluation of Correlations Between Volatile Organic Compounds and Venous Blood Glucose in Subjects With Type 2 Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MIB Breath Analyzer.
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes. Basic parameters: 45 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Device MIB Breath Analyzer
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 an
Primary outcome measures
- VOC spectra [Time frame: 6-8 hour study visit]
Secondary outcome measures (5)
- Inter-Participant VOC Variability [Time frame: 6-8 hour study visit]
- Intra-Participant VOC Variability [Time frame: 6-8 hour study visit]
- MIB VOC Spectra Analysis [Time frame: 6-8 hour study visit]
- VOC Spectra Response Time [Time frame: 6-8 hour study visit]
- Comparison of meal vs clamp induced VOC changes [Time frame: 6-8 hour study visit]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06621030 · Evo Study