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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- VOC spectra
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
VOC spectra
时间窗: 6-8 hour study visit
Primary outcome focuses on VOC spectra (measured with the GC-IMS) across varying intravenous blood glucose levels
次要结局
- Inter-Participant VOC Variability(6-8 hour study visit)
- Intra-Participant VOC Variability(6-8 hour study visit)
- MIB VOC Spectra Analysis(6-8 hour study visit)
- VOC Spectra Response Time(6-8 hour study visit)
- Comparison of meal vs clamp induced VOC changes(6-8 hour study visit)