Healthy people, people with diabetes, people with obesity
Conditions
Interventions
Group 1: Healthy adults aged 18-70 years (Body-Mass-Index 18.0-27.0 kg/m²) will undergo a one-time mixed meal test. Postprandial blood parameters will be measured using optoacoustic spectroscopy in co
Sponsors
Institut für Klinische Ernährungsmedizin
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: • Controls: 30 healthy participants, aged 18-70 years, measured BMI 18.0-27.0 kg/m² • Cohort with T2D: 30 participants aged 18-70 years, with a self-reported non-insulin dependent T2D without complications (no prediabetes or insulin dependency), measured BMI 18.0-29.90 kg/m² • Cohort with obesity: 30 participants aged 18-70 years with a measured BMI of 30.0-45.0 kg/m² • All three groups: Signed and dated informed consent form, and willingness to follow the study procedures
Exclusion criteria
Exclusion criteria: a. Medical conditions: • Anemia • Type 1 Diabetes • Severe cardiovascular diseases • Active cancer (or in remission) • Severe active/chronic infections and/or inflammations • Skin conditions or injuries that could worsen due to the OA technology or that could interfere with readings • Fasting blood glucose of > 140 mg/dl • Other (depending on by case decision by the study`s physician) b. Others: • Pregnancy and lactation • Carrier of pacemakers • Blood donation or transfusion in the last 3 months • Non-compliance with pre-test requirements • Refusal of participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the feasibility of the novel optoacustic technology in predicting baseline and postprandial blood glucose levels across dynamic ranges after an oral glucose and lipid tolerance test (OGLTT) in healthy adults (n=30), in people with diabetes type 2 (T2D) (n=30) and in people with obesity (n=30) compared to the gold standard laboratory-based reference method (venous blood). The endpoint is quantified by the mean absolute relative difference (MARD), and the median absolute relative difference (MedARD), and is visualized by a Clarke error grid as a primary endpoint. | — |
Secondary
| Measure | Time frame |
|---|---|
| • To evaluate the feasibility of the novel optoacustic technology in predicting baseline and post-prandial blood glucose levels after an OGLTT in healthy adults (n=30) and people with T2D (n=30) and obesity (n=30), compared to conventional devices (glucometer, CGM) as reference. The endpoint is quantified by MARD, MedARD, and is visualized by a Clarke error grid as a secondary endpoint. • To evaluate the feasibility of the novel optoacustic technology in predicting baseline and post-prandial blood glucose levels after an OGLTT in healthy adults (n=30), as well as in people with T2D (n=30) and obesity (n=30), compared to reference values (lab-based method, glucometer, CGM) using ISO 15197:2013 (Chapter 6.3.3). The endpoint is quantified by MARD, MedARD, and is visualized by a Clarke error grid as a secondary endpoint. • To perform bias analysis to detect systematic measurement differences between the novel optoacustic technology readings and all other reference values (Bland-Altman plots). • To evaluate if the novel optoacustic technology can predict baseline and postprandial blood lac-tate and lipid levels after an OGLTT compared to the gold standard laboratory-based ref-erence method (venous blood), and to conventional devices (rapid tester) as reference. • To document the frequency and type of adverse events (AE) and adverse device events (ADE). | — |
Countries
Germany
Contacts
Public ContactChristina Holzapfel
Institut für Klinische Ernährungsmedizin, TUM Klinikum, TUM Campus im Olympiapark
Outcome results
None listed