Insulin Sensitivity/Resistance
Conditions
Brief summary
The current research project aims to assess the insulin resistance (less sensitivity), from measures of insulin and glucose in response to a standard oral intake of glucose (standardized oral glucose tolerance test). For this, we wish to test and validate the method of glucose labelled 13-C (stable isotope) breath test in comparison with standardized methods to measure glucose and insulin. Comparative methods that will be used are measures of glycemia from venous blood withdrawal and continuous glucose measurement in the skin tissue (external face of the arm) using the Abbott's freestyle libre system. Repeatability and reliability of the 13-C glucose breath test will be checked from repeated measures over time.
Detailed description
The current research project aims to assess the insulin resistance (less sensitivity), from measures of insulin and glucose in response to a standard oral intake of glucose (standardized oral glucose tolerance test). For this, we wish to test and validate the method of glucose labelled 13-C (stable isotope) breath test in comparison with standardized methods to measure glucose and insulin. Comparative methods that will be used are measures of glycemia from venous blood withdrawal and continuous glucose measurement in the skin tissue (external face of the arm) using the Abbott's freestyle libre system. Repeatability and reliability of the 13-C glucose breath test will be checked from repeated measures over time.
Interventions
OTHER75 gr Glucose
75g of anhydrous glucose dissolved in 375 ml of water (Vittel) mixed with 150mg of U-13C\]-glucose (stable isotope from Eurisotope, France). will be orally taken
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Monocentric, sequential open label
Eligibility
Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy male adults aged 18-40 Able to understand and to sign a written informed consent
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1) To assess the within-subjects variability and overall repeatability of the 13C-glucose breath test | 0 to 300 minutes, after oral administration | repeated measure of breath over the 3 visits. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compare the results of breath test and CGM with the classical indexes of insulin resistance after an oral glucose challenge (OGTT) containing a small amount of [U13C]-glucose. | 0 to 300 minutes, after oral adminstration | repeated measure over the 3 visits of breath, plasma and CGM values |
| Repeatability of the continuous glucose monitoring system (CGM) | 0 to 300 minutes, after oral adminstration | repeated measure over the 3 visits of breath, plasma and CGM values |
Countries
Switzerland
Outcome results
None listed