Clinical trial NCT06766617: Assessment of Insulin Sensitivity in Healthy Adults by a 13C-glucose Breath Test : Method Development and Validation
Official title: Assessment of Insulin Sensitivity in Healthy Adults by a 13C-glucose Breath Test : Method Development and Validation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Sensitivity/Resistance
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2025-01-09
Enrollment: 7
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Monocentric, sequential open label
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

Healthy male adults aged 18-40 Able to understand and to sign a written informed consent

Exclusion Criteria:

* EXCLUSION CRITERIA
* Known type 1 or type 2 diabetes, by anamnesis
* Family history of type 2 diabetes (parents)
* History of gestational diabetes
* Any other metabolic disease possibly impacting the postprandial glucose and insulin response (anamnesis)
* Any medication impacting the energetic metabolism, to the opinion of the investigator
* Pregnant or lactating women (anamnesis)
* Smoking
* Allergy or intolerance to any food or compound used in this study
* Currently following a strict exercise program (more than three times per week) in order to either lose weight, gain muscle or reach competition standards for a chosen sport
* Having given blood in the past three months or willing to give blood in the 3 months following the completion of the study
* Currently participating or having participated in another clinical trial during the past month.
* Volunteer who cannot be expected to comply with the protocol

Primary outcomes:
measure: 1) To assess the within-subjects variability and overall repeatability of the 13C-glucose breath test
timeFrame: 0 to 300 minutes, after oral administration
Secondary outcomes:
measure: 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.
timeFrame: 0 to 300 minutes, after oral adminstration
measure: Repeatability of the continuous glucose monitoring system (CGM)
timeFrame: 0 to 300 minutes, after oral adminstration
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Clinical innovation lab
Study officials:
References: