Assessment of Insulin Sensitivity in Healthy Adults by a 13C-glucose Breath Test : Method Development and Validation

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.

Study Overview

• Status: Completed
• Conditions: Insulin Sensitivity/Resistance
• Intervention / Treatment: Other: 75 gr Glucose

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.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Lausanne, Switzerland
    • Clinical Innovation Lab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Glucose 75 Gr; 75g of anhydrous glucose dissolved in 375 ml of water (Vittel) mixed with 150mg of U-13C]-glucose (stable isotope from Eurisotope, France).	Other: 75 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; Other Names: oral glucose intake

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1) To assess the within-subjects variability and overall repeatability of the 13C-glucose breath test	repeated measure of breath over the 3 visits.	0 to 300 minutes, after oral administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	repeated measure over the 3 visits of breath, plasma and CGM values	0 to 300 minutes, after oral adminstration
Repeatability of the continuous glucose monitoring system (CGM)	repeated measure over the 3 visits of breath, plasma and CGM values	0 to 300 minutes, after oral adminstration

Collaborators and Investigators

• Sponsor: Société des Produits Nestlé (SPN)

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2016
• Primary Completion (Actual): October 30, 2016
• Study Completion (Actual): October 30, 2016

Study Registration Dates

• First Submitted: July 22, 2024
• First Submitted That Met QC Criteria: January 8, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 8, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Immune System Diseases; Glucose Metabolism Disorders; Hyperinsulinism; Hypersensitivity; Insulin Resistance
• Other Study ID Numbers: 16.02.BIO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No sharing planned

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No