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

NCT06766617 | Completed

• 1 other identifier: 16.02.BIO
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Insulin Sensitivity/Resistance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• Repeatability of the continuous glucose monitoring system (CGM)

  0 to 300 minutes, after oral adminstration

Study Arms (1)

Glucose 75 Gr

EXPERIMENTAL

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

Interventions

75 gr Glucose OTHER

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

Also known as: oral glucose intake

Glucose 75 Gr

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: excluded hormonal variability of young female participants
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

Clinical innovation lab

Lausanne, Switzerland

Location

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Monocentric, sequential open label

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: January 9, 2025
• Study Start: September 29, 2016
• Primary Completion: October 30, 2016
• Study Completion: October 30, 2016
• Last Updated: January 9, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)