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NCT Number: NCT06766617

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.

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Key information

Conditions

Insulin Sensitivity/Resistance Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Clinical innovation lab

Lausanne, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: oral glucose intake

Primary outcomes

  1. 1) To assess the within-subjects variability and overall repeatability of the 13C-glucose breath test

    Time frame: 0 to 300 minutes, after oral administration

    repeated measure of breath over the 3 visits.

Secondary outcomes

  1. 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.

    Time frame: 0 to 300 minutes, after oral adminstration

    repeated measure over the 3 visits of breath, plasma and CGM values

  2. Repeatability of the continuous glucose monitoring system (CGM)

    Time frame: 0 to 300 minutes, after oral adminstration

    repeated measure over the 3 visits of breath, plasma and CGM values

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jan 9, 2025
Registry last updated
Jan 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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