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

Nestlé

Status: Completed

Conditions: Insulin Sensitivity/Resistance

Treatments: Other: 75 gr Glucose

Study type: Interventional

Funder types: Industry

Identifiers

NCT06766617

16.02.BIO

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7 patients

Sex: Male

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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7 participants in 1 patient group

Glucose 75 Gr

Experimental group

Description:

75g of anhydrous glucose dissolved in 375 ml of water (Vittel) mixed with 150mg of U-13C\]-glucose (stable isotope from Eurisotope, France).

Treatment:

Other: 75 gr Glucose