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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-29

Study Completion Date

2016-10-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Exogenous Glucose Oxidation Breath Test

NCT01846767

Diabetes Mellitus, Type 2

COMPLETED NA

A Study Using Breath Tests to Identify Patients at Risk for Gestational Diabetes

NCT07347262

Gestational Diabetes

COMPLETED

Validation of a 13C Glucose Breath Test Compared With the Euglycaemic Clamp Test

NCT04623320

Insulin Resistance Type 1 Diabetes

UNKNOWN

Monitoring Exhaled Breath to Noninvasively Detect Glycemic Events

NCT06893341

Diabetes Hyperglycemia Hypoglycemia

RECRUITING NA

Insulin Modelling Based on Plasma Glucose Measures Via a Minimally-Invasive Glucose Sensor

NCT06119035

PreDiabetes

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Insulin Sensitivity/Resistance

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SEQUENTIAL

Monocentric, sequential open label

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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).

Group Type EXPERIMENTAL

75 gr Glucose

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

oral glucose intake

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes