Insulin Sensitivity/ResistanceNCT06766617
Assessment of Insulin Sensitivity in Healthy Adults by a 13C-glucose Breath Test : Method Development and Validation
A study testing 75 gr Glucose in people with Insulin Sensitivity/Resistance, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Insulin Sensitivity/Resistance
- What is being tested?
- 75 gr Glucose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteSwitzerland
- Study dates
- 29 Sep 2016to 30 Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male adults aged 18-40 Able to understand and to sign a written informed consent
Who cannot join
- 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)
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country.
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.
Read the 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.
- Conditions
- Insulin Sensitivity/Resistance
- Being tested
- 75 gr Glucose
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
75 gr GlucoseOther
Also called oral glucose intake
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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: 75 gr Glucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
1) To assess the within-subjects variability and overall repeatability of the 13C-glucose breath test
repeated measure of breath over the 3 visits.
Measured: 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.
repeated measure over the 3 visits of breath, plasma and CGM values
Measured: 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
Measured: 0 to 300 minutes, after oral adminstration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start29 Sep 2016
- Primary completion30 Oct 2016
- Study completion30 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin Sensitivity/ResistanceStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Monocentric, sequential open label
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06766617
- Sponsor's protocol ID
- 16.02.BIO
- Status last verified
- Jan 2025
- First submitted
- 22 Jul 2024
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No sharing planned
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Insulin Sensitivity in Healthy Adults by a 13C-glucose Breath Test : Method Development and Validation
- ClinicalTrials.gov ID
- NCT06766617
- Acronym / sponsor ID
- 16.02.BIO
- Conditions
- Insulin Sensitivity/Resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 29 Sep 2016 (actual)
- Primary completion
- 30 Oct 2016 (actual)
- Study completion
- 30 Oct 2016 (actual)
- First posted
- 9 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Monocentric, sequential open label
| Arm | Type | Receives |
|---|---|---|
| Glucose 75 Gr | Experimental | Other: 75 gr Glucose75g of anhydrous glucose dissolved in 375 ml of water (Vittel) mixed with 150mg of U-13C]-glucose (stable isotope from Eurisotope, France). |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy male adults aged 18-40 Able to understand and to sign a written informed consent
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 75 gr GlucoseAlso: oral glucose intake75g 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 | Glucose 75 Gr |
Primary outcome
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.
2 secondary outcomes
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
Repeatability of the continuous glucose monitoring system (CGM)
Time frame: 0 to 300 minutes, after oral adminstration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
- Individual participant dataSharing planned: No. No sharing planned
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 75 gr Glucose in people with Insulin Sensitivity/Resistance, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2025.