Insulin ResistanceBRECLAIRNCT04623320
Validation of a 13C Glucose Breath Test Compared With the Euglycaemic Clamp Test
An observational study of Insulin Resistance and Type 1 Diabetes, run by University Hospital, Antwerp at 1 site in Belgium.
Trial summary
Insulin resistance can be assessed by the euglycaemic clamp technique. To date, this is the golden standard, but it is not suited for clinical practice. A 13C glucose breath test will be tested as a valid alternative. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insulin Resistance, Type 1 Diabetes
- What is being tested?
- euglycaemic clamp test and 13C glucose breath test
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- 27 Oct 2020to 31 Mar 2023
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Type 1 diabetes subjects from the research facility's outpatient clinic.
Who may be able to join
- Adult type 1 diabetes patients
- 25/50 subjects with confirmed NAFLD (using ultrasound criteria)
Who cannot join
- pregnancy
- gastric bypass surgery
- cirrhosis
- secondary cause of liver steatosis present
- any cause which makes a 4-hour clamp impossible
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Antwerp University Hospital
Antwerp, 2650
Christophe De Block, M.D., PhD
About this study
Official title: Validation of a 13C Glucose Breath Test to Quantify Insulin Resistance in Type 1 Diabetes Mellitus Compared With the Euglycaemic Clamp Test
Insulin resistance can be assessed by the euglycaemic clamp technique. To date, this is the golden standard, but it is not suited for clinical practice. A 13C glucose breath test will be tested as a valid alternative. The curve of the exhaled 13C CO2 as a function of glucose metabolism can be correlated to the curve of the glucose disposal rate obtained via the clamp technique.
Read the detailed description
The hyperinsulinemic-euglycemic clamp technique is the golden standard to assess insulin resistance in type 1 diabetes subjects. The plasma insulin concentration is acutely raised and maintained at 100 μU/ml by a continuous infusion of insulin. Meanwhile, the plasma glucose concentration is held constant at basal levels by a variable glucose infusion. When the steady-state is achieved, the glucose infusion rate equals glucose uptake by all the tissues in the body and is therefore a measure of tissue insulin sensitivity.
These data will be compared with the results of a 13C glucose breath test. Breath tests using 13C substrates are based on the principle that 13C CO2 in the exhaled breath can be measured as a metabolic tracer.
Breath testing has a major advantage over the clamp test in that it can be performed non-invasively and repeatedly without necessary supervision by medical staff.
- Conditions
- Insulin Resistance, Type 1 Diabetes
- Being tested
- euglycaemic clamp test, 13C glucose breath test
- Keywords
- insulin resistance, type 1 diabetes, euglycaemic clamp, breath test
- Medical subject headings
- Insulin Resistance, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
euglycaemic clamp testDiagnostic test
clamp test (golden standard) to determine insulin resistance
13C glucose breath testDiagnostic test
13C glucose breath test to compare with the golden standard
| Study group | Role | What they receive |
|---|---|---|
| NAFLD+T1DM+ | Subjects with type 1 diabetes and ultrasound-defined NAFLD Receives: Diagnostic Test: euglycaemic clamp test; Diagnostic Test: 13C glucose breath test | |
| NAFLD-T1DM+ | Subjects with type 1 diabetes without ultrasound-defined NAFLD Receives: Diagnostic Test: euglycaemic clamp test; Diagnostic Test: 13C glucose breath test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of the 13C breath test with the golden standard
sensitivity and specificity analysis using linear regression
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start27 Oct 2020
- Primary completion30 Dec 2022 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christophe De Block, Prof., Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04623320
- Sponsor's protocol ID
- 20/40/515
- Acronym
- BRECLAIR
- Status last verified
- Feb 2022
- First submitted
- 4 Nov 2020
- Last updated
- 18 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hussain M, Jangorbhani M, Schuette S, Considine RV, Chisholm RL, Mather KJ. [13C]glucose breath testing provides a noninvasive measure of insulin resistance: calibration analyses against clamp studies. Diabetes Technol Ther. 2014 Feb;16(2):102-12. doi: 10.1089/dia.2013.0151. Epub 2013 Oct 11.
PubMed 24116833Maldonado-Hernandez J, Martinez-Basila A, Salas-Fernandez A, Navarro-Betancourt JR, Pina-Aguero MI, Bernabe-Garcia M. The 13C-Glucose Breath Test for Insulin Resistance Assessment in Adolescents: Comparison with Fasting and Post-Glucose Stimulus Surrogate Markers of Insulin Resistance. J Clin Res Pediatr Endocrinol. 2016 Dec 1;8(4):419-424. doi: 10.4274/jcrpe.3260. Epub 2016 Jun 29.
PubMed 27354200Lewanczuk RZ, Paty BW, Toth EL. Comparison of the [13C]glucose breath test to the hyperinsulinemic-euglycemic clamp when determining insulin resistance. Diabetes Care. 2004 Feb;27(2):441-7. doi: 10.2337/diacare.27.2.441.
PubMed 14747226Mertens J, Roosens L, Braspenning R, Vandebeeck J, Francque S, De Block C. The 13C Glucose Breath Test Accurately Identifies Insulin Resistance in People With Type 1 Diabetes. J Clin Endocrinol Metab. 2025 Jan 21;110(2):e432-e442. doi: 10.1210/clinem/dgae175.
PubMed 38487831Clinck I, Mertens J, Wouters K, Dirinck E, De Block C. Insulin Resistance and CGM-Derived Parameters in People With Type 1 Diabetes: Are They Associated? J Clin Endocrinol Metab. 2024 Oct 15;109(11):e2131-e2140. doi: 10.1210/clinem/dgae015.
PubMed 38198792
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a 13C Glucose Breath Test to Quantify Insulin Resistance in Type 1 Diabetes Mellitus Compared With the Euglycaemic Clamp Test
- ClinicalTrials.gov ID
- NCT04623320
- Acronym / sponsor ID
- BRECLAIR / 20/40/515
- Conditions
- Insulin Resistance, Type 1 Diabetes
- Keywords
- insulin resistance, type 1 diabetes, euglycaemic clamp, breath test
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- 27 Oct 2020 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 10 Nov 2020 (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.
Insulin resistance can be assessed by the euglycaemic clamp technique. To date, this is the golden standard, but it is not suited for clinical practice. A 13C glucose breath test will be tested as a valid alternative. The curve of the exhaled 13C CO2 as a function of glucose metabolism can be correlated to the curve of the glucose disposal rate obtained via the clamp technique.
Detailed description
The hyperinsulinemic-euglycemic clamp technique is the golden standard to assess insulin resistance in type 1 diabetes subjects. The plasma insulin concentration is acutely raised and maintained at 100 μU/ml by a continuous infusion of insulin. Meanwhile, the plasma glucose concentration is held constant at basal levels by a variable glucose infusion. When the steady-state is achieved, the glucose infusion rate equals glucose uptake by all the tissues in the body and is therefore a measure of tissue insulin sensitivity.
These data will be compared with the results of a 13C glucose breath test. Breath tests using 13C substrates are based on the principle that 13C CO2 in the exhaled breath can be measured as a metabolic tracer.
Breath testing has a major advantage over the clamp test in that it can be performed non-invasively and repeatedly without necessary supervision by medical staff.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NAFLD+T1DM+ | – | Diagnostic Test: euglycaemic clamp test, Diagnostic Test: 13C glucose breath testSubjects with type 1 diabetes and ultrasound-defined NAFLD |
| NAFLD-T1DM+ | – | Diagnostic Test: euglycaemic clamp test, Diagnostic Test: 13C glucose breath testSubjects with type 1 diabetes without ultrasound-defined NAFLD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Type 1 diabetes subjects from the research facility's outpatient clinic.
Key inclusion criteria (2 listed)
- Adult type 1 diabetes patients
- 25/50 subjects with confirmed NAFLD (using ultrasound criteria)
Key exclusion criteria (5 listed)
- pregnancy
- gastric bypass surgery
- cirrhosis
- secondary cause of liver steatosis present
- any cause which makes a 4-hour clamp impossible
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 |
|---|---|---|
| euglycaemic clamp testclamp test (golden standard) to determine insulin resistance | Diagnostic test | NAFLD+T1DM+, NAFLD-T1DM+ |
| 13C glucose breath test13C glucose breath test to compare with the golden standard | Diagnostic test | NAFLD+T1DM+, NAFLD-T1DM+ |
Primary outcome
Correlation of the 13C breath test with the golden standard
Time frame: one day
sensitivity and specificity analysis using linear regression
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2022.
- Background: PubMed 24116833Hussain M, Jangorbhani M, Schuette S, Considine RV, Chisholm RL, Mather KJ. [13C]glucose breath testing provides a noninvasive measure of insulin resistance: calibration analyses against clamp studies. Diabetes Technol Ther. 2014 Feb;16(2):102-12. doi: 10.1089/dia.2013.0151. Epub 2013 Oct 11.
- Background: PubMed 27354200Maldonado-Hernandez J, Martinez-Basila A, Salas-Fernandez A, Navarro-Betancourt JR, Pina-Aguero MI, Bernabe-Garcia M. The 13C-Glucose Breath Test for Insulin Resistance Assessment in Adolescents: Comparison with Fasting and Post-Glucose Stimulus Surrogate Markers of Insulin Resistance. J Clin Res Pediatr Endocrinol. 2016 Dec 1;8(4):419-424. doi: 10.4274/jcrpe.3260. Epub 2016 Jun 29.
- Results publication: PubMed 14747226Lewanczuk RZ, Paty BW, Toth EL. Comparison of the [13C]glucose breath test to the hyperinsulinemic-euglycemic clamp when determining insulin resistance. Diabetes Care. 2004 Feb;27(2):441-7. doi: 10.2337/diacare.27.2.441.
- Derived from this study: PubMed 38487831Mertens J, Roosens L, Braspenning R, Vandebeeck J, Francque S, De Block C. The 13C Glucose Breath Test Accurately Identifies Insulin Resistance in People With Type 1 Diabetes. J Clin Endocrinol Metab. 2025 Jan 21;110(2):e432-e442. doi: 10.1210/clinem/dgae175.
- Derived from this study: PubMed 38198792Clinck I, Mertens J, Wouters K, Dirinck E, De Block C. Insulin Resistance and CGM-Derived Parameters in People With Type 1 Diabetes: Are They Associated? J Clin Endocrinol Metab. 2024 Oct 15;109(11):e2131-e2140. doi: 10.1210/clinem/dgae015.
- Individual participant dataSharing planned: No
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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.
Christophe De Block, Prof. principal investigator
University Hospital, Antwerp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Insulin Resistance and Type 1 Diabetes, run by University Hospital, Antwerp at 1 site in Belgium.
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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 18 Mar 2022. 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jonathan Mertens, M.D. (+32 821 74 03, jonathan.mertens@uza.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of the 13C breath test with the golden standard (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04623320, which also lists 5 linked publications.
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 18 Mar 2022.