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

Type 1 Diabetes Clinical Trial

— BRECLAIR  

Official title:

Validation of a 13C Glucose Breath Test to Quantify Insulin Resistance in Type 1 Diabetes Mellitus Compared With the Euglycaemic Clamp Test

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04623320
• Other study ID #: 20/40/515
• Status: Recruiting
• Start date: October 27, 2020
• Est. completion date: March 31, 2023

Study information

• Verified date: February 2022
• Source: University Hospital, Antwerp
• Contact: Jonathan Mertens, M.D.
• Phone: +32 821 74 03
• Email: jonathan.mertens[@]uza.be
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 31, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult type 1 diabetes patients

• 25/50 subjects with confirmed NAFLD (using ultrasound criteria)

Exclusion Criteria:

• pregnancy

• gastric bypass surgery

• cirrhosis

• secondary cause of liver steatosis present

• any cause which makes a 4-hour clamp impossible

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Insulin Resistance
• Type 1 Diabetes

Intervention

Diagnostic Test:
• euglycaemic clamp test
clamp test (golden standard) to determine insulin resistance
• 13C glucose breath test
13C glucose breath test to compare with the golden standard

Locations

Country	Name	City	State
Belgium	Antwerp University Hospital	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

References & Publications (3)

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. — View Citation

Lewanczuk 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. — View Citation

Maldonado-Hernández J, Martínez-Basila A, Salas-Fernández A, Navarro-Betancourt JR, Piña-Aguero MI, Bernabe-García 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of the 13C breath test with the golden standard	sensitivity and specificity analysis using linear regression	one day