Clinical trial NCT04623320: Validation of a 13C Glucose Breath Test Compared With the Euglycaemic Clamp Test
Official title: Validation of a 13C Glucose Breath Test to Quantify Insulin Resistance in Type 1 Diabetes Mellitus Compared With the Euglycaemic Clamp Test
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Insulin Resistance
Type 1 Diabetes
Keywords: insulin resistance
type 1 diabetes
euglycaemic clamp
breath test
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2020-11-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Type 1 diabetes subjects from the research facility's outpatient clinic.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Correlation of the 13C breath test with the golden standard
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: Antwerp University Hospital
Study officials:
affiliation: University Hospital, Antwerp
name: Christophe De Block, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Maldonado-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.
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. doi: 10.2337/diacare.27.2.441.