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

Type 1 Diabetes Clinical Trial

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

Status Recruiting

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

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

• NCT number: NCT04623320
• Study type: Observational [Patient Registry]
• Source: University Hospital, Antwerp
• Contact: Jonathan Mertens, M.D.
• Phone: +32 821 74 03
• Email: jonathan.mertens@uza.be
• Status: Recruiting
• Start date: October 27, 2020
• Completion date: March 31, 2023