NCT04623320

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: University Hospital, Antwerp · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Insulin Resistance
• Type 1 Diabetes

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	euglycaemic clamp test	clamp test (golden standard) to determine insulin resistance
DIAGNOSTIC_TEST	13C glucose breath test	13C glucose breath test to compare with the golden standard

Timeline

• Start date: 2020-10-27
• Primary completion: 2022-12-30
• Completion: 2023-03-31
• First posted: 2020-11-10
• Last updated: 2022-03-18

Locations

1 site across 1 country: Belgium