Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-25 @ 4:26 AM
NCT ID:
NCT04623320
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.
Study:
NCT04623320
Study Brief:
Protocol Section:
NCT04623320