An observational study in Insulin Resistance and Type 1 Diabetes, sponsored by University Hospital, Antwerp. Status unknown at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-18.
Sponsored by University Hospital, Antwerp · Observational
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.
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.
3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.
This study's planned enrollment of 50 is below the median of 120 across 748 observational studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →University Hospital, Antwerp is the lead sponsor of 234 studies on the registry; 68 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Type 1 diabetes subjects from the research facility's outpatient clinic.
Exclusion Criteria:
Subjects with type 1 diabetes and ultrasound-defined NAFLD
Diagnostic Test: euglycaemic clamp test · Diagnostic Test: 13C glucose breath test
Subjects with type 1 diabetes without ultrasound-defined NAFLD
Diagnostic Test: euglycaemic clamp test · Diagnostic Test: 13C glucose breath test
clamp test (golden standard) to determine insulin resistance
13C glucose breath test to compare with the golden standard
Correlation of the 13C breath test with the golden standard
sensitivity and specificity analysis using linear regression
Time frame: one day
Plan to share: No
This study is status unknown, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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University Hospital, Antwerp