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

• Conditions: Insulin Resistance; Type 1 Diabetes
• Interventions: Diagnostic Test: euglycaemic clamp test; Diagnostic Test: 13C glucose breath test

• Registration Number: NCT04623320
• Lead Sponsor: University Hospital, Antwerp

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 Timeline

• Study Start: 2020-10-27
• Study First Submitted: 2020-11-04
• Study First Submitted QC: 2020-11-04
• Study First Posted: 2020-11-10
• Status Verified: 2022-02
• Last Update Submitted: 2022-03-03
• Last Update Posted: 2022-03-18
• Primary Completion: 2022-12-30
• Study Completion: 2023-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NAFLD-T1DM+	13C glucose breath test	Subjects with type 1 diabetes without ultrasound-defined NAFLD
NAFLD+T1DM+	13C glucose breath test	Subjects with type 1 diabetes and ultrasound-defined NAFLD
NAFLD-T1DM+	euglycaemic clamp test	Subjects with type 1 diabetes without ultrasound-defined NAFLD
NAFLD+T1DM+	euglycaemic clamp test	Subjects with type 1 diabetes and ultrasound-defined NAFLD

Primary Outcome Measures

Name	Time	Method
Correlation of the 13C breath test with the golden standard	one day	sensitivity and specificity analysis using linear regression

Trial Locations

Locations (1)

Antwerp University Hospital; 🇧🇪 Antwerp, Belgium