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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04623320
Acronym
BRECLAIR
Enrollment
50
Registered
2020-11-10
Start date
2020-10-27
Completion date
2023-03-31
Last updated
2022-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insulin Resistance, Type 1 Diabetes

Keywords

insulin resistance, type 1 diabetes, euglycaemic clamp, breath test

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.

Interventions

DIAGNOSTIC_TESTeuglycaemic clamp test

clamp test (golden standard) to determine insulin resistance

DIAGNOSTIC_TEST13C glucose breath test

13C glucose breath test to compare with the golden standard

Sponsors

University Hospital, Antwerp
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Correlation of the 13C breath test with the golden standardone daysensitivity and specificity analysis using linear regression

Countries

Belgium

Contacts

Primary ContactJonathan Mertens, M.D.
jonathan.mertens@uza.be+32 821 74 03
Backup ContactMaria Braspenning, nurse
Rie.Braspenning@uza.be+32 821 40 02

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026