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

March 3, 2022 updated by: University Hospital, Antwerp

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Antwerp, Belgium, 2650
        • Recruiting
        • Antwerp University Hospital
        • Principal Investigator:
          • Christophe De Block, M.D., PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Type 1 diabetes subjects from the research facility's outpatient clinic.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
NAFLD+T1DM+
Subjects with type 1 diabetes and ultrasound-defined NAFLD
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
NAFLD-T1DM+
Subjects with type 1 diabetes without ultrasound-defined NAFLD
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of the 13C breath test with the golden standard
Time Frame: one day
sensitivity and specificity analysis using linear regression
one day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Antwerp

Investigators

  • Principal Investigator: Christophe De Block, Prof., University Hospital, Antwerp

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 27, 2020

Primary Completion (Anticipated)

December 30, 2022

Study Completion (Anticipated)

March 31, 2023

Study Registration Dates

First Submitted

November 4, 2020

First Submitted That Met QC Criteria

November 4, 2020

First Posted (Actual)

November 10, 2020

Study Record Updates

Last Update Posted (Actual)

March 18, 2022

Last Update Submitted That Met QC Criteria

March 3, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20/40/515

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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