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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 27, 2020

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

November 4, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 10, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

March 18, 2022

Status Verified

February 1, 2022

Enrollment Period

2.2 years

First QC Date

November 4, 2020

Last Update Submit

March 3, 2022

Conditions

Insulin ResistanceType 1 Diabetes

Keywords

insulin resistancetype 1 diabeteseuglycaemic clampbreath test

Outcome Measures

Primary Outcomes (1)

  • Correlation of the 13C breath test with the golden standard

    sensitivity and specificity analysis using linear regression

    one day

Study Arms (2)

NAFLD+T1DM+

Subjects with type 1 diabetes and ultrasound-defined NAFLD

Diagnostic Test: euglycaemic clamp testDiagnostic Test: 13C glucose breath test

NAFLD-T1DM+

Subjects with type 1 diabetes without ultrasound-defined NAFLD

Diagnostic Test: euglycaemic clamp testDiagnostic Test: 13C glucose breath test

Interventions

euglycaemic clamp testDIAGNOSTIC_TEST

clamp test (golden standard) to determine insulin resistance

NAFLD+T1DM+NAFLD-T1DM+
13C glucose breath testDIAGNOSTIC_TEST

13C glucose breath test to compare with the golden standard

NAFLD+T1DM+NAFLD-T1DM+

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Adult type 1 diabetes patients
  • /50 subjects with confirmed NAFLD (using ultrasound criteria)

You may not qualify if:

  • pregnancy
  • gastric bypass surgery
  • cirrhosis
  • secondary cause of liver steatosis present
  • any cause which makes a 4-hour clamp impossible

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antwerp University Hospital

Antwerp, 2650, Belgium

RECRUITING

Related Publications (5)

  • Hussain M, Jangorbhani M, Schuette S, Considine RV, Chisholm RL, Mather KJ. [13C]glucose breath testing provides a noninvasive measure of insulin resistance: calibration analyses against clamp studies. Diabetes Technol Ther. 2014 Feb;16(2):102-12. doi: 10.1089/dia.2013.0151. Epub 2013 Oct 11.

    PMID: 24116833BACKGROUND

  • Maldonado-Hernandez J, Martinez-Basila A, Salas-Fernandez A, Navarro-Betancourt JR, Pina-Aguero MI, Bernabe-Garcia M. The 13C-Glucose Breath Test for Insulin Resistance Assessment in Adolescents: Comparison with Fasting and Post-Glucose Stimulus Surrogate Markers of Insulin Resistance. J Clin Res Pediatr Endocrinol. 2016 Dec 1;8(4):419-424. doi: 10.4274/jcrpe.3260. Epub 2016 Jun 29.

    PMID: 27354200BACKGROUND

  • Lewanczuk RZ, Paty BW, Toth EL. Comparison of the [13C]glucose breath test to the hyperinsulinemic-euglycemic clamp when determining insulin resistance. Diabetes Care. 2004 Feb;27(2):441-7. doi: 10.2337/diacare.27.2.441.

    PMID: 14747226RESULT

  • Mertens J, Roosens L, Braspenning R, Vandebeeck J, Francque S, De Block C. The 13C Glucose Breath Test Accurately Identifies Insulin Resistance in People With Type 1 Diabetes. J Clin Endocrinol Metab. 2025 Jan 21;110(2):e432-e442. doi: 10.1210/clinem/dgae175.

    PMID: 38487831DERIVED

  • Clinck I, Mertens J, Wouters K, Dirinck E, De Block C. Insulin Resistance and CGM-Derived Parameters in People With Type 1 Diabetes: Are They Associated? J Clin Endocrinol Metab. 2024 Oct 15;109(11):e2131-e2140. doi: 10.1210/clinem/dgae015.

    PMID: 38198792DERIVED

MeSH Terms

Conditions

Insulin ResistanceDiabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDiabetes MellitusEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Christophe De Block, Prof.

    University Hospital, Antwerp

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan Mertens, M.D.

CONTACT

+32 821 74 03jonathan.mertens@uza.be

Maria Braspenning, nurse

CONTACT

+32 821 40 02Rie.Braspenning@uza.be

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2020

First Posted

November 10, 2020

Study Start

October 27, 2020

Primary Completion

December 30, 2022

Study Completion

March 31, 2023

Last Updated

March 18, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)