Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-26 @ 3:29 AM
Study NCT ID:
NCT04623320
Status:
UNKNOWN
Last Update Posted:
2022-03-18
First Post:
2020-11-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Validation of a 13C Glucose Breath Test Compared With the Euglycaemic Clamp Test
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2023-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-03', 'studyFirstSubmitDate': '2020-11-04', 'studyFirstSubmitQcDate': '2020-11-04', 'lastUpdatePostDateStruct': {'date': '2022-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation of the 13C breath test with the golden standard', 'timeFrame': 'one day', 'description': 'sensitivity and specificity analysis using linear regression'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['insulin resistance', 'type 1 diabetes', 'euglycaemic clamp', 'breath test'], 'conditions': ['Insulin Resistance', 'Type 1 Diabetes']}, 'referencesModule': {'references': [{'pmid': '24116833', 'type': 'BACKGROUND', 'citation': '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': '27354200', 'type': 'BACKGROUND', 'citation': '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': '14747226', 'type': 'RESULT', 'citation': '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': '38487831', 'type': 'DERIVED', 'citation': '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': '38198792', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThese 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.\n\nBreath 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Type 1 diabetes subjects from the research facility's outpatient clinic.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult type 1 diabetes patients\n* 25/50 subjects with confirmed NAFLD (using ultrasound criteria)\n\nExclusion Criteria:\n\n* pregnancy\n* gastric bypass surgery\n* cirrhosis\n* secondary cause of liver steatosis present\n* any cause which makes a 4-hour clamp impossible'}, 'identificationModule': {'nctId': 'NCT04623320', 'acronym': 'BRECLAIR', 'briefTitle': 'Validation of a 13C Glucose Breath Test Compared With the Euglycaemic Clamp Test', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Antwerp'}, 'officialTitle': 'Validation of a 13C Glucose Breath Test to Quantify Insulin Resistance in Type 1 Diabetes Mellitus Compared With the Euglycaemic Clamp Test', 'orgStudyIdInfo': {'id': '20/40/515'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'NAFLD+T1DM+', 'description': 'Subjects with type 1 diabetes and ultrasound-defined NAFLD', 'interventionNames': ['Diagnostic Test: euglycaemic clamp test', 'Diagnostic Test: 13C glucose breath test']}, {'label': 'NAFLD-T1DM+', 'description': 'Subjects with type 1 diabetes without ultrasound-defined NAFLD', 'interventionNames': ['Diagnostic Test: euglycaemic clamp test', 'Diagnostic Test: 13C glucose breath test']}], 'interventions': [{'name': 'euglycaemic clamp test', 'type': 'DIAGNOSTIC_TEST', 'description': 'clamp test (golden standard) to determine insulin resistance', 'armGroupLabels': ['NAFLD+T1DM+', 'NAFLD-T1DM+']}, {'name': '13C glucose breath test', 'type': 'DIAGNOSTIC_TEST', 'description': '13C glucose breath test to compare with the golden standard', 'armGroupLabels': ['NAFLD+T1DM+', 'NAFLD-T1DM+']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Antwerp', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Christophe De Block, M.D., PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Antwerp University Hospital', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}], 'centralContacts': [{'name': 'Jonathan Mertens, M.D.', 'role': 'CONTACT', 'email': 'jonathan.mertens@uza.be', 'phone': '+32 821 74 03'}, {'name': 'Maria Braspenning, nurse', 'role': 'CONTACT', 'email': 'Rie.Braspenning@uza.be', 'phone': '+32 821 40 02'}], 'overallOfficials': [{'name': 'Christophe De Block, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Antwerp'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Antwerp', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}