Ignite Creation Date:
2025-12-24 @ 3:44 PM
Ignite Modification Date:
2026-01-05 @ 5:44 PM
Study NCT ID:
NCT05310292
Status:
UNKNOWN
Last Update Posted:
2023-05-12
First Post:
2022-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Glucometabolic Evaluation of Patients With Idiopathic Ketotic Hypoglycemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005951', 'term': 'Glucose Tolerance Test'}, {'id': 'C009907', 'term': '2-methylcyclopentadienyl manganese tricarbonyl'}], 'ancestors': [{'id': 'D001774', 'term': 'Blood Chemical Analysis'}, {'id': 'D019963', 'term': 'Clinical Chemistry Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003940', 'term': 'Diagnostic Techniques, Endocrine'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A case-control intervention study.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2025-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-11', 'studyFirstSubmitDate': '2022-03-25', 'studyFirstSubmitQcDate': '2022-03-25', 'lastUpdatePostDateStruct': {'date': '2023-05-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma glucose', 'timeFrame': '-120, -60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes', 'description': 'The intergroup difference in peak to nadir difference in plasma glucose following OGTT/MMT'}, {'measure': 'Time in range (CGM)', 'timeFrame': '0-14 days of CGM-period', 'description': 'The intergroup difference in time spend in glycemic range, measured by CGM'}], 'secondaryOutcomes': [{'measure': 'Endogenous glucose production', 'timeFrame': '-120,, -60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes', 'description': 'Rate of appearance of glucose, measured by tracer dilution technique'}, {'measure': 'Glucose revomal', 'timeFrame': '-120, -60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes', 'description': 'Rate of disappearance of glucose, measured by tracer dilution technique'}, {'measure': 'Amino acids', 'timeFrame': '-120,-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes', 'description': 'Plasma concentrations of amino acids'}, {'measure': 'Insulin', 'timeFrame': '-120,-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes', 'description': 'Plasma concentrations of insulin'}, {'measure': 'Glucagon', 'timeFrame': '-120,-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes', 'description': 'Plasma concentrations of glucagon'}, {'measure': 'Glucagon like peptide-1 (GLP-1)', 'timeFrame': '-120,-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes', 'description': 'Plasma concentrations of GLP-1'}, {'measure': 'Glucose-dependent insulinotropic polypeptide (GIP)', 'timeFrame': '-120,-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes', 'description': 'Plasma concentrations of GIP'}, {'measure': 'Coefficients of variation (CV) of plasma glucose', 'timeFrame': '0-14 days of CGM-period', 'description': 'CV of plasma glucose measured by CGM'}, {'measure': 'Mean plasma glucose', 'timeFrame': '0-14 days of CGM-period', 'description': 'Average value of plasma glucose measured by CGM'}, {'measure': 'Risk of hypoglycemia', 'timeFrame': '0-14 days of CGM-period', 'description': 'Time spend in hypoglycemia measured by CGM'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Idiopathic ketotic hypoglycemia', 'Glucose metabolism', 'Gut homones', 'Amino acids', 'Glucagon', 'Insulin', 'Continuous glucose monitor', 'CGM', 'Oral glucose tolerance test', 'Mixed meal test'], 'conditions': ['Idiopathic Ketotic Hypoglycemia']}, 'descriptionModule': {'briefSummary': 'The project will evaluate 1) the postprandial metabolism and 2) continuous glucose levels in subjects diagnosed with Idiopathic Ketotic Hypoglycemia (IKH)) and healthy control subjects.', 'detailedDescription': 'IKH is a common, but not fully understood, condition in children, and in some the condition may persist in adulthood. In the present study we seek to evaluate the postprandial metabolism in adult subjects diagnosed with IKH through a clinical study including:\n\n1. two test days, where the subjects completes a) an oral glucose tolerance test (OGTT) and b) a miced meal test (MMT). Before, during and after ingestion of the OGTT/MMT, blood samples will be frequently drawn for the evaluation of plasma glucose, hormones, amino acids and more. During both tests, the subjects will recieve a continuous infusion of primed glucose tracer to further evaluate the glucose metabolism.\n2. a 14-day period where the subjects will lead the usual lives, wearing a continuous glucose monitor (CGM). This will enable us to evaluate long-term differences in plasma glucose levels in IKH.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* IKH-participants:\n* Verified diagnosis of IKH by health professional\n* BMI of 18-30 kg/m2\n* Normal liver- and kidney function\n* informed consent\n\nHealthy control participants\n\n* Normal glucose tolerance\n* BMI of 18-30 kg/m2\n* Normal liver- and kidney function\n* informed consent\n\nExclusion Criteria:\n\n* A history of diabetes\n* close family members with diabetes\n* use of drugs affecting the glucose metabolism that cannot be paused\n* anemia\n* any condition that the study investigators deem unacceptable for participation\n* pregnancy or breastfeeding.'}, 'identificationModule': {'nctId': 'NCT05310292', 'acronym': 'IKH_MetEx', 'briefTitle': 'A Glucometabolic Evaluation of Patients With Idiopathic Ketotic Hypoglycemia', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Gentofte, Copenhagen'}, 'officialTitle': 'A Glucometabolic Evaluation of Patients With Idiopathic Ketotic Hypoglycemia', 'orgStudyIdInfo': {'id': 'H-21056987'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Subjects diagnosed with IKH', 'description': '10 patients, diagnosed with IKH', 'interventionNames': ['Biological: Oral glucose tolerance test', 'Biological: Mixed meal test']}, {'type': 'EXPERIMENTAL', 'label': 'Healthy control subjects', 'description': '10 subjects, healthy, matched for gender, BMI, age', 'interventionNames': ['Biological: Oral glucose tolerance test', 'Biological: Mixed meal test']}], 'interventions': [{'name': 'Oral glucose tolerance test', 'type': 'BIOLOGICAL', 'otherNames': ['OGTT'], 'description': 'Consumption of 75 grams of glucose, diluted in water, added 1,5 g of acetaminophen.', 'armGroupLabels': ['Healthy control subjects', 'Subjects diagnosed with IKH']}, {'name': 'Mixed meal test', 'type': 'BIOLOGICAL', 'otherNames': ['MMT'], 'description': 'Consumption of a standardized liquid meal, with caloric and dietary content equal to a standard meal.', 'armGroupLabels': ['Healthy control subjects', 'Subjects diagnosed with IKH']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2900', 'city': 'Hellerup', 'state': 'Copenhagen', 'country': 'Denmark', 'facility': 'Center for Clinical Metabolic Research, Department of Medicine, Gentofte Hospital', 'geoPoint': {'lat': 55.73204, 'lon': 12.57093}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Gentofte, Copenhagen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Odense University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator, Medical Doctor, PhD student', 'investigatorFullName': 'Magnus Frederik Gluud Grøndahl', 'investigatorAffiliation': 'University Hospital, Gentofte, Copenhagen'}}}}