Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-27 @ 11:54 PM
Study NCT ID:
NCT01436734
Status:
COMPLETED
Last Update Posted:
2015-07-14
First Post:
2011-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Aprotinin in Glucagon Degradation, Measurement by Radioimmunoactive Method (RIA) I125
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C512983', 'term': 'Hig1 protein, mouse'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-10', 'studyFirstSubmitDate': '2011-09-08', 'studyFirstSubmitQcDate': '2011-09-19', 'lastUpdatePostDateStruct': {'date': '2015-07-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in plasma glucagon values measured with c-terminal specific "micro-protocol" RIA4305: 350µl of plasma (duplicate sample).', 'timeFrame': '120 min'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Hyperglucagonemia']}, 'descriptionModule': {'briefSummary': "The aim of the study was to investigate the role of the Trasylol in glucagon prevention in degradation using radioimmunoactive method with I125. Additionally different incubation time was introduced in human plasma samples after oral glucose stimulation, also in fasted and hypoglycemia blood samples from patients' type 2 diabetes. Since, the structure and the techniques for the glucagon measurement are well described nowadays."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Caucasians 18 years or older with Type 2 diabetes (WHO criteria)\n\nExclusion Criteria:\n\n* HbA1c \\>9 %\n* Liver disease (ALAT/ASAT \\>2 x upper normal limit)\n* Diabetic nephropathy (s-creatinine \\>130 µM or albuminuria)\n* Proliferative diabetic retinopathy (anamnestic)\n* Severe arteriosclerosis or heart failure (NYHA group III og IV)\n* Anemia\n* treatment with medication not applicable to pause for 12 hours\n* pregnancy or lactation\n* Fasting plasma glucose \\>15 mM on screening day.'}, 'identificationModule': {'nctId': 'NCT01436734', 'briefTitle': 'Role of Aprotinin in Glucagon Degradation, Measurement by Radioimmunoactive Method (RIA) I125', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Gentofte, Copenhagen'}, 'orgStudyIdInfo': {'id': 'H-D-2009-0078'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GIP', 'interventionNames': ['Other: Fasting glycemia', 'Other: Hypoglycemia']}], 'interventions': [{'name': 'Fasting glycemia', 'type': 'OTHER', 'description': 'no intervention', 'armGroupLabels': ['GIP']}, {'name': 'Hypoglycemia', 'type': 'OTHER', 'description': 'Insulin induced hypoglycemia', 'armGroupLabels': ['GIP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2900', 'city': 'Hellerup', 'country': 'Denmark', 'facility': 'Gentofte Hospital', 'geoPoint': {'lat': 55.73204, 'lon': 12.57093}}], 'overallOfficials': [{'name': 'Mikkel Christensen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gentofte Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Gentofte, Copenhagen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Mikkel Christensen', 'investigatorAffiliation': 'University Hospital, Gentofte, Copenhagen'}}}}