Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-27 @ 11:42 PM
Study NCT ID:
NCT01053234
Status:
COMPLETED
Last Update Posted:
2022-10-19
First Post:
2010-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Different Insulin Regimens and Postprandial Coagulation Activation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D006943', 'term': 'Hyperglycemia'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-18', 'studyFirstSubmitDate': '2010-01-20', 'studyFirstSubmitQcDate': '2010-01-20', 'lastUpdatePostDateStruct': {'date': '2022-10-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-01-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prothrombin fragment 1+2', 'timeFrame': '7.40; 9.30; 11.30; 13.30; 15.30'}], 'secondaryOutcomes': [{'measure': 'C-reactive protein', 'timeFrame': '7.40; 9.30; 11.30; 13.30; 15.30'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hyperglycaemia', 'Postprandial', 'Type 2 diabetes', 'Cardiovascular risk markers'], 'conditions': ['Type 2 Diabetes', 'Cardiovascular Risk', 'Hemostasis', 'Inflammation', 'Endothelial Function']}, 'descriptionModule': {'briefSummary': 'The purpose of this study in patients with type 2 diabetes was to investigate the acute effect of postprandial blood glucose levels modified by two different insulin treatment regimens on coagulation activation, inflammation and endothelial cell function. The investigators hypothesized that the rapid-acting insulin analogue aspart has a beneficial postprandial effect on coagulation, endothelial dysfunction and inflammation compared with the intermediate-acting insulin NPH due to its ability to lower postprandial glycaemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 30-75 years\n* BMI \\> 25 kg/m2\n* type 2 diabetes for more than 4 years\n* pharmacological anti-diabetic treatment with insulin NPH at bedtime or insulin aspart at meals for more than 24 months\n* metformin with stable dose \\>1000 mg/d for more than 12 weeks\n* acetylsalicylic acid (75 mg/d) for more than 2 weeks\n* no other anti-diabetic treatment 3 month previously\n* HbA1c\\<8.5% at recruitment.\n\nExclusion Criteria:\n\n* creatinine \\> 120 µmol/l\n* ALAT /ASAT \\> 2.5 x upper reference limit\n* use of anticoagulants within 1 month previously\n* any changes in dose of statins within 1 month previously\n* night work\n* present or planned pregnancy\n* mental sickness or alcohol abuse\n* clinically relevant major organ or systemic illness\n* uncontrolled hypertension \\>180/110 mmHg\n* steroid treatment\n* known or suspected allergy to trial medications.'}, 'identificationModule': {'nctId': 'NCT01053234', 'briefTitle': 'Different Insulin Regimens and Postprandial Coagulation Activation', 'organization': {'class': 'OTHER', 'fullName': 'Esbjerg Hospital - University Hospital of Southern Denmark'}, 'officialTitle': 'Effects of Standardised Meals on Postprandial Coagulation Activation in Patients With Type 2 Diabetes Treated With Two Different Insulin Regimens', 'orgStudyIdInfo': {'id': 'RRS 2006-1032'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Insulin aspart', 'interventionNames': ['Dietary Supplement: Standardised meals']}, {'type': 'EXPERIMENTAL', 'label': 'NPH insulin', 'interventionNames': ['Dietary Supplement: Standardised meals']}], 'interventions': [{'name': 'Standardised meals', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Insulin aspart', 'NPH insulin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6700', 'city': 'Esbjerg', 'country': 'Denmark', 'facility': 'Hospital of South West Denmark', 'geoPoint': {'lat': 55.47028, 'lon': 8.45187}}], 'overallOfficials': [{'name': 'Jeppe Gram, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Medicine, Hospital of South West Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Esbjerg Hospital - University Hospital of Southern Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ribe County Hospital', 'class': 'OTHER'}, {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Chief physician, Ph.D Jeppe Gram', 'oldOrganization': 'Department of Medicine, Hospital of South West Denmark'}}}}