Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2026-02-26 @ 2:17 AM
Study NCT ID:
NCT00654056
Status:
COMPLETED
Last Update Posted:
2013-03-11
First Post:
2008-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Severe Insulin Resistance in Patients With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], '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': 'D006946', 'term': 'Hyperinsulinism'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007328', 'term': 'Insulin'}], 'ancestors': [{'id': 'D011384', 'term': 'Proinsulin'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-08', 'studyFirstSubmitDate': '2008-03-25', 'studyFirstSubmitQcDate': '2008-04-02', 'lastUpdatePostDateStruct': {'date': '2013-03-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Insulin sensitivity', 'timeFrame': '8 hours'}], 'secondaryOutcomes': [{'measure': 'Changes in insulin signaling proteins?', 'timeFrame': '1 month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Type 2 diabetes', 'Severe insulin resistance'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to investigate some of the mechanisms behind severe insulin resistance and to determine the dose response to insulin in patients with type 2 diabetes mellitus.', 'detailedDescription': 'Overnutrition and obesity are pivotal to the metabolic syndrome and diabetes. The sedentary lifestyle and overly rich nutrition are predominant in Western societies and result in obesity, insulin resistance and type 2 diabetes mellitus. According to the WHO an escalating global epidemic of overweight and obesity is sweeping the globe and the prevalence of type 2 diabetes mellitus rises in parallel at the same alarming rate. It is likely that inherited insulin resistance relates to subtle mutations in many metabolic genes. It is still unclear whether such abnormalities lead to different proteomic patterns in target tissues (muscle and fat) and how intracellular hormone signaling is affected. Some patients with type 2 diabetes mellitus have severe insulin resistance with insulin requirements of more than 100 units/day and are still not optimally controlled. Our aim of this study is to examine the mechanisms behind severe insulin resistance and to elucidate how intracellular hormone signaling is affected, especially in relation to proteomics. Moreover we wish to determine the dose response to insulin in patients with type 2 diabetes mellitus with severe insulin resistance in order to see if there is a measurable effect on blood glucose at high insulin doses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 25-75 years old\n* BMI between 25 and 42\n\nExclusion Criteria:\n\n* Severe diseases'}, 'identificationModule': {'nctId': 'NCT00654056', 'briefTitle': 'Severe Insulin Resistance in Patients With Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Severe Insulin Resistance in Patients With Type 2 Diabetes: Mechanisms Behind Insulin Resistance.', 'orgStudyIdInfo': {'id': 'UKO-M20070267'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'L1', 'description': 'Actrapid infusion, 0.5 mU/kg/min.', 'interventionNames': ['Drug: Actrapid (human insulin)']}, {'type': 'EXPERIMENTAL', 'label': 'L2', 'description': 'Actrapid infusion 1.5 mU/kg/min', 'interventionNames': ['Drug: Actrapid (human insulin)']}, {'type': 'EXPERIMENTAL', 'label': 'H1', 'description': 'Actrapid infusion 3.0 mU/kg/min', 'interventionNames': ['Drug: Actrapid (human insulin)']}, {'type': 'EXPERIMENTAL', 'label': 'H2', 'description': 'Actrapid infusion 5.0 mU/kg/min', 'interventionNames': ['Drug: Actrapid (human insulin)']}], 'interventions': [{'name': 'Actrapid (human insulin)', 'type': 'DRUG', 'description': 'On day one: 0,5 IU/kg/min for 3 hours, 1,5 IU/kg/min for 3 hours, on day two: 3,0 IU/kg/min for 3 hours, 5,0 IU/kg/min for 3 hours', 'armGroupLabels': ['H1', 'H2', 'L1', 'L2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Niels Moeller, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department M (Endocrinology and diabetes), Aarhus University Hospital, Nørrebrogade 44, 8000 Århus C, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aarhus University Hospital', 'class': 'OTHER'}, {'name': 'Regionshospitalet Silkeborg', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}