Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-28 @ 12:03 AM
Study NCT ID:
NCT00523393
Status:
UNKNOWN
Last Update Posted:
2009-02-13
First Post:
2007-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Influence of Bedtime Insulin Glargine on Mobilization and Function of Endothelial Progenitor Cells
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069036', 'term': 'Insulin Glargine'}, {'id': 'D007328', 'term': 'Insulin'}], 'ancestors': [{'id': 'D049528', 'term': 'Insulin, Long-Acting'}, {'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'}, {'id': 'D011384', 'term': 'Proinsulin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2010-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-02-12', 'studyFirstSubmitDate': '2007-08-29', 'studyFirstSubmitQcDate': '2007-08-29', 'lastUpdatePostDateStruct': {'date': '2009-02-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-08-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of number of circulating EPC 4 weeks after start of therapy compared to baseline as detected by FACS analysis', 'timeFrame': '4 weaks of treatment'}], 'secondaryOutcomes': [{'measure': 'Change of number of circulating EPC 4 as detected by in vitro outgrowth', 'timeFrame': '4 weeks, 4 months'}, {'measure': 'Skin microvascular function (as measured by laser Doppler perfusion upon heat stimulation)', 'timeFrame': '4 months'}, {'measure': 'Myocardial function and myocardial perfusion reserve as measured by MRI', 'timeFrame': '4 months'}, {'measure': 'Intima-Media-Thickness', 'timeFrame': '4 months'}, {'measure': 'Long-term Glucose control (HbA1c)', 'timeFrame': '4 weeks, 4 months'}, {'measure': 'Short-term Glucose control (fasting glucose)', 'timeFrame': '4 weeks, 4 months'}, {'measure': 'Markers of inflammation and vascular risk in diabetes', 'timeFrame': '4 weeks, 4 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '25300286', 'type': 'DERIVED', 'citation': 'Oikonomou D, Kopf S, von Bauer R, Djuric Z, Cebola R, Sander A, Englert S, Vittas S, Hidmark A, Morcos M, Korosoglou G, Nawroth PP, Humpert PM. Influence of insulin and glargine on outgrowth and number of circulating endothelial progenitor cells in type 2 diabetes patients: a partially double-blind, randomized, three-arm unicenter study. Cardiovasc Diabetol. 2014 Oct 11;13:137. doi: 10.1186/s12933-014-0137-4.'}]}, 'descriptionModule': {'briefSummary': 'In this trial, it will be studied whether early addition of the long acting insulin analogue Glargine is capable of increasing the number and differentiation of endothelial progenitor cells (EPC) in patients with type 2 diabetes, which can be seen as a marker of vascular regenerative potential and cardiovascular risk. In addition, the effect of Glargine on microvascular function will be studied. This will be done using laser Doppler measurements of the skin; in addition, MRI of the heart will be performed which is capable of quantifying the perfusion reserve of the myocardium and additional functional aspects of ventricular function. A beneficial effect of early addition of bedtime Glargine on EPC and vascular as well as myocardial function in this study might argue for a change in the therapeutic approach in type 2 diabetes and possibly improve the cardiovascular outcome in patients affected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 Diabetes\n* Oral antidiabetic therapy\n* Age 35 - 70\n* 6,5%\\< HbA1c ≤ 9%\n* Ability of subject to understand character and individual consequences of clinical trial\n* Written informed consent must be available before enrollment in the trial\n* For women with childbearing potential, adequate contraception (Pearl Index \\< 1%, e.g. birth control pill) and negative blood pregnancy test\n* 6,5%\\< HbA1c ≤ 9%\n* Ability of subject to understand character and individual consequences of clinical trial\n* Written informed consent must be available before enrollment in the trial\n* For women with childbearing potential, adequate contraception (Pearl Index \\< 1%, e.g. birth control pill) and negative blood pregnancy test\n\nExclusion Criteria:\n\n* MODY\n* Malignant disease\n* Hematopoietic disorders\n* Impairment of renal function (Serum creatinine \\> 1,5mg/dl)\n* autoimmune disease\n* treatment with immunosuppressive drugs\n* Psychiatric disease\n* Myocardial ischemia during previous 6 month\n* Acute coronary syndrome\n* pAVK IIb, III, IV (Fontaine-Ratschow)\n* Erythropoietin treatment\n* Glitazone treatment during two weeks before inclusion\n* Insulin treatment during two weeks before inclusion\n* Pregnancy and lactation\n* History of hypersensitivity to the investigational product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational product\n* Participation in other clinical trials and observation period of competing trials, respectively\n* No subject will be allowed to enroll in this trial more than once.'}, 'identificationModule': {'nctId': 'NCT00523393', 'briefTitle': 'Prospective Influence of Bedtime Insulin Glargine on Mobilization and Function of Endothelial Progenitor Cells', 'organization': {'class': 'OTHER', 'fullName': 'Heidelberg University'}, 'officialTitle': 'Prospective Influence of Bedtime Insulin Glargine on Mobilization and Function of Endothelial Progenitor Cells in Patients With Type 2 Diabetes: a Partially Double-Blind, Randomized, Three-Arm Unicenter Study', 'orgStudyIdInfo': {'id': '2006-006573-24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': '1'}, {'type': 'EXPERIMENTAL', 'label': '2', 'interventionNames': ['Drug: Insulin Glargin']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'interventionNames': ['Drug: Human Insulin']}], 'interventions': [{'name': 'Insulin Glargin', 'type': 'DRUG', 'otherNames': ['Lantus®, HOE901 (internal code number Sanofi-Aventis)'], 'description': 'Titration of bedtime insulin glargin aiming at normal morning fasting glucose', 'armGroupLabels': ['2']}, {'name': 'Human Insulin', 'type': 'DRUG', 'otherNames': ['Insuman Basal®, HR1799(internal code number Sanofi-Aventis)'], 'description': 'Titration of bedtime human insulin aiming at normal morning fasting glucose', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69120', 'city': 'Heidelberg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Dimitrios Oikonomou', 'role': 'CONTACT', 'email': 'dimitrios.oikonomou@med.uni-heidelberg.de', 'phone': '+49 6221 56', 'phoneExt': '37944'}], 'facility': 'University Clinics Heidelberg, Dept. Medicine1', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}], 'centralContacts': [{'name': 'Per M Humpert, Dr.', 'role': 'CONTACT', 'email': 'per.humpert@med.uni-heidelberg.de', 'phone': '+49 6221 56', 'phoneExt': '8027'}, {'name': 'Dimitrios Oikonomou', 'role': 'CONTACT', 'email': 'dimitrios.oikonomou@med.uni-heidelberg.de', 'phone': '+49 6221 56', 'phoneExt': '37944'}], 'overallOfficials': [{'name': 'Per M Humpert, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Heidelberg, Dept. Medicine 1, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heidelberg University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr. Per M. Humpert', 'oldOrganization': 'University of Heidelberg'}}}}