Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2025-12-25 @ 10:28 PM
Study NCT ID:
NCT01022658
Status:
COMPLETED
Last Update Posted:
2013-02-21
First Post:
2009-11-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
INSUlin Regimens and VASCular Functions
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': 'D007328', 'term': 'Insulin'}, {'id': 'D000069057', 'term': 'Insulin Detemir'}, {'id': 'D061267', 'term': 'Insulin Aspart'}], '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'}, {'id': 'D049528', 'term': 'Insulin, Long-Acting'}, {'id': 'D061266', 'term': 'Insulin, Short-Acting'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-20', 'studyFirstSubmitDate': '2009-11-30', 'studyFirstSubmitQcDate': '2009-11-30', 'lastUpdatePostDateStruct': {'date': '2013-02-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vago-sympathetic activity, arterial stiffness, endothelial function', 'timeFrame': '4-5 Weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Insulin Therapy', 'Vago-sympathetic activity', 'arterial stiffness', 'endothelial function'], 'conditions': ['Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '17375404', 'type': 'BACKGROUND', 'citation': 'Nitenberg A, Cosson E, Pham I. Postprandial endothelial dysfunction: role of glucose, lipids and insulin. Diabetes Metab. 2006 Sep;32 Spec No2:2S28-33. doi: 10.1016/s1262-3636(06)70482-7.'}, {'pmid': '9614623', 'type': 'BACKGROUND', 'citation': 'Albertini JP, Valensi P, Lormeau B, Aurousseau MH, Ferriere F, Attali JR, Gattegno L. Elevated concentrations of soluble E-selectin and vascular cell adhesion molecule-1 in NIDDM. Effect of intensive insulin treatment. Diabetes Care. 1998 Jun;21(6):1008-13. doi: 10.2337/diacare.21.6.1008.'}, {'pmid': '17375406', 'type': 'BACKGROUND', 'citation': 'Valensi P, Cosson E. Hemodynamic changes in postprandial state. Diabetes Metab. 2006 Sep;32 Spec No2:2S37-41. doi: 10.1016/s1262-3636(06)70484-0.'}, {'pmid': '7735337', 'type': 'BACKGROUND', 'citation': 'Valensi P, Thi BN, Lormeau B, Paries J, Attali JR. Cardiac autonomic function in obese patients. Int J Obes Relat Metab Disord. 1995 Feb;19(2):113-8.'}, {'pmid': '15506059', 'type': 'BACKGROUND', 'citation': 'Dabire H, Brahimi M, Hadj-Brahim F, Le Clesiau H, Attali JR, Valensi P. [Role of vagosympathetic balance in obesity-induced hypertension]. Arch Mal Coeur Vaiss. 2004 Jul-Aug;97(7-8):749-52. French.'}, {'pmid': '12870154', 'type': 'BACKGROUND', 'citation': 'Valensi P, Paries J, Attali JR; French Group for Research and Study of Diabetic Neuropathy. Cardiac autonomic neuropathy in diabetic patients: influence of diabetes duration, obesity, and microangiopathic complications--the French multicenter study. Metabolism. 2003 Jul;52(7):815-20. doi: 10.1016/s0026-0495(03)00095-7.'}, {'pmid': '16154426', 'type': 'BACKGROUND', 'citation': 'Valensi P, Paries J, Lormeau B, Attia S, Attali JR. Influence of nutrients on cardiac autonomic function in nondiabetic overweight subjects. Metabolism. 2005 Oct;54(10):1290-6. doi: 10.1016/j.metabol.2005.04.016.'}, {'pmid': '12208795', 'type': 'BACKGROUND', 'citation': 'Ceriello A, Taboga C, Tonutti L, Quagliaro L, Piconi L, Bais B, Da Ros R, Motz E. Evidence for an independent and cumulative effect of postprandial hypertriglyceridemia and hyperglycemia on endothelial dysfunction and oxidative stress generation: effects of short- and long-term simvastatin treatment. Circulation. 2002 Sep 3;106(10):1211-8. doi: 10.1161/01.cir.0000027569.76671.a8.'}, {'pmid': '9054462', 'type': 'BACKGROUND', 'citation': 'Valensi P, Smagghue O, Paries J, Velayoudon P, Nguyen TN, Attali JR. Peripheral vasoconstrictor responses to sympathetic activation in diabetic patients: relationship with rheological disorders. Metabolism. 1997 Mar;46(3):235-41. doi: 10.1016/s0026-0495(97)90246-8.'}, {'pmid': '10831169', 'type': 'BACKGROUND', 'citation': 'Valensi P, Smagghue O, Paries J, Velayoudon P, Lormeau B, Attali JR. Impairment of skin vasoconstrictive response to sympathetic activation in obese patients: influence of rheological disorders. Metabolism. 2000 May;49(5):600-6. doi: 10.1016/s0026-0495(00)80034-7.'}, {'pmid': '9404427', 'type': 'BACKGROUND', 'citation': 'Sibony-Prat J, Paries J, Chabert M, Attali JR, Valensi P. [Alteration of cardiovascular vagosympathetic control evaluated by spectral analysis of variations of heart rate and blood pressure in obesity]. Arch Mal Coeur Vaiss. 1997 Aug;90(8):1155-8. French.'}, {'pmid': '28954218', 'type': 'DERIVED', 'citation': 'Fysekidis M, Cosson E, Takbou K, Sutton A, Charnaux N, Banu I, Vicaut E, Valensi P. Effects of insulin analogs as an add-on to metformin on cutaneous microcirculation in type 2 diabetic patients. Microvasc Res. 2018 Mar;116:6-14. doi: 10.1016/j.mvr.2017.09.005. Epub 2017 Sep 24.'}]}, 'descriptionModule': {'briefSummary': 'Vago-sympathetic activity, arterial stiffness and endothelial function are integrators of cardiovascular risk. The aim of this pilot study is, in type 2 diabetic patients now requiring insulin, to compare the effects of improving glycemic control on these parameters with 3 different insulin regimens which will act especially at fasting or in post-prandial periods or both. Non invasive explorations will be performed before randomization and after 4 to 5 weeks of insulin therapy, at fasting and each hour after a standardized breakfast.', 'detailedDescription': 'Vago-sympathetic activity, arterial stiffness and endothelial function are integrators of cardiovascular risk. The effect of controlling fasting or post-prandial blood glucose or both on these parameters has not been studied in type 2 diabetic patients.\n\nThe aim of this pilot study is to compare the effects of improving fasting or post-prandial blood glucose glycemic control or both with 3 different insulin regimens for 4 to 5 weeks, on vago-sympathetic activity, arterial stiffness and endothelial function.\n\nPatients will be recruited in the department of Endocrinology-Diabetology-Nutrition of Jean VERDIER hospital, AP-HP, and the department of Endocrinology and Metabolism of AVICENNE hospital, BOBIGNY, AP-HP, France. After an half day of cardiovascular explorations, 42 patients will be randomized in 3 groups determining their treatment for the following 4-5 weeks : insulin therapy with detemir at dinner or bed time, or with aspart at each meal, or with both of them.\n\nInvestigations will be performed in the morning 1) at the time of randomisation and 2) 4-5 weeks after the beginning of insulin therapy. We will evaluate at fasting and each hour after a standardized breakfast biological and metabolic parameters, arterial stiffness, endothelial function and nervous autonomic system with non-invasive devices: Sphygmocor®, Finapres®, laser-doppler et Endopat2000®. Body composition will be evaluated with impedance maestri and BodPod®.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '72 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Consent patient\n* Adults from 30 to 72 years old\n* type 2 diabetic patients for at least 1 year\n* able to self measure capillary blood glucose\n* body mass index 20-37 kg/m²,\n* HbA1c 7.1-12% under Metformin and SULFUNYREAS therapy for at least 2 months\n* anti-hypertensive treatment or dyslipidemic treatment unchanged for 3 months\n\nExclusion criteria:\n\n* pregnancy\n* other antidiabetic medication in the previous 2 months,\n* anti-hypertensive or lipid-lowering therapies having been changed in the previous 2 months,\n* insulin allergy,\n* uncontrolled preproliferative or proliferative diabetic retinopathy\n* uncontrolled hypertension\n* renal failure(creatinin clearance \\<40 ml/min)\n* hepatocellular deficiency (prothrombin time \\<70%)\n* anemia\n* peripheral occlusive arterial disease\n* cardiac arrhythmia'}, 'identificationModule': {'nctId': 'NCT01022658', 'acronym': 'INSUVASC', 'briefTitle': 'INSUlin Regimens and VASCular Functions', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Effects of Different Insulin Regimens on Artery Compliance, Endothelium Function and Autonomic Cardiac Function in Patients With Poorly Controlled Type 2 Diabetes: a Pilot Study', 'orgStudyIdInfo': {'id': 'P090303'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'detemir', 'description': 'Insulin detemir at dinner or bedtime', 'interventionNames': ['Drug: Insulin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'aspart', 'description': 'Insulin aspart before each meal', 'interventionNames': ['Drug: Insulin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'detemir and aspart', 'interventionNames': ['Drug: Insulin']}], 'interventions': [{'name': 'Insulin', 'type': 'DRUG', 'otherNames': ['LEVEMIR', 'NOVORAPID'], 'description': 'For diabetes treatment: metformin continued with insulin (according to arms)', 'armGroupLabels': ['aspart', 'detemir', 'detemir and aspart']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93140', 'city': 'Bondy', 'country': 'France', 'facility': 'Jean Verdier hospital, Department of Endocrinology-Diabetology-Nutrition', 'geoPoint': {'lat': 48.9018, 'lon': 2.48931}}], 'overallOfficials': [{'name': 'Paul Valensi, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Jean VERDIER'}, {'name': 'Emmanuel Cosson, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'CHU-Jean Verdier'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}