Nctid:
NCT06611904
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000000419", "term"=>"Albuminuria"}, {"id"=>"D000003924", "term"=>"Diabetes Mellitus, Type 2"}], "ancestors"=>[{"id"=>"D000003920", "term"=>"Diabetes Mellitus"}, {"id"=>"D000044882", "term"=>"Glucose Metabolism Disorders"}, {"id"=>"D000008659", "term"=>"Metabolic Diseases"}, {"id"=>"D000004700", "term"=>"Endocrine System Diseases"}, {"id"=>"D000011507", "term"=>"Proteinuria"}, {"id"=>"D000014555", "term"=>"Urination Disorders"}, {"id"=>"D000014570", "term"=>"Urologic Diseases"}, {"id"=>"D000052776", "term"=>"Female Urogenital Diseases"}, {"id"=>"D000005261", "term"=>"Female Urogenital Diseases and Pregnancy Complications"}, {"id"=>"D000091642", "term"=>"Urogenital Diseases"}, {"id"=>"D000052801", "term"=>"Male Urogenital Diseases"}, {"id"=>"D000020924", "term"=>"Urological Manifestations"}], "browseLeaves"=>[{"id"=>"M7119", "name"=>"Diabetes Mellitus, Type 2", "asFound"=>"Type 2 Diabetes", "relevance"=>"HIGH"}, {"id"=>"M7115", "name"=>"Diabetes Mellitus", "relevance"=>"LOW"}, {"id"=>"M3766", "name"=>"Albuminuria", "asFound"=>"Albuminuria", "relevance"=>"HIGH"}, {"id"=>"M11639", "name"=>"Metabolic Diseases", "relevance"=>"LOW"}, {"id"=>"M25403", "name"=>"Glucose Metabolism Disorders", "relevance"=>"LOW"}, {"id"=>"M7862", "name"=>"Endocrine System Diseases", "relevance"=>"LOW"}, {"id"=>"M14368", "name"=>"Proteinuria", "relevance"=>"LOW"}, {"id"=>"M17305", "name"=>"Urination Disorders", "relevance"=>"LOW"}, {"id"=>"M17319", "name"=>"Urologic Diseases", "relevance"=>"LOW"}, {"id"=>"M2875", "name"=>"Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M27093", "name"=>"Female Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M14127", "name"=>"Pregnancy Complications", "relevance"=>"LOW"}, {"id"=>"M8399", "name"=>"Female Urogenital Diseases and Pregnancy Complications", "relevance"=>"LOW"}, {"id"=>"M27095", "name"=>"Male Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M22659", "name"=>"Urological Manifestations", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Nutritional and Metabolic Diseases", "abbrev"=>"BC18"}, {"name"=>"Gland and Hormone Related Diseases", "abbrev"=>"BC19"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"C000555680", "term"=>"Dulaglutide"}, {"id"=>"D000054873", "term"=>"Dipeptidyl-Peptidase IV Inhibitors"}], "ancestors"=>[{"id"=>"D000097789", "term"=>"Glucagon-Like Peptide-1 Receptor Agonists"}, {"id"=>"D000007004", "term"=>"Hypoglycemic Agents"}, {"id"=>"D000045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D000011480", "term"=>"Protease Inhibitors"}, {"id"=>"D000004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D000045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}], "browseLeaves"=>[{"id"=>"M348449", "name"=>"Dapagliflozin", "relevance"=>"LOW"}, {"id"=>"M11667", "name"=>"Metformin", "relevance"=>"LOW"}, {"id"=>"M258626", "name"=>"Dulaglutide", "asFound"=>"Glutamine", "relevance"=>"HIGH"}, {"id"=>"M27957", "name"=>"Dipeptidyl-Peptidase IV Inhibitors", "asFound"=>"Meta-", "relevance"=>"HIGH"}, {"id"=>"M26997", "name"=>"Glucagon-Like Peptide 1", "relevance"=>"LOW"}, {"id"=>"M9043", "name"=>"Glucagon", "relevance"=>"LOW"}, {"id"=>"M3401", "name"=>"Glucagon-Like Peptide-1 Receptor Agonists", "relevance"=>"LOW"}, {"id"=>"M10054", "name"=>"Hypoglycemic Agents", "relevance"=>"LOW"}, {"id"=>"M19609", "name"=>"HIV Protease Inhibitors", "relevance"=>"LOW"}, {"id"=>"M14343", "name"=>"Protease Inhibitors", "relevance"=>"LOW"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Hypoglycemic Agents", "abbrev"=>"Hypo"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Gastrointestinal Agents", "abbrev"=>"Gast"}, {"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"PREVENTION", "interventionModel"=>"SINGLE_GROUP"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>60}}, "statusModule"=>{"overallStatus"=>"ACTIVE_NOT_RECRUITING", "startDateStruct"=>{"date"=>"2018-02-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2024-12-15", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-22", "studyFirstSubmitDate"=>"2024-09-20", "studyFirstSubmitQcDate"=>"2024-09-22", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2022-02-05", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"UACR", "timeFrame"=>"4 and 12 months", "description"=>"UACR change after 4 and 12 months of treatment"}, {"measure"=>"PWV", "timeFrame"=>"4 and 12 months", "description"=>"PWV change after 4 and 12 months of treatment"}, {"measure"=>"PBR", "timeFrame"=>"4 and 12 months", "description"=>"PBR change after 4 and 12 months of treatment"}, {"measure"=>"GLS", "timeFrame"=>"4 and 12 months", "description"=>"GLS change after 4 and 12 months of ttreatment"}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["type 2 diabetes", "albuminuria", "arterial stiffness", "glycocalyx"], "conditions"=>["Urine Albumin (UAlb)", "Glycocalyx", "Arterial Stiffness"]}, "referencesModule"=>{"references"=>[{"pmid"=>"31284526", "type"=>"RESULT", "citation"=>"Lambadiari V, Pavlidis G, Kousathana F, Maratou E, Georgiou D, Andreadou I, Kountouri A, Varoudi M, Balampanis K, Parissis J, Triantafyllidi H, Katogiannis K, Birba D, Lekakis J, Dimitriadis G, Ikonomidis I. Effects of Different Antidiabetic Medications on Endothelial Glycocalyx, Myocardial Function, and Vascular Function in Type 2 Diabetic Patients: One Year Follow-Up Study. J Clin Med. 2019 Jul 5;8(7):983. doi: 10.3390/jcm8070983."}, {"pmid"=>"29310645", "type"=>"RESULT", "citation"=>"Lambadiari V, Pavlidis G, Kousathana F, Varoudi M, Vlastos D, Maratou E, Georgiou D, Andreadou I, Parissis J, Triantafyllidi H, Lekakis J, Iliodromitis E, Dimitriadis G, Ikonomidis I. Effects of 6-month treatment with the glucagon like peptide-1 analogue liraglutide on arterial stiffness, left ventricular myocardial deformation and oxidative stress in subjects with newly diagnosed type 2 diabetes. Cardiovasc Diabetol. 2018 Jan 8;17(1):8. doi: 10.1186/s12933-017-0646-z."}]}, "descriptionModule"=>{"briefSummary"=>"Patients with Type 2 Diabetes Mellitus and albuminuria will be randomised eitheer to dulaglutide and dapagliflozin combination or DPP-4 inhibitor, as an add-on treatment to metformin. Arterial stiffness, UACR, endothelial glycocalyx and global longitudinal strain will be assesed at baseline, 4 and 12 months.", "detailedDescription"=>"Patients with Type 2 Diabetes Mellitus and albuminuria will be randomised eitheer to dulaglutide and dapagliflozin combination or DPP-4 inhibitor, as an add-on treatment to metformin. Arterial stiffness via pulse wave velocity (PWV), UACR, endothelial glycocalyx via Microscan camera, and global longitudinal strain via echocardiography will be assesed at baseline, 4 and 12 months after treatment."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"80 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Type 2 diabetes mellitus Albuminuria HbA1c: 7-10% eGFR\\> 60 ml/min\n\nExclusion Criteria:\n\n* Type 1 diabetes mellitus Inflammation, chronic or acute Established cardiovascular disease Malignancy within the last 5 years"}, "identificationModule"=>{"nctId"=>"NCT06611904", "briefTitle"=>"The Effect of Combined Dulaglutide and Dapagliflozin Treatment vs DPP-4 Inhibitors in Endothelial and Vascular Function in Patients With Type 2 Diabetes Mellitus and Albuminuria", "organization"=>{"class"=>"OTHER", "fullName"=>"Attikon Hospital"}, "officialTitle"=>"Study of Endothelial Glycocalyx and Vascular Function in Patients With Type 2 Diabetes and Albuminuria After Administration of Dulaglutide and Dapagliflozin vs DPP-4 Inhibitors", "orgStudyIdInfo"=>{"id"=>"456/11-06-2017"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"ACTIVE_COMPARATOR", "label"=>"Patients receiving dulaglutide and dapagliflozin", "description"=>"Patients with T2DM and albuminuria receiving dulaglutide and dapagliflozin", "interventionNames"=>["Drug: Dulaglutide"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"Patients receiving DPP-4i", "description"=>"Patients with T2DM and albuminuria receiving DPP-4i", "interventionNames"=>["Drug: DPP-4 Inhibitors"]}], "interventions"=>[{"name"=>"Dulaglutide", "type"=>"DRUG", "description"=>"Combined treatment with dulaglutide and dapagliflozin", "armGroupLabels"=>["Patients receiving dulaglutide and dapagliflozin"]}, {"name"=>"DPP-4 Inhibitors", "type"=>"DRUG", "description"=>"DPP-4i treatment as an add-on to metformin", "armGroupLabels"=>["Patients receiving DPP-4i"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"12462", "city"=>"Chaidari", "state"=>"Attica", "country"=>"Greece", "facility"=>"Attikon University General Hospital", "geoPoint"=>{"lat"=>38.01135, "lon"=>23.66597}}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"UNDECIDED"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Attikon Hospital", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Professor of Internal Medicine and Endocrinology", "investigatorFullName"=>"VAIA LAMBADIARI", "investigatorAffiliation"=>"Attikon Hospital"}}}}
