{ "FullStudy":{ "Rank":217737, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01517490", "OrgStudyIdInfo":{ "OrgStudyId":"Klefter1" }, "Organization":{ "OrgFullName":"Glostrup University Hospital, Copenhagen", "OrgClass":"OTHER" }, "BriefTitle":"Retinal Adaptation to Intensified Insulin Therapy and Bariatric Surgery in Patients With Diabetes", "OfficialTitle":"Retinal Adaptation to Intensified Insulin Therapy and Bariatric Surgery in Patients With Diabetes" }, "StatusModule":{ "StatusVerifiedDate":"March 2015", "OverallStatus":"Unknown status", "LastKnownStatus":"Recruiting", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"August 2011" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"December 2016", "PrimaryCompletionDateType":"Anticipated" }, "StudyFirstSubmitDate":"January 23, 2012", "StudyFirstSubmitQCDate":"January 24, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 25, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"March 10, 2015", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"March 11, 2015", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Principal Investigator", "ResponsiblePartyInvestigatorFullName":"Oliver Niels Klefter", "ResponsiblePartyInvestigatorTitle":"Principal Investigator", "ResponsiblePartyInvestigatorAffiliation":"Glostrup University Hospital, Copenhagen" }, "LeadSponsor":{ "LeadSponsorName":"Glostrup University Hospital, Copenhagen", "LeadSponsorClass":"OTHER" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"Retinal function is highly dependent on the glucose supply. Thus, functional adaptations occur in response to both acute and long-term changes in glycaemia.\n\nThe purpose of this study is to examine functional and metabolic aspects of retinal adaptation to long-lasting changes in glycaemic control in patients with diabetes. The adaptational phenomena will be characterized by electroretinography, dark adaptation, measures of retinal perfusion and oximetry as well as diabetic retinopathy grading and (OCT)." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Diabetes Mellitus", "Diabetic Retinopathy" ] } }, "DesignModule":{ "StudyType":"Observational", "DesignInfo":{ "DesignTimePerspectiveList":{ "DesignTimePerspective":[ "Prospective" ] } }, "EnrollmentInfo":{ "EnrollmentCount":"100", "EnrollmentType":"Anticipated" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Type 1 Insulin Pump", "ArmGroupDescription":"Patients with type 1 diabetes starting insulin pump treatment", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Other: Insulin pump" ] } },{ "ArmGroupLabel":"Type 1 conventional therapy", "ArmGroupDescription":"Patients with type 1 diabetes continuing treatment with multiple daily insulin injections.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Other: Multiple daily insulin injections" ] } },{ "ArmGroupLabel":"Type 2 Bariatric surgery", "ArmGroupDescription":"Patients with type 2 diabetes who are enrolled in pre-operative weight loss protocol prior to bariatric surgery.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Procedure: Bariatric surgery" ] } },{ "ArmGroupLabel":"Type 2 conventional", "ArmGroupDescription":"Severely obese patients with type 2 diabetes who are to continue with non-surgical treatments of diabetes and obesity and with no planned bariatric surgery.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Other: Medical therapy for type 2 diabetes" ] } },{ "ArmGroupLabel":"Type 1 insulin pumpe follow-up", "ArmGroupDescription":"Patients with type 1 diabetes previously followed in an observational study with electrophysiological and psychophysical measures of retinal function.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Other: Insulin pump" ] } },{ "ArmGroupLabel":"Healthy", "ArmGroupDescription":"Healthy volunteers." } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Other", "InterventionName":"Insulin pump", "InterventionDescription":"Insulin pump therapy", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Type 1 Insulin Pump", "Type 1 insulin pumpe follow-up" ] } },{ "InterventionType":"Other", "InterventionName":"Multiple daily insulin injections", "InterventionDescription":"Multiple daily insulin injections", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Type 1 conventional therapy" ] } },{ "InterventionType":"Procedure", "InterventionName":"Bariatric surgery", "InterventionDescription":"Pre-operative weight loss and bariatric surgery.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Type 2 Bariatric surgery" ] } },{ "InterventionType":"Other", "InterventionName":"Medical therapy for type 2 diabetes", "InterventionDescription":"Medical glucose-lowering therapy and non-surgical weight-lowering interventions.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Type 2 conventional" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Changes in dark adaptation kinetics and threshold values, amplitudes/implicit times, retinal vessel diameters, perfusion velocity and oximetry.", "PrimaryOutcomeTimeFrame":"Baseline, 1 week, 1 month, 4 months, 7 months, 12 months, 18 months, 24 months, 42 months" },{ "PrimaryOutcomeMeasure":"Changes in visual acuity, diabetic retinopathy grading and OCT", "PrimaryOutcomeTimeFrame":"Baseline, 1 week, 1 month, 4 months, 7 months, 12 months, 18 months, 24 months, 42 months" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nPatients with type 1 diabetes and suboptimal metabolic regulation.\nPatients with type 2 diabetes and suboptimal metabolic regulation.\n\nExclusion Criteria:\n\nSignificant cataract\nGlaucoma\nProliferative diabetic retinopathy fulfilling ETDRS treatment criteria.\nClinically significant macular edema fulfilling ETDRS treatment criteria.\nAge-related macular degeneration\nPrior surgery to the eye\nOther serious eye disease\nHypertension", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] }, "StudyPopulation":"30 patients with type 1 diabetes and suboptimal metabolic regulation which is to be optimized by insulin pump therapy.\n\n30 patients with type 1 diabetes and suboptimal metabolic regulation in whom insulin pump therapy is not planned.\n\n20 patients with type 2 diabetes and suboptimal metabolic regulation who are enrolled in a pre-operative weight lowering protocol prior to bariatric surgery.\n\n20 patients with type 2 diabetes and suboptimal metabolic regulation who are not enrolled in treatment protocols relating to bariatric surgery.\n\n17 patients with type 1 diabetes on insulin pump therapy who were previously followed in an observational study of retinal function.", "SamplingMethod":"Non-Probability Sample" }, "ContactsLocationsModule":{ "CentralContactList":{ "CentralContact":[ { "CentralContactName":"Oliver Klefter, MD", "CentralContactRole":"Contact", "CentralContactPhone":"+45 38 63 48 18" } ] }, "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Oliver Klefter, MD", "OverallOfficialAffiliation":"Glostrup UH", "OverallOfficialRole":"Principal Investigator" },{ "OverallOfficialName":"Michael Larsen, Professor, DMSci", "OverallOfficialAffiliation":"Glostrup UH", "OverallOfficialRole":"Study Director" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Department of Ophthalmology, Glostrup Hospital", "LocationStatus":"Recruiting", "LocationCity":"Glostrup", "LocationZip":"2600", "LocationCountry":"Denmark", "LocationContactList":{ "LocationContact":[ { "LocationContactName":"Oliver Klefter, MD", "LocationContactRole":"Contact", "LocationContactPhone":"+45 38 63 48 18", "LocationContactEMail":"oliver.niels@gmail.com" },{ "LocationContactName":"Michael Larsen, Professor, DMSci", "LocationContactRole":"Contact", "LocationContactPhone":"+45 38 63 48 34" },{ "LocationContactName":"Oliver Klefter, MD", "LocationContactRole":"Principal Investigator" },{ "LocationContactName":"Michael Larsen, Professor, DMSci", "LocationContactRole":"Principal Investigator" } ] } } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000007328", "InterventionMeshTerm":"Insulin" },{ "InterventionMeshId":"C000557859", "InterventionMeshTerm":"Insulin, Globin Zinc" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000007004", "InterventionAncestorTerm":"Hypoglycemic Agents" },{ "InterventionAncestorId":"D000045505", "InterventionAncestorTerm":"Physiological Effects of Drugs" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M8948", "InterventionBrowseLeafName":"Insulin", "InterventionBrowseLeafAsFound":"Insulin", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M178017", "InterventionBrowseLeafName":"Insulin, Globin Zinc", "InterventionBrowseLeafAsFound":"Insulin", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M16351", "InterventionBrowseLeafName":"Zinc", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M8637", "InterventionBrowseLeafName":"Hypoglycemic Agents", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"Hypo", "InterventionBrowseBranchName":"Hypoglycemic Agents" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" },{ "InterventionBrowseBranchAbbrev":"Micro", "InterventionBrowseBranchName":"Micronutrients" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000003930", "ConditionMeshTerm":"Diabetic Retinopathy" },{ "ConditionMeshId":"D000003920", "ConditionMeshTerm":"Diabetes Mellitus" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000044882", "ConditionAncestorTerm":"Glucose Metabolism Disorders" },{ "ConditionAncestorId":"D000008659", "ConditionAncestorTerm":"Metabolic Diseases" },{ "ConditionAncestorId":"D000004700", "ConditionAncestorTerm":"Endocrine System Diseases" },{ "ConditionAncestorId":"D000012164", "ConditionAncestorTerm":"Retinal Diseases" },{ "ConditionAncestorId":"D000005128", "ConditionAncestorTerm":"Eye Diseases" },{ "ConditionAncestorId":"D000003925", "ConditionAncestorTerm":"Diabetic Angiopathies" },{ "ConditionAncestorId":"D000014652", "ConditionAncestorTerm":"Vascular Diseases" },{ "ConditionAncestorId":"D000002318", "ConditionAncestorTerm":"Cardiovascular Diseases" },{ "ConditionAncestorId":"D000048909", "ConditionAncestorTerm":"Diabetes Complications" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M5698", "ConditionBrowseLeafName":"Diabetes Mellitus", "ConditionBrowseLeafAsFound":"Diabetes", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M13582", "ConditionBrowseLeafName":"Retinal Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M5708", "ConditionBrowseLeafName":"Diabetic Retinopathy", "ConditionBrowseLeafAsFound":"Diabetic Retinopathy", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M10222", "ConditionBrowseLeafName":"Metabolic Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M23990", "ConditionBrowseLeafName":"Glucose Metabolism Disorders", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M6445", "ConditionBrowseLeafName":"Endocrine System Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M6854", "ConditionBrowseLeafName":"Eye Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M5703", "ConditionBrowseLeafName":"Diabetic Angiopathies", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M15983", "ConditionBrowseLeafName":"Vascular Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M24591", "ConditionBrowseLeafName":"Diabetes Complications", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC18", "ConditionBrowseBranchName":"Nutritional and Metabolic Diseases" },{ "ConditionBrowseBranchAbbrev":"BC19", "ConditionBrowseBranchName":"Gland and Hormone Related Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC11", "ConditionBrowseBranchName":"Eye Diseases" },{ "ConditionBrowseBranchAbbrev":"BC14", "ConditionBrowseBranchName":"Heart and Blood Diseases" } ] } } } } } }