{ "FullStudy":{ "Rank":217696, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01518023", "OrgStudyIdInfo":{ "OrgStudyId":"Lessdiabetes" }, "Organization":{ "OrgFullName":"University of Sao Paulo", "OrgClass":"OTHER" }, "BriefTitle":"Long Term Diabetes Improvement After Cancer Gastrectomy and Colectomy", "OfficialTitle":"Long Term Diabetes Improvement After Cancer Gastrectomy and Colectomy" }, "StatusModule":{ "StatusVerifiedDate":"January 2012", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"January 2011" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"December 2011", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"December 2011", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 20, 2012", "StudyFirstSubmitQCDate":"January 24, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 25, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"January 24, 2012", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"January 25, 2012", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Principal Investigator", "ResponsiblePartyInvestigatorFullName":"Joel Faintuch", "ResponsiblePartyInvestigatorTitle":"Associate Professor, Department of Gastroenterology", "ResponsiblePartyInvestigatorAffiliation":"University of Sao Paulo" }, "LeadSponsor":{ "LeadSponsorName":"University of Sao Paulo", "LeadSponsorClass":"OTHER" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"There is evidence that gastrointestinal operations for non weight-losing purposes are beneficial for diabetes mellitus. Aiming to analyze such hypothesis, patients submitted to gastric bypass for morbid obesity, gastrectomy for gastric cancer and colectomy for colo-rectal cancer will be compared. The end point will be changes in fasting blood glucose and hemoglobin A1c concentration.", "DetailedDescription":"In a prospective protocol with retrospective information, patients (N=240) undergoing bariatric Roux-en-Y gastric bypass (n=80), cancer subtotal or total gastrectomy (n=80) and right colectomy or rectosigmoidectomy (n=80) with follow-up >3 years free of disease, with or without previously impaired fasting blood glucose, will be recruited. Patients will be submitted to a questionnaire involving diet, diagnosis of diabetes and glucose-lowering drugs, body weight and other clinical items. Preoperative information available in the hospital system will be completed and current findings will be updated, including body mass index and biochemical measurements. Using the outcomes of the bariatric population as benchmark, both concerning diabetics that were ameliorated and nondiabetics that progressed to new-onset diabetes,results in the other groups will be compared. The study should answer whether gastric and colorectal surgery for cancer 1) Are beneficial for established diabetes; 2) Attenuate the conversion of normal patients to diabetes, both within a follow-up period of 3- 12 years;" }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Diabetes Mellitus", "Prediabetes", "Morbid Obesity", "Gastric Cancer", "Colorectal Cancer" ] }, "KeywordList":{ "Keyword":[ "diabetes mellitus", "prediabetes", "fasting blood glucose", "HbA1c", "Roux en Y gastric bypass", "Cancer gastrectomy", "Cancer colorectal surgery" ] } }, "DesignModule":{ "StudyType":"Observational", "DesignInfo":{ "DesignObservationalModelList":{ "DesignObservationalModel":[ "Cohort" ] }, "DesignTimePerspectiveList":{ "DesignTimePerspective":[ "Prospective" ] } }, "EnrollmentInfo":{ "EnrollmentCount":"240", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Cancer gastrectomy", "ArmGroupDescription":"Patients previously submitted to partial/total gastrectomy for gastric cancer", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Other: Interview, questionnaire, updated biochemical tests" ] } },{ "ArmGroupLabel":"Colorectal cancer operation", "ArmGroupDescription":"Patients previously submitted to right colectomy or rectosignoidectomy for cancer", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Other: Interview, questionnaire, updated biochemical tests" ] } },{ "ArmGroupLabel":"Bariatric patients", "ArmGroupDescription":"Morbidly obese participants who underwent antiobesity Roux-en-Y gastric bypass", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Other: Interview, questionnaire, updated biochemical tests" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Other", "InterventionName":"Interview, questionnaire, updated biochemical tests", "InterventionDescription":"Patients will be interviewed and questioned about nutritional status, diet, drugs and diagnosis/clinical course of diabetes. Routine biochemical tests will be searched and if necessary updated.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Bariatric patients", "Cancer gastrectomy", "Colorectal cancer operation" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Fasting blood glucose", "PrimaryOutcomeDescription":"Glucose improvement or deterioration comparing preoperative versus late postoperative value. Classification according to the American Diabetes Association", "PrimaryOutcomeTimeFrame":"3-12 years change" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"HbA1c", "SecondaryOutcomeDescription":"Same as fasting blood glucose (preoperative versus current change). Classification according to the American Diabetes Association.", "SecondaryOutcomeTimeFrame":"3-12 years" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nFollow-up period > 3 years,\nweight stable in the last year\n\nExclusion Criteria:\n\nReoperation or take-down of original operation,\nconsumptive diseases,\nprotein-calorie malnutrition,\norgan failures,\npancreatic surgery,\ncell or organ transplantation,\ntype 1 diabetes,\ncognitive impairment or Alzheimer disease,\nrefusal to participate in the protocol", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] }, "StudyPopulation":"Adult males and females submitted to elective curative operations will be enrolled", "SamplingMethod":"Non-Probability Sample" }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Joel Faintuch, MD, PhD", "OverallOfficialAffiliation":"Hospital das Clinicas, Sao Paulo, Brazil", "OverallOfficialRole":"Study Chair" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Hospital das Clinicas- Central Institute ICHC- 9th Floor Rm 9077", "LocationCity":"Sao Paulo", "LocationZip":"05403-900", "LocationCountry":"Brazil" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"20707737", "ReferenceType":"background", "ReferenceCitation":"Faintuch J, Yamaguchi CM, Dias MC, Santo MA, Faintuch JJ, Cecconello I. Biochemical correlates of bariatric-responsive diabetes. Diabetes Technol Ther. 2010 Sep;12(9):707-15. doi: 10.1089/dia.2010.0018." },{ "ReferencePMID":"22228970", "ReferenceType":"background", "ReferenceCitation":"Kim JW, Cheong JH, Hyung WJ, Choi SH, Noh SH. Outcome after gastrectomy in gastric cancer patients with type 2 diabetes. World J Gastroenterol. 2012 Jan 7;18(1):49-54. doi: 10.3748/wjg.v18.i1.49." },{ "ReferencePMID":"23436087", "ReferenceType":"derived", "ReferenceCitation":"Hayashi SY, Faintuch J, Yagi OK, Yamaguchi CM, Faintuch JJ, Cecconello I. Does Roux-en-Y gastrectomy for gastric cancer influence glucose homeostasis in lean patients? Surg Endosc. 2013 Aug;27(8):2829-35. doi: 10.1007/s00464-013-2829-3. Epub 2013 Feb 23." } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000003920", "ConditionMeshTerm":"Diabetes Mellitus" },{ "ConditionMeshId":"D000011236", "ConditionMeshTerm":"Prediabetic State" },{ "ConditionMeshId":"D000018149", "ConditionMeshTerm":"Glucose Intolerance" },{ "ConditionMeshId":"D000009767", "ConditionMeshTerm":"Obesity, Morbid" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000044882", "ConditionAncestorTerm":"Glucose Metabolism Disorders" },{ "ConditionAncestorId":"D000008659", "ConditionAncestorTerm":"Metabolic Diseases" },{ "ConditionAncestorId":"D000004700", "ConditionAncestorTerm":"Endocrine System Diseases" },{ "ConditionAncestorId":"D000006943", "ConditionAncestorTerm":"Hyperglycemia" },{ "ConditionAncestorId":"D000009765", "ConditionAncestorTerm":"Obesity" },{ "ConditionAncestorId":"D000044343", "ConditionAncestorTerm":"Overnutrition" },{ "ConditionAncestorId":"D000009748", "ConditionAncestorTerm":"Nutrition Disorders" },{ "ConditionAncestorId":"D000050177", "ConditionAncestorTerm":"Overweight" },{ "ConditionAncestorId":"D000001835", "ConditionAncestorTerm":"Body Weight" },{ "ConditionAncestorId":"D000012816", "ConditionAncestorTerm":"Signs and Symptoms" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M11284", "ConditionBrowseLeafName":"Obesity", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M11285", "ConditionBrowseLeafName":"Obesity, Morbid", "ConditionBrowseLeafAsFound":"Morbid Obesity", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M5698", "ConditionBrowseLeafName":"Diabetes Mellitus", "ConditionBrowseLeafAsFound":"Diabetes Mellitus", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M14647", "ConditionBrowseLeafName":"Stomach Neoplasms", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M12700", "ConditionBrowseLeafName":"Prediabetic State", "ConditionBrowseLeafAsFound":"Prediabetes", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M18878", "ConditionBrowseLeafName":"Glucose Intolerance", "ConditionBrowseLeafAsFound":"Prediabetes", "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":"M8577", "ConditionBrowseLeafName":"Hyperglycemia", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M23894", "ConditionBrowseLeafName":"Overnutrition", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M11267", "ConditionBrowseLeafName":"Nutrition Disorders", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M24773", "ConditionBrowseLeafName":"Overweight", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M3696", "ConditionBrowseLeafName":"Body Weight", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"T5511", "ConditionBrowseLeafName":"Stomach Cancer", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC18", "ConditionBrowseBranchName":"Nutritional and Metabolic Diseases" },{ "ConditionBrowseBranchAbbrev":"BC23", "ConditionBrowseBranchName":"Symptoms and General Pathology" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC19", "ConditionBrowseBranchName":"Gland and Hormone Related Diseases" },{ "ConditionBrowseBranchAbbrev":"BC04", "ConditionBrowseBranchName":"Cancers and Other Neoplasms" },{ "ConditionBrowseBranchAbbrev":"BC06", "ConditionBrowseBranchName":"Digestive System Diseases" },{ "ConditionBrowseBranchAbbrev":"Rare", "ConditionBrowseBranchName":"Rare Diseases" } ] } } } } } }