{ "FullStudy":{ "Rank":218169, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01511835", "OrgStudyIdInfo":{ "OrgStudyId":"MyoIN_diab" }, "Organization":{ "OrgFullName":"AGUNCO Obstetrics and Gynecology Centre", "OrgClass":"OTHER" }, "BriefTitle":"Efficacy of Myo-inositol in Preventing Gestational Diabetes in High-risk Pregnant Women" }, "StatusModule":{ "StatusVerifiedDate":"January 2012", "OverallStatus":"Unknown status", "LastKnownStatus":"Recruiting", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StudyFirstSubmitDate":"November 16, 2011", "StudyFirstSubmitQCDate":"January 13, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 19, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"January 13, 2012", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"January 19, 2012", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"AGUNCO Obstetrics and Gynecology Centre", "LeadSponsorClass":"OTHER" } }, "OversightModule":{}, "DescriptionModule":{ "BriefSummary":"The aim of this study is to evaluate the efficacy of myo-inositol in preventing gestational diabetes in high risk pregnant women." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Gestational Diabetes" ] }, "KeywordList":{ "Keyword":[ "diabetes", "pregnancy", "myo-inositol" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 4" ] } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Myo-inositol powder", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Dietary Supplement: inositol + folic acid" ] } },{ "ArmGroupLabel":"Myo-inositol soft gel capsules", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Dietary Supplement: inositol + folic acid" ] } },{ "ArmGroupLabel":"Folic acid", "ArmGroupType":"Placebo Comparator", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Folic Acid" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Dietary Supplement", "InterventionName":"inositol + folic acid", "InterventionDescription":"2000 mg of inositol+200mcg of folic acid; 2 per diem", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Myo-inositol powder" ] } },{ "InterventionType":"Dietary Supplement", "InterventionName":"inositol + folic acid", "InterventionDescription":"600 mg of inositol + 200mcg of folic acid; 2 cp per diem", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Myo-inositol soft gel capsules" ] } },{ "InterventionType":"Drug", "InterventionName":"Folic Acid", "InterventionDescription":"Folic Acid 400mcg; 1 cp/die", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Folic acid" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"OGTT", "PrimaryOutcomeDescription":"The diagnostic 75g oral glucose tolerance test (OGTT) is performed between 24 and 28 weeks of gestation." } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Number of pregnant women with gestational diabetes" },{ "SecondaryOutcomeMeasure":"Number of pregnant women requiring insulin treatment" },{ "SecondaryOutcomeMeasure":"Weight gain at the end of pregnancy" },{ "SecondaryOutcomeMeasure":"Number of newborn infants whose weight is more than 4000 g" },{ "SecondaryOutcomeMeasure":"Number of newborn infants requiring Neonatal Intensive Care (NIC)" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\n60 women in their first trimester of pregnancy affected by one or more of the following risk factors:\n\nGlycemia levels > 92 mg/dl\nBMI > 30\nAt least a parent or a brother (or sister)affected by diabetes\nPre-existing pregnancy with gestational diabetes\n\nExclusion Criteria:\n\nPregnant women affected by pregestational diabetes\nTwin pregnancy\nPatients affected by pre-existing diseases in pregnancy (diabetes excluded)\nPatients affected by chronic disorders", "Gender":"Female", "MinimumAge":"20 Years", "MaximumAge":"45 Years", "StdAgeList":{ "StdAge":[ "Adult" ] } }, "ContactsLocationsModule":{ "CentralContactList":{ "CentralContact":[ { "CentralContactName":"Vittorio Unfer", "CentralContactRole":"Contact", "CentralContactEMail":"vunfer@gmail.com" },{ "CentralContactName":"Gianfranco Carlomagno", "CentralContactRole":"Contact", "CentralContactEMail":"gianfranco.carlomagno@agunco.it" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"AGUNCO", "LocationStatus":"Recruiting", "LocationCity":"Rome", "LocationZip":"00155", "LocationCountry":"Italy", "LocationContactList":{ "LocationContact":[ { "LocationContactName":"Gianfranco Carlomagno", "LocationContactRole":"Contact", "LocationContactEMail":"gianfranco.carlomagno@agunco.it" },{ "LocationContactName":"Vittorio Unfer", "LocationContactRole":"Principal Investigator" },{ "LocationContactName":"Gianfranco Carlomagno", "LocationContactRole":"Principal Investigator" } ] } } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"19800728", "ReferenceType":"background", "ReferenceCitation":"Papaleo E, Unfer V, Baillargeon JP, Chiu TT. Contribution of myo-inositol to reproduction. Eur J Obstet Gynecol Reprod Biol. 2009 Dec;147(2):120-3. doi: 10.1016/j.ejogrb.2009.09.008. Epub 2009 Oct 2. Review." },{ "ReferencePMID":"21414183", "ReferenceType":"background", "ReferenceCitation":"Corrado F, D'Anna R, Di Vieste G, Giordano D, Pintaudi B, Santamaria A, Di Benedetto A. The effect of myoinositol supplementation on insulin resistance in patients with gestational diabetes. Diabet Med. 2011 Aug;28(8):972-5. doi: 10.1111/j.1464-5491.2011.03284.x." } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000005492", "InterventionMeshTerm":"Folic Acid" },{ "InterventionMeshId":"D000014803", "InterventionMeshTerm":"Vitamin B Complex" },{ "InterventionMeshId":"D000007294", "InterventionMeshTerm":"Inositol" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000006397", "InterventionAncestorTerm":"Hematinics" },{ "InterventionAncestorId":"D000014815", "InterventionAncestorTerm":"Vitamins" },{ "InterventionAncestorId":"D000018977", "InterventionAncestorTerm":"Micronutrients" },{ "InterventionAncestorId":"D000078622", "InterventionAncestorTerm":"Nutrients" },{ "InterventionAncestorId":"D000006133", "InterventionAncestorTerm":"Growth Substances" },{ "InterventionAncestorId":"D000045505", "InterventionAncestorTerm":"Physiological Effects of Drugs" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M7201", "InterventionBrowseLeafName":"Folic Acid", "InterventionBrowseLeafAsFound":"Folic acid", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M16129", "InterventionBrowseLeafName":"Vitamin B Complex", "InterventionBrowseLeafAsFound":"Folic acid", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M8919", "InterventionBrowseLeafName":"Inositol", "InterventionBrowseLeafAsFound":"Inositol", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M16141", "InterventionBrowseLeafName":"Vitamins", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M8068", "InterventionBrowseLeafName":"Hematinics", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M15468", "InterventionBrowseLeafName":"Trace Elements", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19593", "InterventionBrowseLeafName":"Micronutrients", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M1986", "InterventionBrowseLeafName":"Nutrients", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"T446", "InterventionBrowseLeafName":"Folic Acid", "InterventionBrowseLeafAsFound":"Folic acid", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"T447", "InterventionBrowseLeafName":"Folinic Acid", "InterventionBrowseLeafAsFound":"Folic acid", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"T448", "InterventionBrowseLeafName":"Folate", "InterventionBrowseLeafAsFound":"Folic acid", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"T475", "InterventionBrowseLeafName":"Vitamin B9", "InterventionBrowseLeafAsFound":"Folic acid", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"T400", "InterventionBrowseLeafName":"Inositol", "InterventionBrowseLeafAsFound":"Inositol", "InterventionBrowseLeafRelevance":"high" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"Micro", "InterventionBrowseBranchName":"Micronutrients" },{ "InterventionBrowseBranchAbbrev":"Hemat", "InterventionBrowseBranchName":"Hematinics" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" },{ "InterventionBrowseBranchAbbrev":"Vi", "InterventionBrowseBranchName":"Vitamins" },{ "InterventionBrowseBranchAbbrev":"Ot", "InterventionBrowseBranchName":"Other Dietary Supplements" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000016640", "ConditionMeshTerm":"Diabetes, Gestational" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000003920", "ConditionAncestorTerm":"Diabetes Mellitus" },{ "ConditionAncestorId":"D000044882", "ConditionAncestorTerm":"Glucose Metabolism Disorders" },{ "ConditionAncestorId":"D000008659", "ConditionAncestorTerm":"Metabolic Diseases" },{ "ConditionAncestorId":"D000004700", "ConditionAncestorTerm":"Endocrine System Diseases" },{ "ConditionAncestorId":"D000011248", "ConditionAncestorTerm":"Pregnancy Complications" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M5698", "ConditionBrowseLeafName":"Diabetes Mellitus", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M17595", "ConditionBrowseLeafName":"Diabetes, Gestational", "ConditionBrowseLeafAsFound":"Gestational Diabetes", "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":"M12710", "ConditionBrowseLeafName":"Pregnancy 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":"BXS", "ConditionBrowseBranchName":"Urinary Tract, Sexual Organs, and Pregnancy Conditions" } ] } } } } } }