{ "FullStudy":{ "Rank":217933, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01514942", "OrgStudyIdInfo":{ "OrgStudyId":"MIvsDCI_PCOS/IR" }, "Organization":{ "OrgFullName":"AGUNCO Obstetrics and Gynecology Centre", "OrgClass":"OTHER" }, "BriefTitle":"Myo-inositol Versus D-chiro-inositol in the Treatment of Polycystic Ovary Syndrome and Insulin Resistance: Evaluation of Clinical, Metabolic, Endocrine and Ultrasound Parameters" }, "StatusModule":{ "StatusVerifiedDate":"January 2012", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StudyFirstSubmitDate":"January 13, 2012", "StudyFirstSubmitQCDate":"January 18, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 23, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"January 18, 2012", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"January 23, 2012", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"AGUNCO Obstetrics and Gynecology Centre", "LeadSponsorClass":"OTHER" } }, "OversightModule":{}, "DescriptionModule":{ "BriefSummary":"Insulin resistance has important implications in the pathogenesis of the polycystic ovary syndrome (PCOS) and insulin-sensitizing drugs are considered a useful therapeutic approach.\n\nReduction of insulin levels with administration of insulin sensitizing agents has been found to be beneficial in lowering both hyperinsulinemia, hyperandrogenemia, and restoring ovulation. Metformin alone or in combination with oral contraceptives (OCs) has been widely used in the long term treatment of women with PCOS in whom it modifies the ovarian morphology, improves intraovarian androgen levels, and enhances systemic and local insulin resistance. Despite to these beneficial effects, several side effects have been reported due to the long term administration of this drug.\n\nIn the recent years, inositol has found more and more space in the reproductive clinical practice. Indeed, inositol have been classified as \"insulin sensitizing agent\" and it is mainly used as a chronic treatment for PCOS. Inositol exists in 9 different isomers and in particular several studies on Myo-inositol and D-chiro-inositol were reported.\n\nIn this study myo-inositol versus D-chiro-inositol treatments were compared to placebo in women with PCOS and with or without insulin resistance." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "PCOS" ] }, "KeywordList":{ "Keyword":[ "PCOS", "Insulin resistance", "Myo-inositol", "D-chiro-inositol" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 4" ] } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Insulin resistant patients", "ArmGroupType":"Other", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Dietary Supplement: Myo-inositol + Folic acid", "Dietary Supplement: D-chiro-inositol, manganese, folic acid, vit B12", "Drug: Folic acid, vit B12" ] } },{ "ArmGroupLabel":"Non-insulin resistant patients", "ArmGroupType":"Other", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Dietary Supplement: Myo-inositol + Folic acid", "Dietary Supplement: D-chiro-inositol, manganese, folic acid, vit B12", "Drug: Folic acid, vit B12" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Dietary Supplement", "InterventionName":"Myo-inositol + Folic acid", "InterventionDescription":"Myo-inositol (2g) Folic acid (200mcg) (2 per day)", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Insulin resistant patients" ] } },{ "InterventionType":"Dietary Supplement", "InterventionName":"Myo-inositol + Folic acid", "InterventionDescription":"Myo-inositol (2g) Folic acid (200mcg) (2 per day)", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Non-insulin resistant patients" ] } },{ "InterventionType":"Dietary Supplement", "InterventionName":"D-chiro-inositol, manganese, folic acid, vit B12", "InterventionDescription":"D-Chiro-inositol (500 mg), manganese (1 mg), folic acid (200 mcg), vit B12 (1.25 mcg) (2 per day)", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Insulin resistant patients" ] } },{ "InterventionType":"Dietary Supplement", "InterventionName":"D-chiro-inositol, manganese, folic acid, vit B12", "InterventionDescription":"D-chiro-inositol (500 mg), manganese (1 mg), folic acid (200 mcg), vit B12 (1.25 mcg) (2 per day)", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Non-insulin resistant patients" ] } },{ "InterventionType":"Drug", "InterventionName":"Folic acid, vit B12", "InterventionDescription":"Folic acid (200 mcg), vit B12 (1.25 mcg) (2 per day)", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Insulin resistant patients" ] } },{ "InterventionType":"Drug", "InterventionName":"Folic acid, vit B12", "InterventionDescription":"Folic acid (200 mcg), vit B12 (1.25 mcg) (2 per day)", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Non-insulin resistant patients" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Body Mass Index (BMI)" },{ "PrimaryOutcomeMeasure":"Menstrual cycle" },{ "PrimaryOutcomeMeasure":"Score acne (acne grading system by Cremoncini et al)" },{ "PrimaryOutcomeMeasure":"Score hirsutism (Ferriman-Gallwey score)" },{ "PrimaryOutcomeMeasure":"Alopecia" },{ "PrimaryOutcomeMeasure":"Oral Glucose Tolerance Test (OGTT)" },{ "PrimaryOutcomeMeasure":"Glucagon levels" },{ "PrimaryOutcomeMeasure":"C-peptide test" },{ "PrimaryOutcomeMeasure":"Myo-inositol serum concentration" },{ "PrimaryOutcomeMeasure":"D-chiro-inositol serum concentration" },{ "PrimaryOutcomeMeasure":"Luteinizing Hormone (LH), Follicle Stimulating Hormone (FSH), and Estradiol (E2) levels test" },{ "PrimaryOutcomeMeasure":"Prolactin (PRL) levels test" },{ "PrimaryOutcomeMeasure":"Thyroid-stimulating hormone (TSH), free thyroid hormone (fT3 and fT4), and alpha-1 antitrypsin (AAT) test" },{ "PrimaryOutcomeMeasure":"Total and free testosterone levels" },{ "PrimaryOutcomeMeasure":"Sex hormone binding globulin (SHBG) test" },{ "PrimaryOutcomeMeasure":"17-Hydroxyprogesterone (17-OHP) levels" },{ "PrimaryOutcomeMeasure":"Dehydroepiandrosterone (DHEA) and DHEA-sulfate (DHEAS) levels" },{ "PrimaryOutcomeMeasure":"delta 4-androstenedione levels" },{ "PrimaryOutcomeMeasure":"progesterone levels" },{ "PrimaryOutcomeMeasure":"Adrenocorticotropic Hormone (ACTH) stimulation test" },{ "PrimaryOutcomeMeasure":"Ovarian size and morphology", "PrimaryOutcomeDescription":"Ovarian ultrasound scan for the assessment of size and morphology" },{ "PrimaryOutcomeMeasure":"Antral follicle counts" },{ "PrimaryOutcomeMeasure":"Stromal/Cortical ratio in the ovary" },{ "PrimaryOutcomeMeasure":"Endometrial thickness", "PrimaryOutcomeDescription":"Transvaginal ultrasound measurement of endometrial thickness performed between day 3 and 5 of the menstrual cycle." } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nWomen fulfilled two out of three diagnostic criteria for PCOS\n\nExclusion Criteria:\n\nWomen with pre-existing secondary endocrine disorders\nWomen with personal history of hypertension, diabetes mellitus or cardiovascular disorders\nWomen who received treatment with other drugs for the previous 6 months before entering the study.", "HealthyVolunteers":"No", "Gender":"Female", "MinimumAge":"20 Years", "MaximumAge":"40 Years", "StdAgeList":{ "StdAge":[ "Adult" ] } }, "ContactsLocationsModule":{ "LocationList":{ "Location":[ { "LocationFacility":"Istituto di Patologia Ostetrica e Ginecologica", "LocationCity":"Catania", "LocationCountry":"Italy" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"19499845", "ReferenceType":"background", "ReferenceCitation":"Costantino D, Minozzi G, Minozzi E, Guaraldi C. Metabolic and hormonal effects of myo-inositol in women with polycystic ovary syndrome: a double-blind trial. Eur Rev Med Pharmacol Sci. 2009 Mar-Apr;13(2):105-10." },{ "ReferencePMID":"20222840", "ReferenceType":"background", "ReferenceCitation":"Raffone E, Rizzo P, Benedetto V. Insulin sensitiser agents alone and in co-treatment with r-FSH for ovulation induction in PCOS women. Gynecol Endocrinol. 2010 Apr;26(4):275-80. doi: 10.3109/09513590903366996." },{ "ReferencePMID":"11900279", "ReferenceType":"background", "ReferenceCitation":"Larner J. D-chiro-inositol--its functional role in insulin action and its deficit in insulin resistance. Int J Exp Diabetes Res. 2002;3(1):47-60." },{ "ReferencePMID":"20811656", "ReferenceType":"background", "ReferenceCitation":"Larner J, Brautigan DL, Thorner MO. D-chiro-inositol glycans in insulin signaling and insulin resistance. Mol Med. 2010 Nov-Dec;16(11-12):543-52. doi: 10.2119/molmed.2010.00107. Epub 2010 Aug 27. Review." } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000005492", "InterventionMeshTerm":"Folic Acid" },{ "InterventionMeshId":"D000014803", "InterventionMeshTerm":"Vitamin B Complex" },{ "InterventionMeshId":"D000006879", "InterventionMeshTerm":"Hydroxocobalamin" },{ "InterventionMeshId":"D000014805", "InterventionMeshTerm":"Vitamin B 12" },{ "InterventionMeshId":"D000007294", "InterventionMeshTerm":"Inositol" },{ "InterventionMeshId":"D000008345", "InterventionMeshTerm":"Manganese" } ] }, "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" },{ "InterventionAncestorId":"D000014131", "InterventionAncestorTerm":"Trace Elements" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M7201", "InterventionBrowseLeafName":"Folic Acid", "InterventionBrowseLeafAsFound":"Folic acid", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M16131", "InterventionBrowseLeafName":"Vitamin B 12", "InterventionBrowseLeafAsFound":"Vit B12", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M8517", "InterventionBrowseLeafName":"Hydroxocobalamin", "InterventionBrowseLeafAsFound":"Vit B12", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M16129", "InterventionBrowseLeafName":"Vitamin B Complex", "InterventionBrowseLeafAsFound":"Folic acid", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M8919", "InterventionBrowseLeafName":"Inositol", "InterventionBrowseLeafAsFound":"Inositol", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M9918", "InterventionBrowseLeafName":"Manganese", "InterventionBrowseLeafAsFound":"Manganese", "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":"T476", "InterventionBrowseLeafName":"Vitamin B12", "InterventionBrowseLeafAsFound":"Vit B12", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"T441", "InterventionBrowseLeafName":"Cobalamin", "InterventionBrowseLeafAsFound":"Vit B12", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"T444", "InterventionBrowseLeafName":"Cyanocobalamin", "InterventionBrowseLeafAsFound":"Vit B12", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"T400", "InterventionBrowseLeafName":"Inositol", "InterventionBrowseLeafAsFound":"Inositol", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"T451", "InterventionBrowseLeafName":"Methylcobalamin", "InterventionBrowseLeafRelevance":"low" } ] }, "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":"D000007333", "ConditionMeshTerm":"Insulin Resistance" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000006946", "ConditionAncestorTerm":"Hyperinsulinism" },{ "ConditionAncestorId":"D000044882", "ConditionAncestorTerm":"Glucose Metabolism Disorders" },{ "ConditionAncestorId":"D000008659", "ConditionAncestorTerm":"Metabolic Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M14938", "ConditionBrowseLeafName":"Syndrome", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M8953", "ConditionBrowseLeafName":"Insulin Resistance", "ConditionBrowseLeafAsFound":"Insulin Resistance", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M12553", "ConditionBrowseLeafName":"Polycystic Ovary Syndrome", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M8580", "ConditionBrowseLeafName":"Hyperinsulinism", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M10222", "ConditionBrowseLeafName":"Metabolic Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M23990", "ConditionBrowseLeafName":"Glucose Metabolism Disorders", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC23", "ConditionBrowseBranchName":"Symptoms and General Pathology" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC18", "ConditionBrowseBranchName":"Nutritional and Metabolic Diseases" },{ "ConditionBrowseBranchAbbrev":"BC04", "ConditionBrowseBranchName":"Cancers and Other Neoplasms" },{ "ConditionBrowseBranchAbbrev":"BXS", "ConditionBrowseBranchName":"Urinary Tract, Sexual Organs, and Pregnancy Conditions" },{ "ConditionBrowseBranchAbbrev":"BC19", "ConditionBrowseBranchName":"Gland and Hormone Related Diseases" } ] } } } } } }