Ignite Creation Date:
2025-12-24 @ 10:36 PM
Ignite Modification Date:
2025-12-25 @ 8:08 PM
Study NCT ID:
NCT01511835
Status:
UNKNOWN
Last Update Posted:
2012-01-19
First Post:
2011-11-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Myo-inositol in Preventing Gestational Diabetes in High-risk Pregnant Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016640', 'term': 'Diabetes, Gestational'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007294', 'term': 'Inositol'}, {'id': 'D005492', 'term': 'Folic Acid'}], 'ancestors': [{'id': 'D013402', 'term': 'Sugar Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL'}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'lastUpdateSubmitDate': '2012-01-13', 'studyFirstSubmitDate': '2011-11-16', 'studyFirstSubmitQcDate': '2012-01-13', 'lastUpdatePostDateStruct': {'date': '2012-01-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'OGTT', 'description': 'The diagnostic 75g oral glucose tolerance test (OGTT) is performed between 24 and 28 weeks of gestation.'}], 'secondaryOutcomes': [{'measure': 'Number of pregnant women with gestational diabetes'}, {'measure': 'Number of pregnant women requiring insulin treatment'}, {'measure': 'Weight gain at the end of pregnancy'}, {'measure': 'Number of newborn infants whose weight is more than 4000 g'}, {'measure': 'Number of newborn infants requiring Neonatal Intensive Care (NIC)'}]}, 'conditionsModule': {'keywords': ['diabetes', 'pregnancy', 'myo-inositol'], 'conditions': ['Gestational Diabetes']}, 'referencesModule': {'references': [{'pmid': '19800728', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '21414183', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '36790138', 'type': 'DERIVED', 'citation': 'Motuhifonua SK, Lin L, Alsweiler J, Crawford TJ, Crowther CA. Antenatal dietary supplementation with myo-inositol for preventing gestational diabetes. Cochrane Database Syst Rev. 2023 Feb 15;2(2):CD011507. doi: 10.1002/14651858.CD011507.pub3.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the efficacy of myo-inositol in preventing gestational diabetes in high risk pregnant women.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n60 women in their first trimester of pregnancy affected by one or more of the following risk factors:\n\n* Glycemia levels \\> 92 mg/dl\n* BMI \\> 30\n* At least a parent or a brother (or sister)affected by diabetes\n* Pre-existing pregnancy with gestational diabetes\n\nExclusion Criteria:\n\n* Pregnant women affected by pregestational diabetes\n* Twin pregnancy\n* Patients affected by pre-existing diseases in pregnancy (diabetes excluded)\n* Patients affected by chronic disorders'}, 'identificationModule': {'nctId': 'NCT01511835', 'briefTitle': 'Efficacy of Myo-inositol in Preventing Gestational Diabetes in High-risk Pregnant Women', 'organization': {'class': 'OTHER', 'fullName': 'AGUNCO Obstetrics and Gynecology Centre'}, 'orgStudyIdInfo': {'id': 'MyoIN_diab'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Myo-inositol powder', 'interventionNames': ['Dietary Supplement: inositol + folic acid']}, {'type': 'EXPERIMENTAL', 'label': 'Myo-inositol soft gel capsules', 'interventionNames': ['Dietary Supplement: inositol + folic acid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Folic acid', 'interventionNames': ['Drug: Folic Acid']}], 'interventions': [{'name': 'inositol + folic acid', 'type': 'DIETARY_SUPPLEMENT', 'description': '2000 mg of inositol+200mcg of folic acid; 2 per diem', 'armGroupLabels': ['Myo-inositol powder']}, {'name': 'inositol + folic acid', 'type': 'DIETARY_SUPPLEMENT', 'description': '600 mg of inositol + 200mcg of folic acid; 2 cp per diem', 'armGroupLabels': ['Myo-inositol soft gel capsules']}, {'name': 'Folic Acid', 'type': 'DRUG', 'description': 'Folic Acid 400mcg; 1 cp/die', 'armGroupLabels': ['Folic acid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00155', 'city': 'Rome', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Gianfranco Carlomagno', 'role': 'CONTACT', 'email': 'gianfranco.carlomagno@agunco.it'}, {'name': 'Vittorio Unfer', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Gianfranco Carlomagno', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'AGUNCO', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'centralContacts': [{'name': 'Vittorio Unfer', 'role': 'CONTACT', 'email': 'vunfer@gmail.com'}, {'name': 'Gianfranco Carlomagno', 'role': 'CONTACT', 'email': 'gianfranco.carlomagno@agunco.it'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AGUNCO Obstetrics and Gynecology Centre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}