Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-01-01 @ 10:09 AM
Study NCT ID:
NCT02097069
Status:
UNKNOWN
Last Update Posted:
2014-03-26
First Post:
2014-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Inositol Stereoisomers to Treat Gestational Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016640', 'term': 'Diabetes, Gestational'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005492', 'term': 'Folic Acid'}, {'id': 'D007294', 'term': 'Inositol'}], 'ancestors': [{'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'}, {'id': 'D013402', 'term': 'Sugar Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'lastUpdateSubmitDate': '2014-03-23', 'studyFirstSubmitDate': '2014-02-27', 'studyFirstSubmitQcDate': '2014-03-23', 'lastUpdatePostDateStruct': {'date': '2014-03-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Insulin resistance level evaluated by homeostasis model assessment of insulin resistance (HOMA-IR)', 'timeFrame': '56 days- 8 weeks'}], 'secondaryOutcomes': [{'measure': 'hypertensive disorders', 'timeFrame': '56 days- 8 weeks'}, {'measure': 'macrosomia', 'timeFrame': 'at delivery'}, {'measure': 'cesarean section', 'timeFrame': 'at delivery'}, {'measure': 'neonatal hypoglycemia', 'timeFrame': 'at delivery'}, {'measure': 'jaundice requiring phototherapy', 'timeFrame': 'within the first 2 weeks after delivery'}, {'measure': 'lipid profile', 'timeFrame': '56 days- 8 weeks'}, {'measure': 'insulin therapy requirements', 'timeFrame': '56 days- 8 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Gestational diabetes mellitus', 'Myo-inositol', 'D-chiro-inositol', 'Insulin resistance'], 'conditions': ['Gestational Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '9704245', 'type': 'BACKGROUND', 'citation': 'Metzger BE, Coustan DR. Summary and recommendations of the Fourth International Workshop-Conference on Gestational Diabetes Mellitus. The Organizing Committee. Diabetes Care. 1998 Aug;21 Suppl 2:B161-7. No abstract available.'}, {'pmid': '9397092', 'type': 'BACKGROUND', 'citation': 'Casey BM, Lucas MJ, Mcintire DD, Leveno KJ. Pregnancy outcomes in women with gestational diabetes compared with the general obstetric population. Obstet Gynecol. 1997 Dec;90(6):869-73. doi: 10.1016/s0029-7844(97)00542-5.'}, {'pmid': '11722247', 'type': 'BACKGROUND', 'citation': 'Jovanovic L, Pettitt DJ. Gestational diabetes mellitus. JAMA. 2001 Nov 28;286(20):2516-8. doi: 10.1001/jama.286.20.2516. No abstract available.'}, {'pmid': '10219066', 'type': 'BACKGROUND', 'citation': 'Nestler JE, Jakubowicz DJ, Reamer P, Gunn RD, Allan G. Ovulatory and metabolic effects of D-chiro-inositol in the polycystic ovary syndrome. N Engl J Med. 1999 Apr 29;340(17):1314-20. doi: 10.1056/NEJM199904293401703.'}, {'pmid': '23764390', 'type': 'BACKGROUND', 'citation': 'Croze ML, Soulage CO. Potential role and therapeutic interests of myo-inositol in metabolic diseases. Biochimie. 2013 Oct;95(10):1811-27. doi: 10.1016/j.biochi.2013.05.011. Epub 2013 Jun 10.'}, {'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': '29774465', 'type': 'DERIVED', 'citation': 'Fraticelli F, Celentano C, Zecca IA, Di Vieste G, Pintaudi B, Liberati M, Franzago M, Di Nicola M, Vitacolonna E. Effect of inositol stereoisomers at different dosages in gestational diabetes: an open-label, parallel, randomized controlled trial. Acta Diabetol. 2018 Aug;55(8):805-812. doi: 10.1007/s00592-018-1157-4. Epub 2018 May 17.'}]}, 'descriptionModule': {'briefSummary': 'The investigators aim to compare the effect of different inositol stereoisomers supplementation in lowering insulin resistance levels after 8 weeks of treatment in pregnant women with GDM and in preventing adverse obstetric outcomes.\n\nThe study population includes 80 women with GDM, randomly allocated to subgroup A (folic acid 400 mcg/day), subgroup B (myo-inositol 2000 mg twice a day), subgroup C (D-chiro-inositol 250 mg twice a day), and subgroup D (Myo-inositol plus D-chiro-inositol 550mg/13,8 mg twice a day).\n\nFolic acid or inositol stereoisomers will be administered starting at the enrolling time (24-28 week gestation, after GDM diagnosis) till the delivery.\n\nThe homeostasis model assessment of insulin resistance (HOMA-IR) and the sensitivity index (QUICKI) will be checked at the moment of the diagnostic oral glucose tolerance test (24-28 weeks) and after 8 weeks of treatment. Obstetric outcomes, the rate of women needed insulin therapy and insulin dosage will be registered.', 'detailedDescription': "Gestational diabetes mellitus (GDM) is defined as carbohydrate intolerance that begins or is first recognized during pregnancy (1). It is characterized by an increase of physiological insulin resistance and it is associated with an increased risk of perinatal and maternal morbidity (2,3).\n\nInositol is a six-carbon polyol, normally present in a variety of foods, which has been classified as an insulin sensitizing agent. It exists as nine different isomers including myo-inositol (MI) and D-chiro-inositol (DCI) that are the most represented in human body. Myo-inositol and D-chiro-inositol glycans administration has been reported to exert beneficial effects at metabolic, hormonal and ovarian levels (4-5).\n\nRecently has been demonstrated that Myo-inositol supplementation improves insulin resistance in patients with GDM (6), whereas there aren't data about the use of D-chiro-inositol or Myo-inositol plus D-chiro-inositol in women affected by GDM.\n\nIn this proposed study, the investigators aim to compare the effect of different inositol stereoisomers supplementation (Myo-inositol, D-chiro-inositol or Myo-inositol plus D-chiro-inositol ) in lowering insulin resistance levels after 8 weeks of treatment in pregnant women with GDM and in preventing adverse obstetric outcomes. All the available inositol formulations also contain folic acid (200 mcg).\n\nThe study population includes 80 women with GDM, randomly allocated to subgroup A (folic acid 400 mcg/day), subgroup B (myo-inositol 2000 mg twice a day), subgroup C (D-chiro-inositol 250 mg twice a day), and subgroup D (Myo-inositol plus D-chiro-inositol 550mg/13,8 mg twice a day).\n\nDietary control, folic acid or inositol stereoisomers will be administered starting at the enrolling time (24-28 week gestation, after GDM diagnosis) till the delivery.\n\nThe homeostasis model assessment of insulin resistance (HOMA-IR) and the sensitivity index (QUICKI) will be checked at the moment of the diagnostic oral glucose tolerance test (24-28 weeks) and after 8 weeks of treatment. Obstetric outcomes, the rate of women needed insulin therapy and insulin dosage will be registered."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gestational Diabetes diagnosed within 24-28 weeks gestation\n* Caucasian pregnant women\n\nExclusion Criteria:\n\n* Pre-pregnancy diabetes\n* Non-singleton pregnancy'}, 'identificationModule': {'nctId': 'NCT02097069', 'briefTitle': 'Inositol Stereoisomers to Treat Gestational Diabetes', 'organization': {'class': 'OTHER', 'fullName': "Università degli Studi 'G. d'Annunzio' Chieti e Pescara"}, 'officialTitle': 'Different Effects of Inositol Stereoisomers on Insulin Sensitivity in Women With Gestational Diabetes', 'orgStudyIdInfo': {'id': 'VITA01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Subgroup A', 'description': 'folic acid 400 mcg/day', 'interventionNames': ['Dietary Supplement: Folic acid']}, {'type': 'EXPERIMENTAL', 'label': 'Subgroup B', 'description': 'myo-inositol 2000 mg twice a day', 'interventionNames': ['Dietary Supplement: Myo-inositol']}, {'type': 'EXPERIMENTAL', 'label': 'Subgroup C', 'description': 'D-chiro-inositol 250 mg twice a day', 'interventionNames': ['Dietary Supplement: D-Chiro-inositol']}, {'type': 'EXPERIMENTAL', 'label': 'Subgroup D', 'description': 'Myo-inositol plus D-chiro inositol 550mg/13,8 mg twice a day', 'interventionNames': ['Dietary Supplement: Myo-inositol plus D-chiro inositol']}], 'interventions': [{'name': 'Folic acid', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Folic acid 400 mcg/day', 'armGroupLabels': ['Subgroup A']}, {'name': 'Myo-inositol', 'type': 'DIETARY_SUPPLEMENT', 'description': 'myo-inositol 2000 mg twice a day', 'armGroupLabels': ['Subgroup B']}, {'name': 'D-Chiro-inositol', 'type': 'DIETARY_SUPPLEMENT', 'description': 'D-chiro inositol 250 mg twice a day', 'armGroupLabels': ['Subgroup C']}, {'name': 'Myo-inositol plus D-chiro inositol', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Myo-inositol plus D-chiro inositol 550mg/13,8 mg twice a day', 'armGroupLabels': ['Subgroup D']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66100', 'city': 'Chieti', 'state': 'Chieti', 'country': 'Italy', 'contacts': [{'name': 'Ester Vitacolonna, Professor', 'role': 'CONTACT', 'email': 'e.vitacolonna@unich.it', 'phone': '+393398073446'}, {'name': 'Ester Vitacolonna, Professor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital "SS Annunziata"', 'geoPoint': {'lat': 42.34827, 'lon': 14.16494}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Università degli Studi 'G. d'Annunzio' Chieti e Pescara", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Ester Vitacolonna', 'investigatorFullName': 'Ester Vitacolonna', 'investigatorAffiliation': "Università degli Studi 'G. d'Annunzio' Chieti e Pescara"}}}}