Ignite Creation Date:
2025-12-26 @ 12:19 PM
Ignite Modification Date:
2025-12-29 @ 4:15 PM
Study NCT ID:
NCT01046500
Status:
UNKNOWN
Last Update Posted:
2014-05-20
First Post:
2010-01-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Myo-inositol Versus Metformin Administration in Post-menopausal Women With Metabolic Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007294', 'term': 'Inositol'}, {'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D013402', 'term': 'Sugar Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-05-19', 'studyFirstSubmitDate': '2010-01-08', 'studyFirstSubmitQcDate': '2010-01-11', 'lastUpdatePostDateStruct': {'date': '2014-05-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'glycaemia, insulinaemia, HOMA-IR', 'timeFrame': 'at baseline and after 6 months'}], 'secondaryOutcomes': [{'measure': 'serum triglycerides, HDL and total cholesterol, blood pressure level, BMI and waist circumference', 'timeFrame': 'at baseline and after six months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['insulin resistance', 'body mass index', 'myo-inositol', 'serum triglycerides and cholesterol', 'blood pressure', 'metformin'], 'conditions': ['Metabolic Syndrome']}, 'descriptionModule': {'briefSummary': 'Myo-Inositol is classified as a member of the vitamin B complex. It is a constituent of living cells and is widespread in many food. It is involved in a number of biological processes, including insulin signal transduction, resulting in modulating insulin sensitivity. One hundred post-menopausal women from 50 to 60 years old, affected by metabolic syndrome (criteria are described in NIH ATP III) will be randomized into two groups: 50 treated with myo-inositol 2 g twice per day and fifty treated with metformin for six months. Metformin is the drug usually used in diabetic and pre-diabetic conditions, as metabolic syndrome. The investigators hypothesize that the administration of myo-inositol would improve the insulin-receptor activity in these women, reducing insulin resistance as well as metformin.\n\nOUTCOME MEASURE: HOMA-IR, blood pressure level, serum triglycerides and cholesterol, BMI and waist circumference'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Post-menopausal outpatients affected by the metabolic syndrome, whose criteria are described in NIH ATP III, 2001.\n\nExclusion Criteria:\n\n* Post-menopausal outpatients without metabolic syndrome\n* assumption of hypocholesterolemic or other insulin sensitizing drugs'}, 'identificationModule': {'nctId': 'NCT01046500', 'briefTitle': 'Myo-inositol Versus Metformin Administration in Post-menopausal Women With Metabolic Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'University of Messina'}, 'orgStudyIdInfo': {'id': 'INOMEN-2010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'metformin', 'interventionNames': ['Drug: Metformin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'myo-inositol', 'interventionNames': ['Dietary Supplement: myo-inositol']}], 'interventions': [{'name': 'myo-inositol', 'type': 'DIETARY_SUPPLEMENT', 'description': '2 grams twice a day', 'armGroupLabels': ['myo-inositol']}, {'name': 'Metformin', 'type': 'DRUG', 'description': 'pill, 250 mg, twice a day', 'armGroupLabels': ['metformin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Messina', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': "Rosario D'Anna, associate professor", 'role': 'CONTACT', 'email': 'rosariodanna@tin.it', 'phone': '+39 090 2217324'}, {'name': "Rosario D'Anna, associate professor", 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital', 'geoPoint': {'lat': 38.19394, 'lon': 15.55256}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Messina', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': "Rosario D'anna", 'investigatorAffiliation': 'University of Messina'}}}}