Ignite Creation Date:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2025-12-29 @ 7:10 PM
Study NCT ID:
NCT01368328
Status:
UNKNOWN
Last Update Posted:
2011-06-07
First Post:
2011-04-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of the Chromium Nicotinate on Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'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': 'C102874', 'term': 'chromium nicotinic acid complex'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 57}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'completionDateStruct': {'date': '2011-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-06-06', 'studyFirstSubmitDate': '2011-04-12', 'studyFirstSubmitQcDate': '2011-06-06', 'lastUpdatePostDateStruct': {'date': '2011-06-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Insulin Sensitivity as assessed with homeostatic model assessment (HOMA)', 'timeFrame': 'baseline, 45 days and 90 days'}], 'secondaryOutcomes': [{'measure': 'fasting triglycerides, high density lipoprotein cholesterol, low density lipoprotein cholesterol', 'timeFrame': 'baseline, 45 days and 90 days'}, {'measure': 'body weight', 'timeFrame': 'baseline, 45 days, 90 days'}, {'measure': 'body fat accessed with bioimpedance', 'timeFrame': 'baseline, 45 days, 90 days'}, {'measure': 'waist circumference', 'timeFrame': 'baseline, 45 days, 90 days'}, {'measure': 'urea and creatinine', 'timeFrame': 'baseline, 45 days, 90 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Type 2 Diabetes', 'Chromium', 'Insulin resistance'], 'conditions': ['Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '19087394', 'type': 'BACKGROUND', 'citation': 'Anderson RA. Chromium and insulin resistance. Nutr Res Rev. 2003 Dec;16(2):267-75. doi: 10.1079/NRR200366.'}, {'pmid': '17303791', 'type': 'BACKGROUND', 'citation': 'Kleefstra N, Houweling ST, Bakker SJ, Verhoeven S, Gans RO, Meyboom-de Jong B, Bilo HJ. Chromium treatment has no effect in patients with type 2 diabetes in a Western population: a randomized, double-blind, placebo-controlled trial. Diabetes Care. 2007 May;30(5):1092-6. doi: 10.2337/dc06-2192. Epub 2007 Feb 15.'}, {'pmid': '16505499', 'type': 'BACKGROUND', 'citation': 'Kleefstra N, Houweling ST, Jansman FG, Groenier KH, Gans RO, Meyboom-de Jong B, Bakker SJ, Bilo HJ. Chromium treatment has no effect in patients with poorly controlled, insulin-treated type 2 diabetes in an obese Western population: a randomized, double-blind, placebo-controlled trial. Diabetes Care. 2006 Mar;29(3):521-5. doi: 10.2337/diacare.29.03.06.dc05-1453.'}, {'pmid': '16873787', 'type': 'BACKGROUND', 'citation': 'Martin J, Wang ZQ, Zhang XH, Wachtel D, Volaufova J, Matthews DE, Cefalu WT. Chromium picolinate supplementation attenuates body weight gain and increases insulin sensitivity in subjects with type 2 diabetes. Diabetes Care. 2006 Aug;29(8):1826-32. doi: 10.2337/dc06-0254.'}, {'pmid': '12550067', 'type': 'BACKGROUND', 'citation': 'Ghosh D, Bhattacharya B, Mukherjee B, Manna B, Sinha M, Chowdhury J, Chowdhury S. Role of chromium supplementation in Indians with type 2 diabetes mellitus. J Nutr Biochem. 2002 Nov;13(11):690-697. doi: 10.1016/s0955-2863(02)00220-6.'}], 'seeAlsoLinks': [{'url': 'http://www.diabetes.org/', 'label': 'American Diabetes Association'}]}, 'descriptionModule': {'briefSummary': 'The role of micronutrients in diabetes is not well understood. Studies have demonstrated the relationship between low chromium serum levels and insulin resistance. This study aims to evaluate the effect of chromium nicotinate on increasing insulin sensitivity in patients with type 2 diabetes.', 'detailedDescription': 'Insulin is a hormone secreted by cells β of pancreatic islets in response to increased levels of glucose and serum amino acids. Insulin resistance means a decrease in the ability of insulin to stimulate glucose utilization because is disabled in the insulin receptor, decrease in concentration of receptors or failure mechanism of cell transit. Recently, the discovery of a substance called low molecular weight chromium-binding substance (LMWCr), showed the ability of this substance in amplifying insulin signaling, increasing the sensitivity of insulin receptors in the plasma membrane. This way, the capacity of LMWCr in activating the insulin receptor depends on levels of serum chromium. Thus, the hypothesis that the nutritional status of individual poor chromium contributes to the decrease in glucose tolerance and consequently, for type 2 Diabetes. Thus, it becomes necessary to assess the effect of supplementation of chromium in increased insulin sensitivity in patients with type 2 Diabetes. This is a double-blind randomized clinical trial, consisting of a period of three months of nutritional intervention with chromium nicotinate, biochemical and anthropometric evaluation and assessment of food profile and physical activity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes\n* Body mass index \\> 25 kg/m2\n* Increased waist circumference\n\nExclusion Criteria:\n\n* Subjects on insulin\n* Pregnancy\n* Patients with chronic complications as heart disease, nephropathy, retinopathy'}, 'identificationModule': {'nctId': 'NCT01368328', 'briefTitle': 'Effect of the Chromium Nicotinate on Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Federal de Goias'}, 'officialTitle': 'Effect of Chromium Supplementation on Insulin Sensitivity in Patients With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'DM2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Dietary Supplement: Chromium nicotinate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Chromium nicotinate 50 mcg', 'interventionNames': ['Dietary Supplement: Chromium nicotinate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Chromium nicotinate 200 mcg', 'interventionNames': ['Dietary Supplement: Chromium nicotinate']}], 'interventions': [{'name': 'Chromium nicotinate', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The intervention is offered during three months. There is a placebo group, chromium nicotinate 50 mcg group and chromium nicotinate 200 mcg group. Each patient is oriented to consume one capsule one hour after lunch and one capsule one hour after dinner.', 'armGroupLabels': ['Chromium nicotinate 200 mcg', 'Chromium nicotinate 50 mcg', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '74000000', 'city': 'Goiânia', 'state': 'Goiás', 'country': 'Brazil', 'facility': 'Goiania Municipal Health Departament', 'geoPoint': {'lat': -16.67861, 'lon': -49.25389}}], 'overallOfficials': [{'name': 'Marília Mendonça Guimarães', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculdade de Nutrição - Universidade Federal de Goiás'}, {'name': 'Maria Sebastiana Silva', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculdade de Educação Física - Universidade Federal de Goiás'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Federal de Goias', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Marília Mendonça Guimarães', 'oldOrganization': 'Faculdade de Nutrição Universidade Federal de Goiás'}}}}