Ignite Creation Date:
2025-12-24 @ 5:02 PM
Ignite Modification Date:
2025-12-29 @ 7:15 AM
Study NCT ID:
NCT01456650
Status:
COMPLETED
Last Update Posted:
2014-01-15
First Post:
2011-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
R230C and C230C Variants of ABCA1 and Glyburide Response
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005905', 'term': 'Glyburide'}], 'ancestors': [{'id': 'D013453', 'term': 'Sulfonylurea Compounds'}, {'id': 'D014508', 'term': 'Urea'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 85}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-14', 'studyFirstSubmitDate': '2011-10-19', 'studyFirstSubmitQcDate': '2011-10-20', 'lastUpdatePostDateStruct': {'date': '2014-01-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in plasma fasting glucose', 'timeFrame': '20 weeks', 'description': 'The effects of the alleles under study on the glucose lowering effect of glyburide will be assessed in 20 week study. Diet and exercise will be controlled per protocol'}], 'secondaryOutcomes': [{'measure': 'HbA1c levels', 'timeFrame': '20 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Type 2 diabetes', 'ABCA1 alleles', 'Glyburide'], 'conditions': ['Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '23273975', 'type': 'DERIVED', 'citation': 'Aguilar-Salinas CA, Munoz-Hernandez LL, Cobos-Bonilla M, Ramirez-Marquez MR, Ordonez-Sanchez ML, Mehta R, Medina-Santillan R, Tusie-Luna MT. The R230C variant of the ATP binding cassette protein A1 (ABCA1) gene is associated with a decreased response to glyburide therapy in patients with type 2 diabetes mellitus. Metabolism. 2013 May;62(5):638-41. doi: 10.1016/j.metabol.2012.11.006. Epub 2012 Dec 27.'}]}, 'descriptionModule': {'briefSummary': 'The objective of the study is to know if the R230C and C230C variants of the ATP-binding cassette transporter A1 (ABCA1) gene are associated with a smaller glucose lowering effect compared to the wild type allele (R230R) in patients with type 2 diabetes.', 'detailedDescription': 'Specific objectives:\n\n1. In patients with type 2 diabetes stratified by the existence of the risk alleles (R230C/C230C) or the wild variant (R230R) of ABC-A1, compare the changes resulting from the treatment with glibenclamide on following continuous variables:\n\n * Fasting glucose\n * Percentage reduction\n * Hemoglobin A1c,\n * Cholesterol, triglycerides, HDL cholesterol, LDL cholesterol\n * Weight\n2. In patients with type 2 diabetes stratified by the existence of the risk alleles (R230C/C230C) or the wild variant (R230R) of ABC-A1, compare the changes resulting from the treatment with glibenclamide on following binomial variables:\n\n * Number of cases that reach fasting plasma glucose lower than 110 mg/dl\n * Number of cases that reach an HbA1c less than 7%'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults 20 to 79 years\n* Body mass index \\>18 and 39.9 ≤\n* Men or women\n* Mexicans mestizos.\n* Moderate hyperglycemia (126 to 250 mg/dl and HbA1c levels between 7 and 10%) despite being treated with a dietary program in combination or not with metformin (2 g/d).\n\nExclusion Criteria:\n\n* Patients with chronic complications of diabetes: ischemic heart disease, stroke, proliferative retinopathy or blindness, albuminuria, chronic diarrhea, gastroparesis, non-traumatic amputation of lower limbs.\n* Patients with any monogenic syndrome, obesity, diabetes or hypoalphalipoproteinemia\n* Patients with acquired diseases that produce secondarily obesity or diabetes.\n* Treatment with anorexigenics or accelerate weight loss at the time of the selection.\n* Cardiovascular event in the 6 months prior to study entry.\n* Steroids, chemotherapy, immunosuppressive or radiotherapy.\n* Infections or concurrent acute diseases.\n* Catabolic diseases such as cancer or AIDS\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT01456650', 'briefTitle': 'R230C and C230C Variants of ABCA1 and Glyburide Response', 'organization': {'class': 'OTHER', 'fullName': 'Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran'}, 'officialTitle': 'Effect of the R230C Variant of the ATP-binding Cassette Transporter A1 (ABCA1) Gene on the Response to Treatment With Glibenclamide in Patients With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'INNSZ-ABCA1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Glyburide', 'description': 'Patients in which the fasting glucose persisted above the treatment goal (fasting glucose \\<126 mg/dl) after a 4 week diet period will receive glyburide. The dose of the medication will be adjusted based on the results of fasting glucose values. At each visit patients will return the leftover tablets; counts of the tablets will be the method for measuring the adherence to treatment. The medical study participants who decided to doses of glibenclamide will not know the allele of ABCA1 gene under study.', 'interventionNames': ['Drug: Glyburide']}], 'interventions': [{'name': 'Glyburide', 'type': 'DRUG', 'description': 'Patients in which the fasting glucose persisted above the treatment goal ( fasting plasma glucose above 126 mg/dl) will receive glyburide. The dose of the medication will be adjusted based on the result of blood glucose using the following table:\n\nFasting glucose 126 to 140 mg/dl: 2.5 mg/day (half tablet in the morning) 141 to 180 mg/dl: 5 mg/day (a tablet in the morning) 181 220 mg/dl: 7.5 mg/day (a tablet in the morning and half tablet per night) 221 to 250 mg/dl: 10 mg/day (a tablet in the morning) and a tablet in the evening.', 'armGroupLabels': ['Glyburide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14000', 'city': 'Mexico City', 'state': 'Mexico City', 'country': 'Mexico', 'facility': 'Instituto Nacional de Ciencias Medicas y Nutricion', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}], 'overallOfficials': [{'name': 'Carlos A Aguilar-Salinas, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto Nacional de Ciencias Medicas y Nutricion'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice Head of the Department of Endocrinology and Metabolism', 'investigatorFullName': 'Carlos Aguilar', 'investigatorAffiliation': 'Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran'}}}}