Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2026-02-24 @ 5:51 AM
Study NCT ID:
NCT01873859
Status:
COMPLETED
Last Update Posted:
2014-06-16
First Post:
2013-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety of Continuing Metformin in Diabetic Patients With Normal Kidney Function Receiving Contrast Media
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D000140', 'term': 'Acidosis, Lactic'}], 'ancestors': [{'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': 'D000138', 'term': 'Acidosis'}, {'id': 'D000137', 'term': 'Acid-Base Imbalance'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 's_alipour@sbmu.ac.ir', 'phone': '+9821 2208 3106', 'title': 'Dr. Saeed Alipour Parsa, director of clinical trial', 'organization': 'Cardiovascular research center, Shahid Beheshti University of Medical Sciences'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': "unable to follow patient's creatinine and acidosis for more than 48 hr."}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'On-metformin', 'description': 'Diabetic patients receiving contrast media without discontinuing metformin.\n\nMetformin: Incidence of lactic acidosis in diabetic patients receiving contrast media in the presence of metformin.', 'otherNumAtRisk': 83, 'otherNumAffected': 0, 'seriousNumAtRisk': 83, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Off-metformin', 'description': 'Diabetic patients receiving contrast media with discontinuation of metformin.', 'otherNumAtRisk': 79, 'otherNumAffected': 0, 'seriousNumAtRisk': 79, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of Lactic Acidosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'On-metformin', 'description': 'Diabetic patients receiving contrast media without discontinuing metformin.\n\nMetformin: Incidence of lactic acidosis in diabetic patients receiving contrast media in the presence of metformin.'}, {'id': 'OG001', 'title': 'Off-metformin', 'description': 'Diabetic patients receiving contrast media with discontinuation of metformin.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '48 hrs', 'description': 'Metformin-associated lactic acidosis (MALA) was defined as an arterial pH \\<7.35 and plasma lactate concentration \\>5 mmol ⁄ L.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change of Baseline Creatinine 48 hr After Recieving Contrast Media in the Presence or Absence of Metformin Use.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'On-metformin', 'description': 'Diabetic patients receiving contrast media without discontinuing metformin.\n\nMetformin: rise of creatinin 48 hr after recieving contrast media.'}, {'id': 'OG001', 'title': 'Off-metformin', 'description': 'Diabetic patients receiving contrast media with discontinuation of metformin.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.05', 'spread': '0.116', 'groupId': 'OG000'}, {'value': '0.99', 'spread': '0.159', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 hours from the baseline', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'On-metformin', 'description': 'Diabetic patients receiving contrast media without discontinuing metformin.\n\nMetformin: Incidence of lactic acidosis in diabetic patients receiving contrast media in the presence of metformin.'}, {'id': 'FG001', 'title': 'Off-metformin', 'description': 'Diabetic patients receiving contrast media with discontinuation of metformin.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '83'}, {'groupId': 'FG001', 'numSubjects': '83'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '83'}, {'groupId': 'FG001', 'numSubjects': '79'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '162', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'On-metformin', 'description': 'Diabetic patients receiving contrast media without discontinuing metformin.\n\nMetformin: Incidence of lactic acidosis in diabetic patients receiving contrast media in the presence of metformin.'}, {'id': 'BG001', 'title': 'Off-metformin', 'description': 'Diabetic patients receiving contrast media with discontinuation of metformin.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.57', 'groupId': 'BG000', 'lowerLimit': '41', 'upperLimit': '84'}, {'value': '60.1', 'groupId': 'BG001', 'lowerLimit': '41', 'upperLimit': '76'}, {'value': '60.9', 'groupId': 'BG002', 'lowerLimit': '41', 'upperLimit': '84'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': '166 metformin consumping patients were enrolled. Patients were randomly allocated to continue metformin during peri-angiography period or to stop the medication 24 hours prior the procedure. Four patients in the M (-) group did not complete the study protocol and were excluded from the study.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 166}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-16', 'studyFirstSubmitDate': '2013-06-05', 'resultsFirstSubmitDate': '2014-03-31', 'studyFirstSubmitQcDate': '2013-06-07', 'lastUpdatePostDateStruct': {'date': '2014-06-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-05-16', 'studyFirstPostDateStruct': {'date': '2013-06-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-06-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Lactic Acidosis', 'timeFrame': '48 hrs', 'description': 'Metformin-associated lactic acidosis (MALA) was defined as an arterial pH \\<7.35 and plasma lactate concentration \\>5 mmol ⁄ L.'}, {'measure': 'Change of Baseline Creatinine 48 hr After Recieving Contrast Media in the Presence or Absence of Metformin Use.', 'timeFrame': '48 hours from the baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Lactic acidosis', 'Contrast media', 'Angiography', 'Diabetic', 'Metformin'], 'conditions': ['Diabetes Mellitus', 'Lactic Acidosis']}, 'referencesModule': {'references': [{'pmid': '20032157', 'type': 'BACKGROUND', 'citation': 'Goergen SK, Rumbold G, Compton G, Harris C. Systematic review of current guidelines, and their evidence base, on risk of lactic acidosis after administration of contrast medium for patients receiving metformin. Radiology. 2010 Jan;254(1):261-9. doi: 10.1148/radiol.09090690.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether metformin causes lactic acidosis in diabetic patients with preserved kidney function, undergoing coronary angiography or angioplasty with new contrast media.\n\nIn other words is it necessary to discontinue metformin before these procedures, even when Iodixanol is used as contrast media, which is isosmolar agent and much more safer than urografin which was the main agent in the previous studies that were the base of present guidelines?', 'detailedDescription': 'Although metformin is not directly nephrotoxic, it has been postulated that can impair gluconeogenesis from lactate, which may lead to lactate accumulation under circumstances such as acute renal failure. In diabetic patients receiving metformin, this condition can be encountered in the setting of acute renal failure following contrast media administration, during coronary angiography i.e. contrast-induced nephropathy. As a result, it has been a part of routine clinical practice to discontinue metformin before angiography to prevent metformin-associated lactic acidosis (MALA). However, there is no general consensus regarding the incidence of MALA and evidence for such intervention is poor. On the other hand, discontinuation of metformin can be associated with detrimental effects on glycemic control and thereby may increase cardiovascular risk in diabetic patients undergoing percutaneous coronary interventions. Consequently, questions have been raised recently regarding the routine discontinuation of metformin, in low-risk patients undergoing coronary angiography.\n\nThe present study was designed to assess the role of metformin in lactate production in a group of diabetic patients with normal renal function; and to address the questions about significance of routine discontinuation of metformin in low risk patients undergoing coronary angiography.\n\nIodixanol will be the only contrast media in all patients, because of its low nephrotoxicity. Serum blood urea nitrogen and creatinin; as well as arterial blood gases will be evaluated prior to angiography, and repeated 24 and 48 hours after the procedure. Glomerular filtration rate (GFR) is calculated using Cockcroft-Gault formula {GFR= 0.85 (for women)}.\n\nContrast-induced acute kidney injury is defined as a 25-50% or 0.3-0.5 mg/dl net increase in creatinine concentration compared to the baseline values. Metformin-associated lactic acidosis (MALA) is defined as an arterial pH (potential of hydrogen)\\<7.35 and plasma lactate concentration \\>5 mmol⁄L. In the M (-) group metformin will re-started 48 hours after angiography, albeit in the absence of evidence of lactic acidosis and GFR of \\>60 mL/min per 1.73 m2.\n\nA written informed consent is taken from all participants and institutional review board has already approved the trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diabetic patients receiving metformin who were scheduled for:\n\n * coronary angiography\n * coronary angioplasty\n\nExclusion Criteria:\n\n* Patients who had contraindication for metformin administration, such as:\n\n * decompensated heart failure\n * severe liver disease\n * severe hypoxemia\n * GFR\\<60 mL/min per 1.73 m2'}, 'identificationModule': {'nctId': 'NCT01873859', 'briefTitle': 'Safety of Continuing Metformin in Diabetic Patients With Normal Kidney Function Receiving Contrast Media', 'organization': {'class': 'OTHER', 'fullName': 'Shahid Beheshti University of Medical Sciences'}, 'officialTitle': 'Incidence of Lactic Acidosis After Coronary Angiography and Angioplasty in Diabetic Patients on Continued Metformin Therapy With Normal Renal Function.', 'orgStudyIdInfo': {'id': 'sbcvrc-43-891128'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'On-metformin', 'description': 'Diabetic patients receiving contrast media without discontinuing metformin.', 'interventionNames': ['Drug: Metformin']}, {'type': 'NO_INTERVENTION', 'label': 'Off-metformin', 'description': 'Diabetic patients receiving contrast media with discontinuation of metformin.'}], 'interventions': [{'name': 'Metformin', 'type': 'DRUG', 'otherNames': ['Glucophage'], 'description': 'Incidence of lactic acidosis in diabetic patients receiving contrast media in the presence of metformin.', 'armGroupLabels': ['On-metformin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tehran', 'state': 'Tehran Province', 'country': 'Iran', 'facility': 'Cardiovascular research center, Modarres hospital.', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'overallOfficials': [{'name': 'Saeed Alipour Parsa', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cardiovascular research center, Modarres hospital, Shahid Beheshti University of Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shahid Beheshti University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Alipour Parsa S., Assistant professor of cardiology, Cardiovascular Research Center, Modarres hospital', 'investigatorFullName': 'Saeed Alipour Parsa', 'investigatorAffiliation': 'Shahid Beheshti University of Medical Sciences'}}}}