Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 10:57 PM
Study NCT ID:
NCT00770367
Status:
COMPLETED
Last Update Posted:
2018-08-31
First Post:
2008-10-09
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Pioglitazone and Serum Asymmetric Dimethylarginine (ADMA) in Patients With Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077205', 'term': 'Pioglitazone'}], 'ancestors': [{'id': 'D045162', 'term': 'Thiazolidinediones'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kingde@musc.edu', 'phone': '843-792-8112', 'title': 'Dana King MD', 'organization': 'Medical University of South Carolina'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Pioglitazone', 'description': 'This is the analysis period during which participants took Pioglitazone.', 'otherNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'The analysis period during which participant took the placebo.', 'otherNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Asymmetric Dimethylarginine (ADMA) Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pioglitazone', 'description': 'This is the analysis period during which participants took Pioglitazone.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'The analysis period during which participant took the placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '.80', 'groupId': 'OG000', 'lowerLimit': '.75', 'upperLimit': '.85'}, {'value': '.75', 'groupId': 'OG001', 'lowerLimit': '.71', 'upperLimit': '.79'}]}]}], 'analyses': [{'pValue': '.37', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '.05', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '.05', 'groupDescription': 'A twosample comparison of mean treatment differences conducted using a pre-determined significance level of alpha level \\<0.05. 2 a comparison of means for NOx levels at 12 weeks b/w groups. 3 on the change F2-isoprostanes at 12 weeks b/w groups.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Equivalence.'}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'Labs measured micro moles per liter of ADMA levels in participants.', 'unitOfMeasure': 'umol/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Recruited 36 participants per randomization.1st analysis is serum Asymmetric Dimethylarginine ADMA at 12 weeks b/w groups.'}, {'type': 'SECONDARY', 'title': 'NOx f2-isoprostanes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pioglitazone Then Placebo', 'description': '18 volunteers that are Diabetic adults, 40-75 years that have higher ADMA levels as well as increased inflammation will take Pioglitazone for the first 12 week period of the study and then take the placebo for the final 12 weeks of the study.\n\nPioglitazone then Placebo: Subjects will take the pioglitazone 30mg tablet daily for 3 months. This will be followed by a 4-week period during which subjects will not be taking either the study drug or placebo. During the final 12-week period the group will take a placebo.'}, {'id': 'OG001', 'title': 'Placebo Then Pioglitazone', 'description': '18 (other half of participants) volunteers that are Diabetic adults, 40-75 years that have higher ADMA levels as well as increased inflammation will take the placebo for the first 12 week period of the study and then take the Pioglitazone for the final 12 weeks of the study.\n\nPlacebo then Pioglitazone: Subjects will take the placebo for the first 12 weeks of the study. This will be followed by a 4-week period during which subjects will not be taking either the study drug or placebo. During the final 12-week period the group will take the pioglitazone 30mg tablet daily for 3 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.4', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '-1', 'spread': '2.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'Measured oxidative stress - NOx measured by chemiluminescence detection using the Sievers NOA 280i and f2-isoprostanes are isolated by thin layer chromatography and subjected to a highly sensitive and specific gas chromatography/mass spectroscopy method to measusre the oxidative stress', 'unitOfMeasure': 'Oxidative stress', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '36 adults with diabetes enrolled in the study, and 31 completed the 7-month protocol. Adherence with medication was 93% during the trial according to pill counts at the final visit. Participants were allowed to take their other regular medications during the trial.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pioglitazone', 'description': 'This is the analysis period during which participants took Pioglitazone.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'The analysis period during which participant took the placebo.'}], 'periods': [{'title': 'First Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}, {'title': 'Washout Period of 4 Weeks', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Second Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'medical clinic, 36 participants recruited', 'preAssignmentDetails': 'After informed consent, a laboratory specimen will be obtained at the visit, including a pregnancy test (if indicated), and the screening ADMA level. This information will be used to determine study eligibility. Screened participants will be eligible if their ADMA \\> 0.50 μM/L. If not eligible would be excluded from study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Pioglitazone', 'description': 'This is the analysis period during which participants took Pioglitazone.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'The analysis period during which participant took the placebo.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.2', 'spread': '1.89', 'groupId': 'BG000'}, {'value': '55.7', 'spread': '2.42', 'groupId': 'BG001'}, {'value': '54', 'spread': '1.56', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-01', 'studyFirstSubmitDate': '2008-10-09', 'resultsFirstSubmitDate': '2010-07-08', 'studyFirstSubmitQcDate': '2008-10-09', 'lastUpdatePostDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2010-10-21', 'studyFirstPostDateStruct': {'date': '2008-10-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Asymmetric Dimethylarginine (ADMA) Level', 'timeFrame': '3 months', 'description': 'Labs measured micro moles per liter of ADMA levels in participants.'}], 'secondaryOutcomes': [{'measure': 'NOx f2-isoprostanes', 'timeFrame': '3 months', 'description': 'Measured oxidative stress - NOx measured by chemiluminescence detection using the Sievers NOA 280i and f2-isoprostanes are isolated by thin layer chromatography and subjected to a highly sensitive and specific gas chromatography/mass spectroscopy method to measusre the oxidative stress'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cardiovascular risk', 'biological markers'], 'conditions': ['Diabetes']}, 'descriptionModule': {'briefSummary': 'SPECIFIC AIMS\n\n1. To determine whether pioglitazone will reduce levels of asymmetric dimethylarginine(ADMA) in patients with diabetes.\n2. To determine whether nitric oxide(NOx) products are increased with pioglitazone treatment.\n3. To determine whether pioglitazone reduces oxidative stress (F2-isoprostanes).', 'detailedDescription': 'The primary purpose of this study is to determine whether treatment with pioglitazone can reduce serum levels of asymmetric dimethylarginine (ADMA) in patients with adult diabetes. Recent research has found that elevated serum ADMA is associated with increased cardiovascular events and mortality, particularly in people with diabetes (Boger 2005, Zoccali 2006, Ueda 2007). ADMA, by mediating nitric oxide (NO) availability, may trigger pro-atherogenic effects. High plasma concentration of this substance has been associated with intima-media thickening, left ventricular hypertrophy and all-cause and cardiovascular mortality in patients with end-stage renal disease, and associated with increased cardiovascular events in patients with diabetes (Kryzazanowska 2007). The result of higher levels of ADMA and reduced output of NO increases vasoconstriction, increases inflammation, and interferes with endothelial function. Preliminary studies indicate that pioglitazone may reduce ADMA levels, and thus lower cardiovascular risk.Thus, this protocol will test whether pioglitazone can reduce ADMA levels in adult patients with diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults age 40--75 years-of-age, non-pregnant\n* Informed consent\n* History of type 2 Diabetes Mellitus\n* Stable weight for the last 3 months (no change greater than +5% of body weight)\n* ADMA \\> 0.50 µM/L (mean of non-diabetic reference group) (Devangelio 2007)\n* On stable medical therapy for at least 3 months\n* A working telephone\n\nExclusion Criteria:\n\n* Any history of known coronary heart disease, including a history of congestive heart failure, myocardial infarction, coronary re-vascularization, or stroke\n* Pregnancy\n* Chronic kidney disease, serum creatinine \\>2.0mg/dl, chronic liver disease, or uncontrolled hypertension (\\>160/100).\n* Current participation in a formal weight loss program or planning to start such a program during the next 3 months\n* Collagen vascular disease, infection, or other inflammatory condition\n* Electrocardiogram (EKG) evidence of ischemia or infarction\n* Macular edema (swelling of the back of the eye), recent excessive weight gain (over 5% of weight in 30 days), elevated liver function tests \\> 2.5 X the upper limit, or history of osteoporosis'}, 'identificationModule': {'nctId': 'NCT00770367', 'briefTitle': 'Pioglitazone and Serum Asymmetric Dimethylarginine (ADMA) in Patients With Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of South Carolina'}, 'officialTitle': 'Pioglitazone and Serum Asymmetric Dimethylarginine (ADMA) in Patients With Diabetes', 'orgStudyIdInfo': {'id': 'Takeda 07-060'}, 'secondaryIdInfos': [{'id': '18379', 'type': 'OTHER', 'domain': 'IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pioglitazone then Placebo', 'description': '18 volunteers that are Diabetic adults, 40-75 years that have higher ADMA levels as well as increased inflammation will take Pioglitazone for the first 12 week period of the study and then take the placebo for the final 12 weeks of the study.', 'interventionNames': ['Drug: Pioglitazone then Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo then Pioglitazone', 'description': '18 (other half of participants) volunteers that are Diabetic adults, 40-75 years that have higher ADMA levels as well as increased inflammation will take the placebo for the first 12 week period of the study and then take the Pioglitazone for the final 12 weeks of the study.', 'interventionNames': ['Drug: Placebo then Pioglitazone']}], 'interventions': [{'name': 'Pioglitazone then Placebo', 'type': 'DRUG', 'otherNames': ['Actos, Glustin, Zactos'], 'description': 'Subjects will take the pioglitazone 30mg tablet daily for 3 months. This will be followed by a 4-week period during which subjects will not be taking either the study drug or placebo. During the final 12-week period the group will take a placebo.', 'armGroupLabels': ['Pioglitazone then Placebo']}, {'name': 'Placebo then Pioglitazone', 'type': 'DRUG', 'otherNames': ['Actos, Glustin, Zactos'], 'description': 'Subjects will take the placebo for the first 12 weeks of the study. This will be followed by a 4-week period during which subjects will not be taking either the study drug or placebo. During the final 12-week period the group will take the pioglitazone 30mg tablet daily for 3 months.', 'armGroupLabels': ['Placebo then Pioglitazone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Department of Family Medicine, MUSC', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}], 'overallOfficials': [{'name': 'Dana E King, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of South Carolina'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of South Carolina', 'class': 'OTHER'}, 'collaborators': [{'name': 'Takeda Pharmaceuticals North America, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}