Ignite Creation Date:
2025-12-24 @ 4:43 PM
Ignite Modification Date:
2025-12-27 @ 3:54 AM
Study NCT ID:
NCT00105066
Status:
COMPLETED
Last Update Posted:
2017-01-18
First Post:
2005-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Effects of Metformin on Blood Vessel Structure and Function
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D006937', 'term': 'Hypercholesterolemia'}, {'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}, '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': 'straitj@mail.nih.gov', 'phone': '4105588084', 'title': 'Dr. James Strait', 'organization': 'National Institute On Aging'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo : placebo tablet once a day for one month, then twice a day for 3 months', 'otherNumAtRisk': 27, 'otherNumAffected': 1, 'seriousNumAtRisk': 27, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Metformin', 'description': 'Metformin : 850mg tablet once a day for one month, then twice a day for 3 months', 'otherNumAtRisk': 50, 'otherNumAffected': 6, 'seriousNumAtRisk': 50, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Arterial Stiffness Compared to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo : placebo tablet once a day for one month, then twice a day for 3 months'}, {'id': 'OG001', 'title': 'Metformin', 'description': 'Metformin : 850mg tablet once a day for one month, then twice a day for 3 months'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.2', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '-7.3', 'spread': '1.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 4.5 months', 'unitOfMeasure': 'meters / second', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Flow Mediated Dilation (FMD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo : placebo tablet once a day for one month, then twice a day for 3 months'}, {'id': 'OG001', 'title': 'Metformin', 'description': 'Metformin : 850mg tablet once a day for one month, then twice a day for 3 months'}], 'classes': [{'categories': [{'measurements': [{'value': '8.8', 'spread': '7.0', 'groupId': 'OG000'}, {'value': '10.5', 'spread': '8.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 4.5 months', 'description': 'to evaluate improvement in endothelial function', 'unitOfMeasure': 'percentage change in diameter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with complete data.'}, {'type': 'POST_HOC', 'title': 'Homa Insulin Sensitivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo : placebo tablet once a day for one month, then twice a day for 3 months'}, {'id': 'OG001', 'title': 'Metformin', 'description': 'Metformin : 850mg tablet once a day for one month, then twice a day for 3 months'}], 'classes': [{'categories': [{'measurements': [{'value': '57.4', 'spread': '36.3', 'groupId': 'OG000'}, {'value': '64.5', 'spread': '27.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4.5 months', 'description': 'Homeostatic Model Assessment of insulin sensitivity', 'unitOfMeasure': 'HOMA Score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with complete data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo : placebo tablet once a day for one month, then twice a day for 3 months'}, {'id': 'FG001', 'title': 'Metformin', 'description': 'Metformin : 850mg tablet once a day for one month, then twice a day for 3 months'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '45'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo : placebo tablet once a day for one month, then twice a day for 3 months'}, {'id': 'BG001', 'title': 'Metformin', 'description': 'Metformin : 850mg tablet once a day for one month, then twice a day for 3 months'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.6', 'spread': '13.5', 'groupId': 'BG000'}, {'value': '55.1', 'spread': '11.8', 'groupId': 'BG001'}, {'value': '54.4', 'spread': '12.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Carotid Femoral Pulse Wave Velocity', 'classes': [{'categories': [{'measurements': [{'value': '6.8', 'spread': '2.1', 'groupId': 'BG000'}, {'value': '6.8', 'spread': '2.1', 'groupId': 'BG001'}, {'value': '6.8', 'spread': '2.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'meters/second', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'FMD', 'classes': [{'categories': [{'measurements': [{'value': '7.6', 'spread': '4.4', 'groupId': 'BG000'}, {'value': '9.3', 'spread': '6.1', 'groupId': 'BG001'}, {'value': '8.5', 'spread': '5.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Flow Mediated Dilation of brachial artery (percent change in blood flow after hyperemia)', 'unitOfMeasure': 'percentage', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'HOMA-S', 'classes': [{'categories': [{'measurements': [{'value': '52.9', 'spread': '26.9', 'groupId': 'BG000'}, {'value': '52.3', 'spread': '23.1', 'groupId': 'BG001'}, {'value': '52.5', 'spread': '24.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'HOMA Insulin Sensitivity Index', 'unitOfMeasure': 'HOMA Score', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 77}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-12', 'studyFirstSubmitDate': '2005-03-03', 'resultsFirstSubmitDate': '2013-04-25', 'studyFirstSubmitQcDate': '2005-03-03', 'lastUpdatePostDateStruct': {'date': '2017-01-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2017-01-12', 'studyFirstPostDateStruct': {'date': '2005-03-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-01-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Arterial Stiffness Compared to Baseline', 'timeFrame': 'Baseline and 4.5 months'}, {'measure': 'Change in Flow Mediated Dilation (FMD)', 'timeFrame': 'Baseline and 4.5 months', 'description': 'to evaluate improvement in endothelial function'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Metabolic Syndrome', 'triglycerides', 'HDL', 'LDL', 'High Blood Pressure', 'High Cholesterol', 'High Blood Sugar'], 'conditions': ['Obesity', 'Hypertension', 'Hypercholesterolemia', 'Hyperglycemia']}, 'referencesModule': {'references': [{'pmid': '11832527', 'type': 'BACKGROUND', 'citation': 'Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403. doi: 10.1056/NEJMoa012512.'}, {'pmid': '9892243', 'type': 'BACKGROUND', 'citation': 'Beisswenger PJ, Howell SK, Touchette AD, Lal S, Szwergold BS. Metformin reduces systemic methylglyoxal levels in type 2 diabetes. Diabetes. 1999 Jan;48(1):198-202. doi: 10.2337/diabetes.48.1.198.'}, {'pmid': '11300445', 'type': 'BACKGROUND', 'citation': 'Mather KJ, Verma S, Anderson TJ. Improved endothelial function with metformin in type 2 diabetes mellitus. J Am Coll Cardiol. 2001 Apr;37(5):1344-50. doi: 10.1016/s0735-1097(01)01129-9.'}, {'pmid': '9742977', 'type': 'BACKGROUND', 'citation': 'Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34). UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998 Sep 12;352(9131):854-65.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate whether the drug Metformin has beneficial effects on the blood vessels of individuals with the Metabolic Syndrome (MeS).', 'detailedDescription': 'Individuals with the Metabolic Syndrome (MeS) are at increased risk for developing cardiovascular diseases. This increased risk may, in part, be related to abnormalities in the blood vessels. MeS is defined as having 3 or more of the following 5 criteria:\n\n* Abdominal obesity (waist measurement \\>39.8 inches in men, \\>34.4 inches in women)\n* Elevated triglycerides (\\>150 mg/dl)\n* Low HDL or "good" cholesterol (\\<40 mg/dl in men or \\<50 mg/dl in women)\n* Elevated blood pressure (\\>130/85) or treatment for high blood pressure\n* Elevated fasting blood sugar (\\>100 mg/dl)\n\nMetformin is a medication that is approved by the Food and Drug Administration (FDA) for the treatment of diabetes; however, it can also be safely administered to non-diabetic subjects. We are evaluating whether Metformin reduces the stiffness of blood vessels and improves endothelial function.\n\nThis study requires 4 visits to the NIA Clinical Research Center (located on the premises of Harbor Hospital) over a 5-month period. At the initial visit, patients will be given a physical examination with blood and urine tests, and an EKG. They will be randomized into one of two groups; one group will receive Metformin (1700 mg per day), while the other group will receive a placebo. Participants will take the medication for 4 months. Subsequent visits will include additional blood tests, ultrasound and echo exams.\n\nTaking part in this study is entirely voluntary. All testing and medications will be provided at no cost to the participant or their family.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nParticipants with the Metabolic Syndrome, which is defined as having 3 or more of the following 5 alterations:\n\n* Abdominal obesity (waist measurement \\>39.8 inches in men, \\>34.4 inches in women)\n* Elevated triglycerides (\\>150 mg/dl)\n* Low HDL or "good" cholesterol (\\<40 mg/dl in men or \\<50 mg/dl in women)\n* Elevated blood pressure (\\>130/85) or treatment for high blood pressure\n* Elevated fasting blood sugar (\\>100 mg/dl)\n\nExclusion Criteria:\n\n* Diabetes treated with medication\n* Blood pressure \\>160/100 mmHg\n* Clinical Congestive Heart Failure\n* Anemia with hematocrit \\<32%\n* Asthma or Chronic Obstructive Pulmonary Disease (COPD) requiring daily medication or use of home oxygen therapy\n* Major surgery planned within the next six months\n* A recent, unexplained weight loss of \\>10% of body weight in the past 6 months\n* A known allergy or hypersensitivity to Metformin\n* History of hepatitis or cirrhosis\n* History of kidney disease (defined as serum creatinine \\>1.4 mg/dL in men, \\>1.3 mg/dL in women)\n* Pregnancy or the absence of an effective method of contraception\n* Illicit drug or alcohol abuse\n* Cancer requiring treatment currently or recently completed treatment in the last 2 months'}, 'identificationModule': {'nctId': 'NCT00105066', 'briefTitle': 'The Effects of Metformin on Blood Vessel Structure and Function', 'organization': {'class': 'NIH', 'fullName': 'National Institutes of Health Clinical Center (CC)'}, 'officialTitle': 'The Effects of Metformin on Vascular Structure and Function in Subjects With the Metabolic Syndrome (MET Trial)', 'orgStudyIdInfo': {'id': 'AG0017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Metformin', 'description': 'Metformin 850 mg twice daily', 'interventionNames': ['Drug: Metformin']}], 'interventions': [{'name': 'Metformin', 'type': 'DRUG', 'otherNames': ['Fortamet®; Glucophage®; Glumetza™; Riomet™'], 'description': '850mg tablet once a day for one month, then twice a day for 3 months', 'armGroupLabels': ['Metformin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'placebo tablet once a day for one month, then twice a day for 3 months', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21225', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'National Institute on Aging (NIA), Harbor Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Luigi Ferrucci, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Institute on Aging (NIA)'}, {'name': 'James Strait, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Institute on Aging (NIA)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}