[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100279270":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":45,"responsibleParty":663,"collaborators":26,"id":665,"slug":666,"hasResults":667,"nctId":668,"briefTitle":669,"officialTitle":670,"acronym":671,"eligibilityCriteria":672,"healthyVolunteers":667,"sex":673,"minAge":674,"maxAge":26,"enrollmentInfo":675,"targetDuration":26,"studyType":678,"phases":679,"briefSummary":681,"conditions":682,"keywords":685,"overallStatus":48,"whyStopped":26,"lastUpdateSubmitDate":690,"lastUpdatePostDateStruct":691,"startDateStruct":694,"completionDateStruct":696,"leadSponsor":698,"locationsCount":699},{"fullName":5,"class":6},"VA Office of Research and Development","FED",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Metformin","EXPERIMENTAL","Participants receive initial treatment with metformin XR 500 mg 1 tablet daily, with stepwise titration to a maximum dose of 2000 mg (4 tablets) daily.",[13],"Drug: Metformin XR",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Participants receive initial treatment with 1 tablet daily of placebo (for metformin XR), with stepwise titration to a maximum of 4 tablets daily.",[19],"Drug: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Metformin XR","The study medication dose may be increased by a step-wise fashion up to a maximum of 4 tablets per day.",[9],null,{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"For patients \\\u003C 80 years of age at the time of a study visit, and with most recent eGFR 45 mL\u002Fmin\u002F1.73 m2, study medication dose may be increased in a stepwise fashion to a maximum of 4 tablets daily, corresponding to metformin XR 2000 mg or matching placebo.\n\nFor patients 80 years of age or with most recent 30 eGFR \\\u003C 45 mL\u002Fmin\u002F1.73 m2, the maximum dose of study medication is 2 tablets daily, corresponding to metformin XR 1000 mg or matching placebo",[15],[31],{"name":32,"affiliation":33,"role":34},"Gregory G. Schwartz, PhD MD","Rocky Mountain Regional VA Medical Center, Aurora, CO","STUDY_CHAIR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Gregory G Schwartz, PhD MD","CONTACT","(720) 723-6070","Gregory.Schwartz@va.gov",{"name":42,"role":38,"phone":43,"phoneExt":26,"email":44},"Kevin Gropp","(720) 857-5659","kevin.gropp@va.gov",[46,66,81,96,112,126,146,161,176,191,207,223,238,252,268,283,294,309,324,341,357,372,387,402,418,434,449,464,475,490,511,526,541,557,572,587,602,617,631,647],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Phoenix VA Health Care System, Phoenix, AZ","RECRUITING","Phoenix","Arizona","85012","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-112.07404,33.44838,{"lat":58,"lon":57},[61],{"name":62,"role":38,"phone":63,"phoneExt":64,"email":65},"Peter Reaven, MD","602-277-5551","6875","Peter.Reaven@va.gov",{"facility":67,"status":48,"city":68,"state":50,"zip":69,"country":52,"countryCode":53,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"Southern Arizona VA Health Care System, Tucson, AZ","Tucson","85723-0001",{"type":55,"coordinates":71},[72,73],-110.92648,32.22174,{"lat":73,"lon":72},[76],{"name":77,"role":38,"phone":78,"phoneExt":79,"email":80},"Punit Goel, MD","520-792-1450","16445","Punit.Goel@va.gov",{"facility":82,"status":48,"city":83,"state":84,"zip":85,"country":52,"countryCode":53,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"Central Arkansas VHS John L. McClellan Memorial Veterans Hospital, Little Rock, AR","Little Rock","Arkansas","72205-5484",{"type":55,"coordinates":87},[88,89],-92.28959,34.74648,{"lat":89,"lon":88},[92],{"name":93,"role":38,"phone":94,"phoneExt":26,"email":95},"Barry Uretsky, MD","501-257-5808","Barry.Uretsky@va.gov",{"facility":97,"status":48,"city":98,"state":99,"zip":100,"country":52,"countryCode":53,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"VA Loma Linda Healthcare System, Loma Linda, CA","Loma Linda","California","92357-1000",{"type":55,"coordinates":102},[103,104],-117.26115,34.04835,{"lat":104,"lon":103},[107],{"name":108,"role":38,"phone":109,"phoneExt":110,"email":111},"Geir Frivold, MD","909-825-7084","3629","Geir.frivold@va.gov",{"facility":113,"status":48,"city":114,"state":99,"zip":115,"country":52,"countryCode":53,"cosmosGeoPoint":116,"geoPoint":120,"contacts":121},"VA Long Beach Healthcare System, Long Beach, CA","Long Beach","90822",{"type":55,"coordinates":117},[118,119],-118.18923,33.76696,{"lat":119,"lon":118},[122],{"name":123,"role":38,"phone":124,"phoneExt":26,"email":125},"Anthony Vo, MD","562-826-3497","Anthony.Vo@va.gov",{"facility":127,"status":48,"city":128,"state":99,"zip":129,"country":52,"countryCode":53,"cosmosGeoPoint":130,"geoPoint":134,"contacts":135},"VA Palo Alto Health Care System, Palo Alto, CA","Palo Alto","94304-1207",{"type":55,"coordinates":131},[132,133],-122.14302,37.44188,{"lat":133,"lon":132},[136,141],{"name":137,"role":38,"phone":138,"phoneExt":139,"email":140},"Arlina Ahluwalia, MD","650-493-5000","61755","Arlina.Ahluwalia@va.gov",{"name":142,"role":38,"phone":143,"phoneExt":144,"email":145},"Paul Heidenreich, MD","6504935000","64069","Paul.Heidenreich@va.gov",{"facility":147,"status":48,"city":148,"state":99,"zip":149,"country":52,"countryCode":53,"cosmosGeoPoint":150,"geoPoint":154,"contacts":155},"VA San Diego Healthcare System, San Diego, CA","San Diego","92161-0002",{"type":55,"coordinates":151},[152,153],-117.16472,32.71571,{"lat":153,"lon":152},[156],{"name":157,"role":38,"phone":158,"phoneExt":159,"email":160},"Leda Felicio, MD","858-552-8585","2232","leda.felicio@va.gov",{"facility":162,"status":48,"city":163,"state":99,"zip":164,"country":52,"countryCode":53,"cosmosGeoPoint":165,"geoPoint":169,"contacts":170},"VA Greater Los Angeles Healthcare System, West Los Angeles, CA","West Los Angeles","90073-1003",{"type":55,"coordinates":166},[167,168],-118.43068,34.0462,{"lat":168,"lon":167},[171],{"name":172,"role":38,"phone":173,"phoneExt":174,"email":175},"Tannaz Moin, MD","310-478-3711","48380","Tannaz.Moin@va.gov; tmoin@mednet.ucla.edu",{"facility":33,"status":48,"city":177,"state":178,"zip":179,"country":52,"countryCode":53,"cosmosGeoPoint":180,"geoPoint":184,"contacts":185},"Aurora","Colorado","80045-7211",{"type":55,"coordinates":181},[182,183],-104.83192,39.72943,{"lat":183,"lon":182},[186,190],{"name":187,"role":38,"phone":188,"phoneExt":26,"email":189},"Sridharan Raghavan, MD PhD","(415) 254-3563","Sridharan.Raghavan@va.gov",{"name":32,"role":34,"phone":26,"phoneExt":26,"email":26},{"facility":192,"status":48,"city":193,"state":194,"zip":195,"country":52,"countryCode":53,"cosmosGeoPoint":196,"geoPoint":200,"contacts":201},"VA Connecticut Healthcare System West Haven Campus, West Haven, CT","West Haven","Connecticut","06516-2770",{"type":55,"coordinates":197},[198,199],-72.94705,41.27065,{"lat":199,"lon":198},[202],{"name":203,"role":38,"phone":204,"phoneExt":205,"email":206},"Brian Malm, MD","203-932-5711","2650","Brian.Malm@va.gov",{"facility":208,"status":48,"city":209,"state":210,"zip":211,"country":52,"countryCode":53,"cosmosGeoPoint":212,"geoPoint":216,"contacts":217},"Bay Pines VA Healthcare System, Pay Pines, FL","Bay Pines","Florida","33744-0000",{"type":55,"coordinates":213},[214,215],-82.77816,27.81419,{"lat":215,"lon":214},[218],{"name":219,"role":38,"phone":220,"phoneExt":221,"email":222},"Manjunath Harlapur, MD","727-398-6661","14893","Manjunath.Harlapur@va.gov",{"facility":224,"status":48,"city":225,"state":210,"zip":226,"country":52,"countryCode":53,"cosmosGeoPoint":227,"geoPoint":231,"contacts":232},"North Florida\u002FSouth Georgia Veterans Health System, Gainesville, FL","Gainesville","32608-1135",{"type":55,"coordinates":228},[229,230],-82.32483,29.65163,{"lat":230,"lon":229},[233],{"name":234,"role":38,"phone":235,"phoneExt":236,"email":237},"Carsten Schmalfuss, MD","352-376-1611","6052","Carsten.Schmalfuss@va.gov",{"facility":239,"status":48,"city":240,"state":210,"zip":241,"country":52,"countryCode":53,"cosmosGeoPoint":242,"geoPoint":246,"contacts":247},"Miami VA Healthcare System, Miami, FL","Miami","33125",{"type":55,"coordinates":243},[244,245],-80.19366,25.77427,{"lat":245,"lon":244},[248],{"name":249,"role":38,"phone":250,"phoneExt":26,"email":251},"Ana Palacio, MD","305-926-3780","Ana.Palacio@va.gov",{"facility":253,"status":48,"city":254,"state":255,"zip":256,"country":52,"countryCode":53,"cosmosGeoPoint":257,"geoPoint":261,"contacts":262},"Atlanta VA Medical and Rehab Center, Decatur, GA","Decatur","Georgia","30033-4004",{"type":55,"coordinates":258},[259,260],-84.29631,33.77483,{"lat":260,"lon":259},[263],{"name":264,"role":38,"phone":265,"phoneExt":266,"email":267},"Mary Rhee, MD","404-321-6111","202080","Mary.Rhee@va.gov",{"facility":269,"status":48,"city":270,"state":271,"zip":272,"country":52,"countryCode":53,"cosmosGeoPoint":273,"geoPoint":277,"contacts":278},"VA Pacific Islands Health Care System, Honolulu, HI","Honolulu","Hawaii","96819-1522",{"type":55,"coordinates":274},[275,276],-157.85833,21.30694,{"lat":276,"lon":275},[279],{"name":280,"role":38,"phone":281,"phoneExt":26,"email":282},"Kelsey Shikuma-Lee, MD","808-433-7643","Kelsey.ShikumaLee@va.gov",{"facility":284,"status":285,"city":286,"state":287,"zip":288,"country":52,"countryCode":53,"cosmosGeoPoint":289,"geoPoint":293,"contacts":26},"Jesse Brown VA Medical Center, Chicago, IL","TERMINATED","Chicago","Illinois","60612",{"type":55,"coordinates":290},[291,292],-87.65005,41.85003,{"lat":292,"lon":291},{"facility":295,"status":48,"city":296,"state":287,"zip":297,"country":52,"countryCode":53,"cosmosGeoPoint":298,"geoPoint":302,"contacts":303},"Edward Hines Jr. VA Hospital, Hines, IL","Hines","60141-3030",{"type":55,"coordinates":299},[300,301],-87.8395,41.85364,{"lat":301,"lon":300},[304],{"name":305,"role":38,"phone":306,"phoneExt":307,"email":308},"Amit Dayal, MD","708-202-8387","24564","Amit.Dayal@va.gov",{"facility":310,"status":48,"city":311,"state":312,"zip":313,"country":52,"countryCode":53,"cosmosGeoPoint":314,"geoPoint":318,"contacts":319},"Iowa City VA Health Care System, Iowa City, IA","Iowa City","Iowa","52246-2292",{"type":55,"coordinates":315},[316,317],-91.53017,41.66113,{"lat":317,"lon":316},[320],{"name":321,"role":38,"phone":322,"phoneExt":26,"email":323},"David Katz, MD","319-353-8622","David.Katz2@va.gov",{"facility":325,"status":326,"city":327,"state":328,"zip":329,"country":52,"countryCode":53,"cosmosGeoPoint":330,"geoPoint":334,"contacts":335},"Lexington VA Medical Center, Lexington, KY","NOT_YET_RECRUITING","Lexington","Kentucky","40502-2235",{"type":55,"coordinates":331},[332,333],-84.47772,37.98869,{"lat":333,"lon":332},[336],{"name":337,"role":38,"phone":338,"phoneExt":339,"email":340},"Dennis Karounos, MD","859-233-4511","4430","Dennis.Karounos@va.gov",{"facility":342,"status":48,"city":343,"state":344,"zip":345,"country":52,"countryCode":53,"cosmosGeoPoint":346,"geoPoint":350,"contacts":351},"Rehabilitation R&D Service, Baltimore, MD","Baltimore","Maryland","21202",{"type":55,"coordinates":347},[348,349],-76.61219,39.29038,{"lat":349,"lon":348},[352],{"name":353,"role":38,"phone":354,"phoneExt":355,"email":356},"Ilias Spanakis, MD","410-605-7000","7394","Ilias.Spanakis@va.gov",{"facility":358,"status":48,"city":359,"state":360,"zip":361,"country":52,"countryCode":53,"cosmosGeoPoint":362,"geoPoint":366,"contacts":367},"VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA","Boston","Massachusetts","02130-4817",{"type":55,"coordinates":363},[364,365],-71.05977,42.35843,{"lat":365,"lon":364},[368],{"name":369,"role":38,"phone":370,"phoneExt":26,"email":371},"Scott Kinlay, MD","857-203-6840","Scott.Kinlay@va.gov",{"facility":373,"status":48,"city":374,"state":375,"zip":376,"country":52,"countryCode":53,"cosmosGeoPoint":377,"geoPoint":381,"contacts":382},"Minneapolis VA Health Care System, Minneapolis, MN","Minneapolis","Minnesota","55417-2309",{"type":55,"coordinates":378},[379,380],-93.26384,44.97997,{"lat":380,"lon":379},[383],{"name":384,"role":38,"phone":385,"phoneExt":26,"email":386},"Selcuk Adabag, MD","612-467-3655","Selcuk.Adabag@va.gov",{"facility":388,"status":48,"city":389,"state":390,"zip":391,"country":52,"countryCode":53,"cosmosGeoPoint":392,"geoPoint":396,"contacts":397},"Kansas City VA Medical Center, Kansas City, MO","Kansas City","Missouri","64128-2226",{"type":55,"coordinates":393},[394,395],-94.57857,39.09973,{"lat":395,"lon":394},[398],{"name":399,"role":38,"phone":400,"phoneExt":26,"email":401},"Mariana Garcia-Touza, MD","914-886-3866","Mariana.Garcia-Touza@va.gov",{"facility":403,"status":48,"city":404,"state":405,"zip":406,"country":52,"countryCode":53,"cosmosGeoPoint":407,"geoPoint":411,"contacts":412},"Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE","Omaha","Nebraska","68105-1850",{"type":55,"coordinates":408},[409,410],-95.94043,41.25626,{"lat":410,"lon":409},[413],{"name":414,"role":38,"phone":415,"phoneExt":416,"email":417},"Cyrus Desouza, MD","402-346-8800","5506","cyrus.desouza@va.gov",{"facility":419,"status":48,"city":420,"state":421,"zip":422,"country":52,"countryCode":53,"cosmosGeoPoint":423,"geoPoint":427,"contacts":428},"New Mexico VA Health Care System, Albuquerque, NM","Albuquerque","New Mexico","87108-5153",{"type":55,"coordinates":424},[425,426],-106.65114,35.08449,{"lat":426,"lon":425},[429],{"name":430,"role":38,"phone":431,"phoneExt":432,"email":433},"Michelle D Ratliff, MD","505-265-1711","4495","Michelle.Ratliff@va.gov",{"facility":435,"status":48,"city":436,"state":436,"zip":437,"country":52,"countryCode":53,"cosmosGeoPoint":438,"geoPoint":442,"contacts":443},"Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY","New York","10010-5011",{"type":55,"coordinates":439},[440,441],-74.00597,40.71427,{"lat":441,"lon":440},[444],{"name":445,"role":38,"phone":446,"phoneExt":447,"email":448},"Binita Shah, MD","212-686-7500","7722","Binita.Shah@va.gov",{"facility":450,"status":48,"city":451,"state":452,"zip":453,"country":52,"countryCode":53,"cosmosGeoPoint":454,"geoPoint":458,"contacts":459},"Durham VA Medical Center, Durham, NC","Durham","North Carolina","27705-3875",{"type":55,"coordinates":455},[456,457],-78.89862,35.99403,{"lat":457,"lon":456},[460],{"name":461,"role":38,"phone":462,"phoneExt":26,"email":463},"Matthew Crowley, MD","919-599-8865","Matthew.Crowley@va.gov",{"facility":465,"status":466,"city":467,"state":468,"zip":469,"country":52,"countryCode":53,"cosmosGeoPoint":470,"geoPoint":474,"contacts":26},"Cincinnati VA Medical Center, Cincinnati, OH","ACTIVE_NOT_RECRUITING","Cincinnati","Ohio","45220-2213",{"type":55,"coordinates":471},[472,473],-84.51439,39.12711,{"lat":473,"lon":472},{"facility":476,"status":48,"city":477,"state":468,"zip":478,"country":52,"countryCode":53,"cosmosGeoPoint":479,"geoPoint":483,"contacts":484},"Louis Stokes VA Medical Center, Cleveland, OH","Cleveland","44106-1702",{"type":55,"coordinates":480},[481,482],-81.69541,41.4995,{"lat":482,"lon":481},[485],{"name":486,"role":38,"phone":487,"phoneExt":488,"email":489},"Laure Sayyed Kassem, MD","216-791-3800","65184","Laure.SayyedKassem@va.gov",{"facility":491,"status":48,"city":492,"state":493,"zip":494,"country":52,"countryCode":53,"cosmosGeoPoint":495,"geoPoint":499,"contacts":500},"VA Portland Health Care System, Portland, OR","Portland","Oregon","97207-2964",{"type":55,"coordinates":496},[497,498],-122.67621,45.52345,{"lat":498,"lon":497},[501,506],{"name":502,"role":38,"phone":503,"phoneExt":504,"email":505},"North Noelck, MD","503-220-8262","56426","North.Noelck2@va.gov",{"name":507,"role":38,"phone":508,"phoneExt":509,"email":510},"Linda Humphrey, MD","5032208262","57176","Linda.Humphrey@va.gov",{"facility":512,"status":48,"city":513,"state":514,"zip":515,"country":52,"countryCode":53,"cosmosGeoPoint":516,"geoPoint":520,"contacts":521},"Ralph H. Johnson VA Medical Center, Charleston, SC","Charleston","South Carolina","29401-5703",{"type":55,"coordinates":517},[518,519],-79.93275,32.77632,{"lat":519,"lon":518},[522],{"name":523,"role":38,"phone":524,"phoneExt":26,"email":525},"Ashley Waring, MD","843-789-6467","Ashley.Waring@va.gov",{"facility":527,"status":48,"city":528,"state":514,"zip":529,"country":52,"countryCode":53,"cosmosGeoPoint":530,"geoPoint":534,"contacts":535},"Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC","Columbia","29209-1638",{"type":55,"coordinates":531},[532,533],-81.03481,34.00071,{"lat":533,"lon":532},[536],{"name":537,"role":38,"phone":538,"phoneExt":539,"email":540},"Subhashini Yaturu, MD","803-776-4000","6092","Subhashini.Yaturu@va.gov",{"facility":542,"status":48,"city":543,"state":544,"zip":545,"country":52,"countryCode":53,"cosmosGeoPoint":546,"geoPoint":550,"contacts":551},"Memphis VA Medical Center, Memphis, TN","Memphis","Tennessee","38104-2127",{"type":55,"coordinates":547},[548,549],-90.04898,35.14953,{"lat":549,"lon":548},[552],{"name":553,"role":38,"phone":554,"phoneExt":555,"email":556},"Richard D Childress, MD","901-523-8990","6817","richard.childress@va.gov",{"facility":558,"status":48,"city":559,"state":560,"zip":561,"country":52,"countryCode":53,"cosmosGeoPoint":562,"geoPoint":566,"contacts":567},"VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX","Dallas","Texas","75216-7167",{"type":55,"coordinates":563},[564,565],-96.80667,32.78306,{"lat":565,"lon":564},[568],{"name":569,"role":38,"phone":570,"phoneExt":26,"email":571},"Colleen Sam, MD","214-857-1477","Colleen.Sam@va.gov",{"facility":573,"status":48,"city":574,"state":560,"zip":575,"country":52,"countryCode":53,"cosmosGeoPoint":576,"geoPoint":580,"contacts":581},"Michael E. DeBakey VA Medical Center, Houston, TX","Houston","77030-4211",{"type":55,"coordinates":577},[578,579],-95.36327,29.76328,{"lat":579,"lon":578},[582],{"name":583,"role":38,"phone":584,"phoneExt":585,"email":586},"Arunima Misra, MD","713-791-1414","27940","Arunima.Misra@va.gov",{"facility":588,"status":48,"city":589,"state":590,"zip":591,"country":52,"countryCode":53,"cosmosGeoPoint":592,"geoPoint":596,"contacts":597},"VA Salt Lake City Health Care System, Salt Lake City, UT","Salt Lake City","Utah","84148-0001",{"type":55,"coordinates":593},[594,595],-111.89105,40.76078,{"lat":595,"lon":594},[598],{"name":599,"role":38,"phone":600,"phoneExt":26,"email":601},"Charles Lui, MD","801-582-1565","Charles.Lui@va.gov",{"facility":603,"status":48,"city":604,"state":605,"zip":606,"country":52,"countryCode":53,"cosmosGeoPoint":607,"geoPoint":611,"contacts":612},"Hunter Holmes McGuire VA Medical Center, Richmond, VA","Richmond","Virginia","23249",{"type":55,"coordinates":608},[609,610],-77.46026,37.55376,{"lat":610,"lon":609},[613],{"name":614,"role":38,"phone":615,"phoneExt":26,"email":616},"Edward McFalls, MD","804-675-5419","Edward.McFalls@va.gov",{"facility":618,"status":48,"city":619,"state":605,"zip":620,"country":52,"countryCode":53,"cosmosGeoPoint":621,"geoPoint":625,"contacts":626},"Salem VA Medical Center, Salem, VA","Salem","24153-6404",{"type":55,"coordinates":622},[623,624],-80.05476,37.29347,{"lat":624,"lon":623},[627],{"name":628,"role":38,"phone":629,"phoneExt":26,"email":630},"Ali Iranmanesh, MD","540-983-1071","Ali.Iranmanesh@va.gov",{"facility":632,"status":48,"city":633,"state":634,"zip":635,"country":52,"countryCode":53,"cosmosGeoPoint":636,"geoPoint":640,"contacts":641},"Huntington VA Medical Center, Huntington, WV","Huntington","West Virginia","25704-9300",{"type":55,"coordinates":637},[638,639],-82.44515,38.41925,{"lat":639,"lon":638},[642],{"name":643,"role":38,"phone":644,"phoneExt":645,"email":646},"Tina Sias, MD","304-429-6755","2580","Tina.Sias@va.gov",{"facility":648,"status":48,"city":649,"state":650,"zip":651,"country":52,"countryCode":53,"cosmosGeoPoint":652,"geoPoint":656,"contacts":657},"Clement J. Zablocki VA Medical Center, Milwaukee, WI","Milwaukee","Wisconsin","53295-0001",{"type":55,"coordinates":653},[654,655],-87.90647,43.0389,{"lat":655,"lon":654},[658],{"name":659,"role":38,"phone":660,"phoneExt":661,"email":662},"Cynthia Kay, MD","414-384-2000","42263","Cynthia.Kay@va.gov",{"type":664,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100279270","phase-4-investigation-of-metformin-in-pre-diabetes-on-atherosclerotic-cardiovascular-outcomes-100279270",false,"NCT02915198","Investigation of Metformin in Pre-Diabetes on Atherosclerotic Cardiovascular OuTcomes","CSP #2002 - Investigation of Metformin in Pre-Diabetes on Atherosclerotic Cardiovascular OuTcomes (VA-IMPACT)","VA-IMPACT","Inclusion Criteria:\n\n1. Pre-diabetes: This condition is fulfilled by HbA1c of at least 5.7%, but less than 6.5%; or two measurements of fasting plasma glucose (on separate days) of 100-125 mg\u002FdL; or a 2-hour plasma glucose level of 140-199 mg\u002FdL following a 75 g glucose load oral glucose tolerance test.\n2. Established atherosclerotic cardiovascular disease: Qualifying participants must have evidence of atherosclerotic disease in at least one of the following vascular beds: coronary, cerebrovascular, or peripheral arterial circulation.\n\nCoronary artery disease is fulfilled by at least one of (1), (2), or (3):\n\n1. History of myocardial infarction at least one month prior to randomization.\n2. History of percutaneous coronary intervention or coronary artery bypass surgery at least one month prior to randomization.\n3. Angiographic evidence of coronary stenosis of at least 50% in at least two major epicardial coronary arteries.\n\nCerebrovascular disease is fulfilled by at least one of criteria (1) through (4):\n\n1. Documented prior ischemic stroke (at least one month prior to randomization),\n2. Carotid artery stenosis 50% and history of transient ischemic attack or transient ischemic visual symptoms attributable to the identified lesion(s),\n3. Asymptomatic carotid stenosis of at least 70% luminal diameter,\n4. History of carotid revascularization (surgical or catheter-based).\n\nPeripheral arterial disease: Fulfilled by at least one of the following:\n\n1. History of aorto-iliac or peripheral artery intervention (surgical or catheter based) for limb ischemia, or amputation for limb ischemia,\n2. Symptoms of intermittent claudication with ankle:brachial index less than or equal to 0.85.\n\n3\\. Renal function: Estimated glomerular filtration rate at least 45 mL\u002Fmin\u002F1.73 m2.\n\n4\\. Informed consent has been fully executed, and participant agrees to study procedures.\n\nExclusion Criteria:\n\n1. Treatment with metformin or other anti-diabetic medication within 12 months of randomization. Note: In the absence of a diagnosis of diabetes, inpatient treatment with insulin or treatment with an SGLT2 inhibitor (e.g., for heart failure) or a GLP-1 receptor agonist (e.g., for obesity) is not exclusionary.\n2. Treatment with systemic glucocorticoids within 3 months of randomization\n3. Fasting plasma glucose greater than 130 mg\u002FdL measured between screening and randomization visits, or any plasma glucose 180 mg\u002FdL or HbA1c 7.0% measured within 12 months of randomization.\n4. Total CO2 below the local laboratory lower limit of normal on most recent blood chemistry panel\n5. Current treatment with cimetidine, vandetanib, or a systemic treatment with a carbonic anhydrase inhibitor.\n6. Cirrhosis, active hepatitis, or jaundice at time of randomization, or total bilirubin \\> 2 times upper limit of normal\n7. Binge or heavy alcohol consumption within 6 months of randomization\n8. Severe anemia (hemoglobin \\\u003C 10 g\u002FdL)\n9. Prior history of intolerance to metformin\n10. Myocardial infarction, coronary revascularization procedure, or stroke within 1 month of randomization\n11. Uncontrolled hypertension at screening assessment (systolic blood pressure 180 mm Hg or diastolic blood pressure 110 mm Hg\n12. Acute or decompensated congestive heart failure\n13. Expected survival less than study duration\n14. Participants considered to be unable, unwilling, or unreliable to meet protocol requirements\n15. Impaired decision-making capacity, defined by any history of dementia or cognitive impairment\n16. Concurrent participation in another research study involving a randomized comparison of drug or device treatments, unless specifically excepted.\n17. Pregnant, intent to become pregnant during the trial, or lactating\n18. Women of childbearing potential who are not using a highly effective method of contraception","ALL","18 Years",{"count":676,"type":677},7410,"ESTIMATED","INTERVENTIONAL",[680],"PHASE4","This research will help us to learn if the medicine called metformin reduces the risk of death, heart attacks, and\u002For strokes in Veterans who have pre-diabetes and heart or blood vessel problems.",[683,684,9],"Prediabetic State","Atherosclerosis",[9,684,683,686,687,688,689],"Hemoglobin A, Glycosylated","Coronary Artery Disease","Peripheral Arterial Disease","Cerebrovascular Disorders","2025-12-12",{"date":692,"type":693},"2025-12-17","ACTUAL",{"date":695,"type":693},"2023-04-03",{"date":697,"type":677},"2029-09-28",{"name":5,"class":6},40]