Insulin Resistance Intervention After Stroke Trial (IRIS)
Stroke, Myocardial Infarction, Diabetes
About this trial
This is an interventional treatment trial for Stroke focused on measuring stroke, heart attack, diabetes, pioglitazone, insulin resistance
Eligibility Criteria
Inclusion Criteria Ages 40 years or greater at the time of randomization. Ischemic stroke or TIA no less than 14 days and no more than 6 months before randomization Documentation of insulin resistance as defined by a value over 3.0 on the Homeostasis Model Assessment of insulin sensitivity (HOMA). Both ability and willingness to provide informed consent. Presence of none of the exclusion criteria. Exclusion Criteria Permanent Exclusions Severely disabling stroke as indicated by an inability to participate in scheduled follow-up activities. Persons whose ischemic stroke or TIA was related to structural cardiac lesion, significant head trauma, proximal arterial dissection or medical instrumentation. Diabetes mellitus as defined by recent use of medication for diabetes as an out-patient (*see note below) or two fasting plasma blood sugars > 126 mg/dL. HgbA1c > 7.0%. Irreversible medical conditions likely to affect short-term survival or ability to participate in the study protocol. These include: Cancer or other chronic disease with poor prognosis (predicted survival of less than four years). Severe neurologic or psychiatric disease that would complicate the evaluation of study outcomes (e.g., dementia or schizophrenia). History of intolerance to any thiazolidinedione. Pregnancy or desire to become pregnant. Oral contraceptive use. Ongoing use of oral corticosteroids. History of heart failure Active liver disease as defined by known liver disease accompanied by cirrhosis, significant cholestasis, portal hypertension, hepatic encephalopathy, hepatic synthetic dysfunction, or expected significant loss of liver function over the course of the study. History of bladder cancer. Current participation in a conflicting clinical trial. A conflicting clinical trial is defined as a trial with any of following: Intervention that is known to affect the incidence of stroke or myocardial infarction. Intervention that is an experimental drug. Outcome that includes stroke or myocardial infarction. Exclusion for participation in another trial. Temporary Exclusions Persons with temporary exclusions may be enrolled as soon as the exclusion has resolved. Alanine aminotransferase (ALT) >2.5 times the upper limit of normal. Hemoglobin <8.5 g/dl. Moderate or severe pitting edema of the feet or legs (IRIS grade 3 or 4). Carotid surgery or carotid stenting procedure scheduled (delay randomization until 2 weeks following procedure).
Sites / Locations
- University of Alabama
- University of South Alabama
- University of Arizona
- Shanti Clinical Trials (NINDS-CRC site)
- UCSF-Fresno
- Scripps Clinic
- University of Southern California
- University of California
- Stanford University
- University of California-Davis
- University of California
- University of California
- Denver Health and Hospital Authority
- Hartford
- Yale University
- National Rehabilitation Hospital
- University of Florida
- University of Florida
- MIMA Century Research Associates
- Pines Neurological Associates (NINDS-CRC site)
- Floria Neurovascular Institute
- Cook County (Stroger) Hospital
- Rush University
- University of Illinois
- Ingalls Memorial Hospital (NINDS-CRC site)
- Loyola University Medical Center
- OSF St. Francis Medical Center
- Tri-City Neruology (NINDS-CRC site)
- Indiana Medical Research
- Associates In Neurology (NINDS-CRC site)
- Iowa Health Des Moines Clinical Trials Office
- Ruan Neuroscience Center/Mercy Medical Center
- University of Iowa
- Northeast Iowa Medical Education Foundation (NINDS-CRC site)
- Via Christi Regional Medical Center
- University of Kentucky Research Foundation
- Louisiana State University Health Sciences Center
- Penobscot Bay Neurology
- Sinai Hospital of Baltimore
- Johns Hopkins
- Massachusetts General Hospital
- Boston University
- Caritas St. Elizabeth's Medical Center
- Beth Israel Deaconess
- Henry Ford Hospital
- Michigan State University
- Minneapolis Clinic of Neurology
- Hattiesburg Clinic (NINDS-CRC site)
- St. Luke's Brain and Stroke Institute
- Washington University
- St. John's Mercy Medical Center
- St. Louis University
- Billings Clinic
- Advanced Neurology Specialists
- University of Nebraska
- Dartmouth Hitchcock Medical Center
- Cooper University Hospital
- Kessler Medical Rehab Research Corp
- University of New Mexico
- Albany Medical Center
- SUNY Downstate
- New York Methodist Hospital
- SUNY Buffalo
- St. Vincent's Hospital Manhattan
- Cornell University
- University of Rochester
- Southtowns Neurology of WNY (NINDS-CRC site)
- Burke Medical Research Institute
- Clinical Research of Winston-Salem
- Guilford Neurologic Associates
- Altru Health System
- University of Cincinnati
- Case Western Reserve University
- Metrohealth Medical Center
- Cleveland Clinic Foundation
- Ohio State University
- University of Toledo
- Oregon Health & Science University
- Abington Memorial Hospital
- Lankenau Institute for Medical Research
- Penn Stat-Hershey Medical Center (NINDS-CRC site)
- Thomas Jefferson University
- Temple University
- Allegheny Singer Research Institute
- University of Pittsburgh
- Rhode Island Hospital
- University of Tennessee
- Vanderbilt
- Baylor Research Institute
- University of Texas, Southwestern
- Methodist Neurological Institute
- University of Texas
- University of Utah
- University of Vermont
- University of Virginia
- Sentara Medical Group
- University of Wisconsin
- Marshfield Clinic
- Medical College of Wisconsin
- Flinders Medical Centre
- Royal Prince Alfred
- John Hunter Hospital (University of Newcastle)
- Box Hill Hospital (Eastern Health)
- Western Hospital (University of Melbourne)
- Austin Health (National Stroke Research Institute)
- Royal Melbourne Hospital
- Royal Perth
- University of Alberta
- Center for Neurologic Research
- Vancouver Island Health Research Centre
- Robarts Research Institute
- Ottawa Hospital-General Campus
- Intermountain Research Consultants
- St. Michael's Hospital
- Hôpital Charles LeMoyne
- McGill-Montreal General
- McGill-Jewish General
- Centre Hospitalier Affilie Universitaire de Quebec
- CHUM-Centre de recherche, Hôpital Notre-Dame
- Klinikum Altenburger Land
- Neurologische Klinik
- University Hospital-Dresden
- University Duesseldorf/Heinrich-Heine University
- University of Erlangen
- Alfried Krupp Hospital
- University Hospital Frankfurt
- Freiburg University
- Ernst-Moritz-Arndt-University Greifswald
- Martin-Luther-Universitaet Halle-Wittenberg
- University Medical Center Hamburg-Eppendorf
- University Heidelberg
- Friedrich Schiller-University Jena
- University Hospital Mainz
- University Hospital Muenster
- Klinikum der Universitat Muenchen
- University of Ulm
- Soroka Medical Center
- B'nai Zion Medical Center
- Bnai-Zion Medical Center
- Rambam Medical Center
- Wolfson Medical Center
- Rabin Medical Center-Golda Campus
- Sheba Medical Center
- Tel Aviv Medical Center
- Genoa University Hospital
- University of Laquila
- University Vita Salute San Raffaele
- IRCCS FONdazione Istituto Neurologico C. Mondino
- University of Perugia
- University of Rome (S. Andrea Hospital)
- University of Rome La Sapienza
- Sacred Heart Catholic University
- Jazzolino Hospital
- University of Puerto Rico
- Royal Bournemouth
- Queen Elizabeth The Queen Mother Hospital
- Blackpool Victoria Hospital
- Wansbeck General Hospital
- Stobhill Hospital
- Glasgow Royal Infirmary
- Southern General Hospital
- Queen Elizabeth Hospital Gateshead
- Aberdeen Royal Infirmary
- Monklands Hospital
- William Harvey Hospital
- Royal United Hospital
- Addenbrookes Foundation NHS Trust (Cambridge)
- Countess of Chester Foundation Trust
- Dewsbury District Hospital
- Southend University Hospital
- Devon PCT
- Royal Devon and Exeter
- Royal Surrey County Hospital
- Calderdale Royal Hospital
- The Royal Liverpool and Broadgreen University Hospitals
- University Hospital Aintree
- Kings College London
- Saint Georges University of London
- Luton and Dubstable Hospital
- James Cook University Hospital
- Newcastle upon Tyne
- Torbay Hospital (South Devon Healthcare NHS Foundation Trust)
- North Tyneside General Hospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Pioglitazone
Placebo
pioglitazone
inactive substance