[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100540851":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":35,"locations":45,"responsibleParty":67,"collaborators":69,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":34,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":34,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":48,"whyStopped":34,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"University of California, Los Angeles","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"BBB function, cognition, and mood in T2DM adults with Thiamine treatment.","EXPERIMENTAL","Analyze BBB function, cognition, and mood in T2DM adults with Thiamine treatment and compare to the placebo group.",[13],"Dietary Supplement: Thiamine",{"label":15,"type":16,"description":17,"interventionNames":18},"BBB function, cognition, and mood in T2DM adults without Thiamine treatment.","PLACEBO_COMPARATOR","Analyze BBB function, cognition, and mood in T2DM adults without Thiamine treatment and compare to the Thiamine treatment group.",[19],"Other: Placebo",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","Thiamine","Participants will be provided instruction to take one 500 mg capsule of Thiamine (Vitamin B1) each day in the morning for 3-months.",[9],[27],"B1",{"type":6,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Placebo","Participants will be provided instruction to take one capsule (placebo) each day in the morning for 3-months.",[15],[33],"inactive",null,[36,41],{"name":37,"role":38,"phone":39,"phoneExt":34,"email":40},"Rajesh Kumar, PhD","CONTACT","310-206-1699","rkumar@mednet.ucla.edu",{"name":42,"role":38,"phone":43,"phoneExt":34,"email":44},"Dineth R Karunamuni, MS","856-701-5332","dkarunamuni@mednet.ucla.edu",[46],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"UCLA","RECRUITING","Los Angeles","California","90095","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-118.24368,34.05223,{"lat":58,"lon":57},[61,64,65],{"name":62,"role":38,"phone":63,"phoneExt":34,"email":40},"Rajesh Kumar, PHD","310-825-1808",{"name":42,"role":38,"phone":43,"phoneExt":34,"email":44},{"name":62,"role":66,"phone":34,"phoneExt":34,"email":34},"PRINCIPAL_INVESTIGATOR",{"type":66,"investigatorFullName":37,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"Professor of Anesthesiology and Radiological Sciences",[70],{"name":71,"class":72},"National Institute on Aging (NIA)","NIH","100540851","early-phase-1-type-2-diabetes-and-blood-brain-barrier-improvement-100540851",false,"NCT06322212","Type 2 Diabetes and Blood Brain Barrier Improvement","Type 2 Diabetes Mellitus and Blood Brain Barrier Improvement - A Randomized Clinical Trial","Inclusion Criteria:\n\n* Diagnosed T2DM\n* Outpatient status\n* Able to lay flat for imaging\n\nExclusion Criteria:\n\n* A previous history of stroke\n* Current in-take of thiamine\n* Known thiamine allergy\n* Seizure disorder\n* Head trauma\n* Myocardial infarction\n* Current pregnancy (if female)\n* Diagnosed neuropsychiatric disorders (clinical depression, schizophrenia, manic-depression)\n* Diagnosed dementia\n* Sleep disordered breathing\n* Airway or chest deformities that would interfere with breathing\n* Chronic obstructive pulmonary disease\n* Cystic fibrosis\n* Presence of brain mass lesions\n* Any history of drug abuse (e.g., cocaine, tobacco, or cannabis)\n* Renal failure (requiring dialysis)\n* All T2DM adults with metallic and electronic implants (phrenic or cardiac pacemakers; although some pacemakers and cardioverter defibrillators are safe at a low magnetic field, they are not safe at 3.0-Tesla scanner)\n* Non-removable insulin pump\u002Fglucose sensor\n* Braces\n* Body weight more than 300 pounds (weight and height will be used to calculate BMI to determine if the patient will fit in the scanner and stay within parameters of size restrictions of MRI scanner table)\n* Any other contraindications to MRI, such as claustrophobia, or metallic-based tattoos, as per MRI safety website suggestions, will also be excluded.","ALL","40 Years","65 Years",{"count":84,"type":85},52,"ESTIMATED","INTERVENTIONAL",[88],"EARLY_PHASE1","The majority of T2DM adults show thiamine (vitamin B1) deficiency which may contribute to impaired function. This study will examine patients with T2DM through brain MRI scans, cognition assessments, blood tests, and questionnaires. Our goal is to see if a thiamine treatment (taking vitamin B1 capsules) can improve function. Patients will be asked to come to UCLA two times three months apart and each visit will last about 2.5-3 hours.",[91],"Type2diabetes",[93,94,95,96],"MRI","Thiamine Treatment","Thiamine Deficiency","Cognition Assessments","2026-03-11",{"date":99,"type":100},"2026-03-13","ACTUAL",{"date":102,"type":100},"2024-08-01",{"date":104,"type":85},"2027-03-31",{"name":5,"class":6},1]