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Type 2 Diabetes and Blood Brain Barrier Improvement
Type 2 Diabetes Mellitus and Blood Brain Barrier Improvement - A Randomized Clinical Trial
Who can join
Ages 40 to 65 · All sexes
Full eligibility criteria
Inclusion Criteria: * Diagnosed T2DM * Outpatient status * Able to lay flat for imaging Exclusion Criteria: * A previous history of stroke * Current in-take of thiamine * Known thiamine allergy * Seizure disorder * Head trauma * Myocardial infarction * Current pregnancy (if female) * Diagnosed neuropsychiatric disorders (clinical depression, schizophrenia, manic-depression) * Diagnosed dementia * Sleep disordered breathing * Airway or chest deformities that would interfere with breathing * Chronic obstructive pulmonary disease * Cystic fibrosis * Presence of brain mass lesions * Any history of drug abuse (e.g., cocaine, tobacco, or cannabis) * Renal failure (requiring dialysis) * 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) * Non-removable insulin pump/glucose sensor * Braces * 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) * Any other contraindications to MRI, such as claustrophobia, or metallic-based tattoos, as per MRI safety website suggestions, will also be excluded.
About the study
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.
What is being tested
- Thiamine (dietary supplement)
- Placebo (other)
Sponsor: University of California, Los Angeles · Participants: 52 · Started: Aug 1, 2024
Contact the study team
- Rajesh Kumar, PhD · Phone: 310-206-1699
- Dineth R Karunamuni, MS · Phone: 856-701-5332
Official record on ClinicalTrials.gov — NCT06322212
Locations in the U.S.
| California | UCLA, Los Angeles |
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.