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RecruitingEARLY_Phase 1NCT06322212

Type 2 Diabetes and Blood Brain Barrier Improvement

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Trial Parameters

ConditionType2diabetes
SponsorUniversity of California, Los Angeles
Study TypeINTERVENTIONAL
PhaseEARLY_Phase 1
Enrollment52
SexALL
Min Age40 Years
Max Age65 Years
Start Date2024-08-01
Completion2026-12-31
Interventions
ThiaminePlacebo

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Brief Summary

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.

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 (weigh

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