Type 2 Diabetes and Blood Brain Barrier Improvement

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of California, Los Angeles
Study ID
NCT06322212
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Type2diabetes

Eligibility Criteria

Sex
ALL
Age
40 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Thiamine — DIETARY_SUPPLEMENT
    Participants will be provided instruction to take one 500 mg capsule of Thiamine (Vitamin B1) each day in the morning for 3-months.
  • Placebo — OTHER
    Participants will be provided instruction to take one capsule (placebo) each day in the morning for 3-months.

Study Details

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.

Key Dates

Start date
Aug 1, 2024
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
52 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: BBB function, cognition, and mood in T2DM adults with Thiamine treatment.
    Analyze BBB function, cognition, and mood in T2DM adults with Thiamine treatment and compare to the placebo group.
  • Placebo Comparator: BBB function, cognition, and mood in T2DM adults without Thiamine treatment.
    Analyze BBB function, cognition, and mood in T2DM adults without Thiamine treatment and compare to the Thiamine treatment group.

Primary Outcome Measure

Assess if BBB function has been repaired. [ Time Frame: After 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UCLALos AngelesCalifornia90095
Rajesh Kumar, PHD
[email protected]
310-825-1808
Dineth R Karunamuni, MS
[email protected]
856-701-5332
Rajesh Kumar, PHD (PRINCIPAL_INVESTIGATOR)

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