Recruiting
Early Phase 1

Blood Brain Barrier

Sponsor:

UCLA

Code:

NCT06322212

Conditions

Type2diabetes

Eligibility Criteria

Sex: All

Age: 40 - 65

Healthy Volunteers: Not accepted

Interventions

Thiamine

Placebo

Study Details

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.

Conditions

Type2diabetes

Study ID

NCT06322212

Start date

Aug 1, 2024

Status verified date

Mar, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

52 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

Thiamine

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

Placebo

Participants will be provided instruction to take one capsule (placebo) each day in the morning for 3-months.

Primary outcome measure

  • Assess if BBB function has been repaired. [ Time Frame: After 3 months ]
  • Analyze blood serum S100β levels. [ Time Frame: After 3 months ]
  • Examine cognition in T2DM adults with thiamine treatment. [ Time Frame: After 3 months ]
  • Cognition assessment in T2DM adults after thiamine treatment. [ Time Frame: After 3 months ]
  • Examine depression in T2DM adults with thiamine treatment. [ Time Frame: After 3 months ]
  • Assess anxiety in T2DM adults with thiamine treatment. [ Time Frame: After 3 months ]

Central Contacts and Locations

Central contacts

Rajesh Kumar, PhD

310-206-1699rkumar@mednet.ucla.edu

Dineth R Karunamuni, MS

856-701-5332dkarunamuni@mednet.ucla.edu

Locations

UCLA

Recruiting

Los Angeles, California, United States, 90095

Contacts

Rajesh Kumar, PHD

310-825-1808rkumar@mednet.ucla.edu

Dineth R Karunamuni, MS

856-701-5332dkarunamuni@mednet.ucla.edu

Principal Investigator:

Rajesh Kumar, PHD

More Information

Sponsor

University of California, Los Angeles

Last update posted

Mar 13, 2026

Last verified

Mar, 2026

Keywords

  • MRI
  • Thiamine Treatment
  • Thiamine Deficiency
  • Cognition Assessments

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2026-03-13.