Back to search results

Type 2 Diabetes and Blood Brain Barrier Improvement Study

This study is looking at whether taking thiamine (Vitamin B1) can help improve brain function in adults with Type 2 Diabetes. Many people with Type 2 Diabetes have low levels of thiamine, which might affect how their brain works. You would take one 500 mg thiamine capsule or a placebo (an inactive capsule) every day for three months. Researchers will use brain MRI scans, memory and thinking tests, blood tests, and questionnaires to see if thiamine can repair the blood-brain barrier (a protective layer around the brain) and improve thinking abilities. The study is for adults aged 40 to 65 who have Type 2 Diabetes and can lie flat for imaging. The current status of this study is unclear.

Study design
This interventional study plans to enroll 52 participants. It compares the effects of thiamine to a placebo.
What's involved
You would take a capsule daily for three months. You would also visit UCLA two times, three months apart, with each visit lasting about 2.5-3 hours.
Compensation
Not stated in the trial record.
Follow-up
The primary outcomes, including blood-brain barrier function, S100β levels, and cognition, are measured after three months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06322212

Type 2 Diabetes and Blood Brain Barrier Improvement

Recruiting
EARLY_PHASE1Ages 40–65InterventionalPrevention
University of California, Los Angeles
~52 participants
Updated 2026-03-13 on ClinicalTrials.gov
What's tested:ThiaminePlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Assess if BBB function has been repaired.
Measured over After 3 months
+5 more outcomes measured

Conditions

Type2diabetes

Explore related trials

Type 2 Diabetes Mellitus

Where it's being run

1 sites across 1 states
California1

Who to contact

Rajesh Kumar, PhD
[email protected]
310-206-1699
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Diagnosed T2DM
Outpatient status
Able to lay flat for imaging

Exclusion

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.

What this trial measures

  • Assess if BBB function has been repaired.After 3 months

    Assess the function of the Blood Brain Barrier.

  • Analyze blood serum S100β levels.After 3 months

    Analyze blood serum S100β (marker of BBB integrity) levels to see if they have been reduced in thiamine treated T2DM adults over T2DM adults without thiamine treatment.

  • Examine cognition in T2DM adults with thiamine treatment.After 3 months

    The investigator will examine cognition using the Wide Range Assessment of Memory and Learning 2 (WRAML2) to see if T2DM adults with thiamine treatment show improved cognition over T2DM adults without thiamine treatment.

  • Cognition assessment in T2DM adults after thiamine treatment.After 3 months

    The investigator will assess cognition using the Montreal Cognitive Assessment (MoCA) to see if T2DM adults with thiamine treatment show improved cognition over T2DM adults without thiamine treatment.

  • Examine depression in T2DM adults with thiamine treatment.After 3 months

    The investigator will examine depression using using the Beck Depression Inventory II (BDI-II) to see if T2DM adults with thiamine treatment have an improvement in mood compared to T2DM adults without thiamine treatment.

  • Assess anxiety in T2DM adults with thiamine treatment.After 3 months

    The investigator will assess anxiety using using the Beck Anxiety Inventory (BAI) to see if T2DM adults with thiamine treatment have an improvement in mood compared to T2DM adults without thiamine treatment.