Health TrialsbyHealthPanel

Type 2 Diabetes and Blood Brain Barrier Improvement

ConditionType2diabetes
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age40-65
SponsorUniversity of California, Los Angeles

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Diagnosed T2DM

Outpatient status

Able to lay flat for imaging

Disqualifiers

A previous history of stroke

Current in-take of thiamine

Known thiamine allergy

Seizure disorder

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

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

Treatment groups

52 Participants
are divided into 2 treatment groups
Group A: BBB function, cognition, and mood in T2DM adults with Thiamine treatment.Experimental treatment 1 intervention
Group B: BBB function, cognition, and mood in T2DM adults without Thiamine treatment.Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Assess if BBB function has been repaired.

Assess the function of the Blood Brain Barrier.

Time frame
After 3 months
2

Analyze blood serum S100β levels.

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.

Time frame
After 3 months
3

Examine cognition in T2DM adults with thiamine treatment.

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.

Time frame
After 3 months
4

Cognition assessment in T2DM adults after thiamine treatment.

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.

Time frame
After 3 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, Los Angeles

Lead sponsor

National Institute on Aging (NIA)

Collaborator

Source ClinicalTrials.gov
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