Type 2 Diabetes and Blood Brain Barrier Improvement

Recruiting now · Early Phase 1 · Has a placebo group

Conditions studied: Type2diabetes

In brief

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 facts

Study ID

NCT06322212

Run by

University of California, Los Angeles

People needed

52

Starts

2024-08-01

Expected to finish

2027-03-31

Last updated by the study team

2026-03-13

Who can join

Age: 40 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosed T2DM
• Outpatient status
• Able to lay flat for imaging

You may not qualify if…

• 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.

Where it is running

• UCLA — Los Angeles, California, United States (enrolling)

Full record on ClinicalTrials.gov

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