Improving brain function in adults with Type 2 diabetes using thiamine
Type 2 Diabetes Mellitus and Blood Brain Barrier Improvement - A Randomized Clinical Trial
This study is testing if taking thiamine can help improve brain function and mood in adults with Type 2 diabetes.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 40 Years to 65 Years |
| Sex | All |
| Sponsor | University of California, Los Angeles Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT06322212 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of thiamine (vitamin B1) treatment on brain function in adults diagnosed with Type 2 diabetes mellitus (T2DM). Participants will undergo brain MRI scans, cognitive assessments, blood tests, and questionnaires to evaluate the potential benefits of thiamine supplementation. The study aims to determine if thiamine can improve blood-brain barrier function and subsequently enhance cognitive and mood functions in T2DM patients. Participants will visit UCLA twice over a six-month period for assessments lasting approximately 2.5 to 3 hours each.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with Type 2 diabetes who are outpatient and can comfortably undergo MRI imaging.
Not a fit: Patients with a history of stroke, current thiamine intake, or certain neurological and psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve cognitive function and mood in patients with Type 2 diabetes, potentially reducing the risk of dementia.
How similar studies have performed: Pre-clinical studies have suggested that thiamine treatment may improve blood-brain barrier function, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Los Angeles, California
- UCLA — Los Angeles, California, United States (Recruiting)
Study contacts
- Study coordinator: Rajesh Kumar, PhD
- Email: rkumar@mednet.ucla.edu
- Phone: 310-206-1699
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.