Improving brain function in adults with Type 2 diabetes using thiamine

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• UCLA
  Los Angeles, California, United States Recruiting

Study contacts

• Study coordinator: Rajesh Kumar, PhD
• Email: rkumar@mednet.ucla.edu
• Phone: 310-206-1699

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.