Open
Actively Recruiting
Type 2 Diabetes and Blood Brain Barrier Improvement
About
Brief Summary
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.
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
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.
Join this Trial
Contact our clinical trial navigators for opportunities that may be suitable for you
Study Stats
Protocol No.
23-001083
Category
Endocrine and Metabolic Disorders
Principal Investigator
Rajesh Kumar
Location
- UCLA Westwood