Type 2 Diabetes and Blood Brain Barrier Improvement
Recruiting · NCT06322212 · Interventional (participants receive a specific treatment) · Lead sponsor: University of California, Los Angeles
View the official record on ClinicalTrials.gov →Interventions studied
PlaceboThiamine
What this trial is about
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.
Who can take part
Age range
40 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Early Phase 1
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed across 1 US state.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →