NCT06322212RecruitingEarly phase 1
Type 2 Diabetes and Blood Brain Barrier Improvement
Type 2 Diabetes Mellitus and Blood Brain Barrier Improvement - A Randomized Clinical Trial
Source: ClinicalTrials.gov · Last updated 13 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 52 (estimated)
- First submitted
- 7 Mar 2024
- Start date
- 1 Aug 2024
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- University of California, Los Angeles
- Diseases
- Type 2 diabetes
- NCT number
- NCT06322212
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 52
- From 1 Aug 2024 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- A previous history of stroke
Other illness
- Known thiamine allergy
- Seizure disorder
- Myocardial infarction
- Diagnosed neuropsychiatric disorders (clinical depression, schizophrenia, manic-depression)
- Diagnosed dementia
- Chronic obstructive pulmonary disease
- 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)
Lab values
- Non-removable insulin pump/glucose sensor
Other
- Current in-take of thiamine
- Head trauma
- Current pregnancy (if female)
- Sleep disordered breathing
- Airway or chest deformities that would interfere with breathing
- Cystic fibrosis
- Presence of brain mass lesions
- 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.
Who the study is looking for
- Diagnosed T2DM
- Outpatient status
- Able to lay flat for imaging
Age in the registry: 40 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UCLA Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.