NCT06322212 Type 2 Diabetes and Blood Brain Barrier Improvement
| NCT ID | NCT06322212 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | University of California, Los Angeles |
| Condition | Type2diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 52 participants |
| Start Date | 2024-08-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 52 participants in total. It began in 2024-08-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06322212 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 65 Years, studying Type2diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06322212 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06322212 currently recruiting?
Yes, NCT06322212 is actively recruiting participants. Contact the research team at rkumar@mednet.ucla.edu for enrollment information.
Where is the NCT06322212 trial being conducted?
This trial is being conducted at Los Angeles, United States.
Who is sponsoring the NCT06322212 clinical trial?
NCT06322212 is sponsored by University of California, Los Angeles. The trial plans to enroll 52 participants.
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