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RECRUITINGEarly Phase 1INTERVENTIONAL

Type 2 Diabetes and Blood Brain Barrier Improvement

Type 2 Diabetes Mellitus and Blood Brain Barrier Improvement - A Randomized Clinical Trial

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: - Diagnosed T2DM - Outpatient status - Able to lay flat for imaging Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DIETARY_SUPPLEMENT

Thiamine

Participants will be provided instruction to take one 500 mg capsule of Thiamine (Vitamin B1) each day in the morning for 3-months.

OTHER

Placebo

Participants will be provided instruction to take one capsule (placebo) each day in the morning for 3-months.

Locations (1)

UCLA
Los Angeles, California, United States