Type 2 Diabetes and Blood Brain Barrier Improvement

Launched by UNIVERSITY OF CALIFORNIA, LOS ANGELES · Mar 13, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how a vitamin called thiamine (or vitamin B1) might help improve brain function in adults with Type 2 diabetes. Many people with this condition have low levels of thiamine, which could affect how their brains work. The researchers will use brain scans, tests to check thinking skills, blood tests, and questionnaires to see if taking thiamine capsules can make a difference. Participants will need to visit UCLA two times, three months apart, with each visit lasting about 2.5 to 3 hours.

To join the study, participants must be diagnosed with Type 2 diabetes and able to lie flat for the brain scans. However, people with certain conditions, such as a history of stroke, current thiamine use, or significant breathing issues, cannot participate. It’s important for potential participants to know that they will undergo some testing to determine if they are eligible and to ensure their safety during the trial. If interested, this could be a great opportunity to contribute to research that may help improve brain health for those living with Type 2 diabetes.

Gender

ALL

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.