RecruitingEarly Phase 1NCT06322212

Type 2 Diabetes and Blood Brain Barrier Improvement

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


Sponsor

University of California, Los Angeles

Enrollment

52 participants

Start Date

Aug 1, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 40 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether a vitamin called thiamine (vitamin B1) can help improve the blood-brain barrier in people with type 2 diabetes. A leaky blood-brain barrier may contribute to brain complications in people with diabetes. Researchers will use imaging to see if thiamine supplementation makes a difference. **You may be eligible if:** - You have been diagnosed with type 2 diabetes - You are treated as an outpatient (not hospitalized) - You are able to lie flat for imaging scans **You may NOT be eligible if:** - You have a history of stroke - You currently take thiamine supplements - You have a known allergy to thiamine - You have a seizure disorder, history of significant head trauma, or heart attack - You are currently pregnant - You have been diagnosed with depression, schizophrenia, or bipolar disorder - You have dementia or sleep-disordered breathing - You have chronic lung diseases such as COPD or cystic fibrosis - You have a brain tumor - You have a history of drug abuse - You have kidney failure requiring dialysis - You have metallic or electronic implants incompatible with imaging Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTThiamine

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

OTHERPlacebo

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

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NCT06322212


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