An Early Phase 1 interventional study of Thiamine and Placebo in Type2diabetes, sponsored by University of California, Los Angeles. Recruiting at 1 site in United States. Open to participants aged 40 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-03-13.
Sponsored by University of California, Los Angeles · Early Phase 1, Interventional, and Prevention
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.
Type 2 diabetes mellitus (T2DM) makes up 90-95% of all diagnosed diabetes mellitus, and is a serious health issue in the United States.1 T2DM adults show significant mood and cognitive deficits, symptoms that are associated with higher morbidity and mortality, poor self-care, and decreased quality of life, and the condition is linked with early dementia and Alzheimer's disease. Brain structural changes emerge in T2DM adults in sites that exert major influence on cognition and mood functions, potentially resulting from impaired blood brain barrier function (BBB). However, it is unclear whether BBB function can be repaired in T2DM adults, reducing impaired cognition and mood functions and early risks of dementia and Alzheimer's disease in the condition.
Several pre-clinical studies suggest the possibility for BBB function repair, including low-cost thiamine intervention. Thiamine is an essential co-factor for carbohydrate metabolism and adequate or higher levels promote aerobic metabolism and reduce neural injury. In addition, reduced thiamine levels are shown contributing to impaired endothelial cell functions and higher doses of thiamine treatment improve endothelial functions. Thus, lower thiamine levels can contribute to neural, as well as endothelial cell dysfunctions, resulting to impaired BBB function. The majority of T2DM adults show thiamine deficiency, which may contribute to impaired BBB function, but it is unclear if the thiamine treatment can improve BBB function in T2DM adults. The investigators hypothesize that thiamine intervention (3-months) will reduce impaired BBB function and will improve cognition and mood functions in T2DM adults with thiamine treatment compared to non-treated T2DM adults.
In summary, the investigators propose that low-cost thiamine treatment for 3-months in T2DM adults will repair BBB dysfunction and improve mood and cognition functions. If studies successful, the findings from this clinical trial might serve as a novel and innovative treatment strategy to repair BBB function, affecting less cognition and mood function, and hence better outcomes in T2DM adults, as well as in other adult conditions with impaired BBB function. This R21 exploratory clinical trial study will provide required data regarding the benefits of a low-cost thiamine intervention that could be implemented on a large-scale clinical trial to repair BBB function in T2DM adults, as congruent to the National Institutes of Health mission, and thus, decrease early risks of dementia and Alzheimer's disease, reduce morbidity and mortality, and increase quality of life in this serious and common T2DM patient population.
18 studies on the registry are indexed under Thiamine Deficiency; 1 is open to participants now.
This study's planned enrollment of 52 is close to the median of 52 across 13 interventional studies indexed under Thiamine Deficiency.
Browse Thiamine Deficiency studies →University of California, Los Angeles is the lead sponsor of 1,170 studies on the registry; 195 are open to participants now.
Of its 95 completed or terminated interventional studies of FDA-regulated products, 70 (74%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Analyze BBB function, cognition, and mood in T2DM adults with Thiamine treatment and compare to the placebo group.
Dietary Supplement: Thiamine
Analyze BBB function, cognition, and mood in T2DM adults without Thiamine treatment and compare to the Thiamine treatment group.
Other: Placebo
Participants will be provided instruction to take one 500 mg capsule of Thiamine (Vitamin B1) each day in the morning for 3-months.
Also known as: B1
Participants will be provided instruction to take one capsule (placebo) each day in the morning for 3-months.
Also known as: inactive
Assess if BBB function has been repaired.
Assess the function of the Blood Brain Barrier.
Time frame: After 3 months
Analyze blood serum S100β levels.
Analyze blood serum S100β (marker of BBB integrity) levels to see if they have been reduced in thiamine treated T2DM adults over T2DM adults without thiamine treatment.
Time frame: After 3 months
Examine cognition in T2DM adults with thiamine treatment.
The investigator will examine cognition using the Wide Range Assessment of Memory and Learning 2 (WRAML2) to see if T2DM adults with thiamine treatment show improved cognition over T2DM adults without thiamine treatment.
Time frame: After 3 months
Cognition assessment in T2DM adults after thiamine treatment.
The investigator will assess cognition using the Montreal Cognitive Assessment (MoCA) to see if T2DM adults with thiamine treatment show improved cognition over T2DM adults without thiamine treatment.
Time frame: After 3 months
Examine depression in T2DM adults with thiamine treatment.
The investigator will examine depression using using the Beck Depression Inventory II (BDI-II) to see if T2DM adults with thiamine treatment have an improvement in mood compared to T2DM adults without thiamine treatment.
Time frame: After 3 months
Assess anxiety in T2DM adults with thiamine treatment.
The investigator will assess anxiety using using the Beck Anxiety Inventory (BAI) to see if T2DM adults with thiamine treatment have an improvement in mood compared to T2DM adults without thiamine treatment.
Time frame: After 3 months
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — The investigator will make every effort to publish data in a timely manner. Once the findings related to changes in blood brain barrier based on brain MRI data before and after thiamine intervention have been published or by the end of award performance period, whichever is sooner, the MRI data, demographics, mood and cognition, and clinical data (devoid of individual identifiers) will be deposited in NIH supported domain-specific data sharing repository (NIMH Data Archive). All data will be labeled with consistent unique identifiers that will make it easily findable in data repository to interested research investigators. Data will be available forever after sharing with data repository to other investigators for secondary analyses.
Supporting information: Clinical study report
Time frame: Once the findings related to changes in blood brain barrier based on brain MRI data before and after thiamine intervention have been published or by the end of award performance period, whichever is sooner.
Access criteria: Any research investigator
Started Aug 2024 (actual). Primary completion is estimated for Dec 2026, 28 months after the start.
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Studies of the drug tested here: Thiamine
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