Type2diabetesEarly Phase 1NCT06322212
Type 2 Diabetes and Blood Brain Barrier Improvement
A Early Phase 1 study testing Thiamine in people with Type2diabetes, run by University of California, Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Type2diabetes
- What is being tested?
- Thiamine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2024to 31 Mar 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed T2DM
- Outpatient status
- Able to lay flat for imaging
Who cannot join
- A previous history of stroke
- Current in-take of thiamine
- Known thiamine allergy
- Seizure disorder
- Head trauma
- Myocardial infarction
Show all 21Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UCLA
Los Angeles, California, 90095
Rajesh Kumar, PHD, 310-825-1808, rkumar@mednet.ucla.edu
Dineth R Karunamuni, MS, 856-701-5332, dkarunamuni@mednet.ucla.edu
About this study
Official title: Type 2 Diabetes Mellitus and Blood Brain Barrier Improvement - A Randomized Clinical 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.
Read the detailed description
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.
- Conditions
- Type2diabetes
- Being tested
- Thiamine, Placebo
- Keywords
- MRI, Thiamine Treatment, Thiamine Deficiency, Cognition Assessments
- Medical subject headings
- Thiamine Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThiamineDietary supplement
Also called B1
Participants will be provided instruction to take one 500 mg capsule of Thiamine (Vitamin B1) each day in the morning for 3-months.
PlaceboOther
Also called inactive
Participants will be provided instruction to take one capsule (placebo) each day in the morning for 3-months.
| Study group | Role | What they receive |
|---|---|---|
| BBB function, cognition, and mood in T2DM adults with Thiamine treatment. | Experimental | Analyze BBB function, cognition, and mood in T2DM adults with Thiamine treatment and compare to the placebo group. Receives: Dietary Supplement: Thiamine |
| BBB function, cognition, and mood in T2DM adults without Thiamine treatment. | Placebo comparator | Analyze BBB function, cognition, and mood in T2DM adults without Thiamine treatment and compare to the Thiamine treatment group. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess if BBB function has been repaired.
Assess the function of the Blood Brain Barrier.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: After 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start1 Aug 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (282)Papers the sponsor has linked to this study.
- Other trials for Type2diabetesStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Compare BBB function, cognition, and mood in T2DM adults with and without Thiamine treatment.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Rajesh Kumar, PhD, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06322212
- Sponsor's protocol ID
- 23-001083
- Other IDs
- 1R21AG085268-01
- Status last verified
- Mar 2026
- First submitted
- 7 Mar 2024
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Umegaki H. Type 2 diabetes as a risk factor for cognitive impairment: current insights. Clin Interv Aging. 2014 Jun 28;9:1011-9. doi: 10.2147/CIA.S48926. eCollection 2014.
PubMed 25061284Vincent C, Hall PA. Executive Function in Adults With Type 2 Diabetes: A Meta-Analytic Review. Psychosom Med. 2015 Jul-Aug;77(6):631-42. doi: 10.1097/PSY.0000000000000103.
PubMed 25469685Nooyens AC, Baan CA, Spijkerman AM, Verschuren WM. Type 2 diabetes and cognitive decline in middle-aged men and women: the Doetinchem Cohort Study. Diabetes Care. 2010 Sep;33(9):1964-9. doi: 10.2337/dc09-2038. Epub 2010 Jun 2.
PubMed 20519662Spauwen PJ, Kohler S, Verhey FR, Stehouwer CD, van Boxtel MP. Effects of type 2 diabetes on 12-year cognitive change: results from the Maastricht Aging Study. Diabetes Care. 2013 Jun;36(6):1554-61. doi: 10.2337/dc12-0746. Epub 2012 Dec 28.
PubMed 23275366Worrall G, Moulton N, Briffett E. Effect of type II diabetes mellitus on cognitive function. J Fam Pract. 1993 Jun;36(6):639-43.
PubMed 8505607Lowe LP, Tranel D, Wallace RB, Welty TK. Type II diabetes and cognitive function. A population-based study of Native Americans. Diabetes Care. 1994 Aug;17(8):891-6. doi: 10.2337/diacare.17.8.891.
PubMed 7956638Dey J, Misra A, Desai NG, Mahapatra AK, Padma MV. Cognitive function in younger type II diabetes. Diabetes Care. 1997 Jan;20(1):32-5. doi: 10.2337/diacare.20.1.32.
PubMed 9028690McGuire LC, Ford ES, Ajani UA. The impact of cognitive functioning on mortality and the development of functional disability in older adults with diabetes: the second longitudinal study on aging. BMC Geriatr. 2006 May 1;6:8. doi: 10.1186/1471-2318-6-8.
PubMed 16650284Diaz-Venegas C, Schneider DC, Myrskyla M, Mehta NK. Life expectancy with and without cognitive impairment by diabetes status among older Americans. PLoS One. 2017 Dec 29;12(12):e0190488. doi: 10.1371/journal.pone.0190488. eCollection 2017.
PubMed 29287106Cuevas H, Stuifbergen A. Perceived cognitive deficits are associated with diabetes self-management in a multiethnic sample. J Diabetes Metab Disord. 2017 Feb 15;16:7. doi: 10.1186/s40200-017-0289-3. eCollection 2017.
PubMed 28239597Yaffe K, Lindquist K, Vittinghoff E, Barnes D, Simonsick EM, Newman A, Satterfield S, Rosano C, Rubin SM, Ayonayon HN, Harris T; Health, Aging and Body Compsition Study. The effect of maintaining cognition on risk of disability and death. J Am Geriatr Soc. 2010 May;58(5):889-94. doi: 10.1111/j.1532-5415.2010.02818.x. Epub 2010 Apr 6.
PubMed 20406308Lavery LL, Dodge HH, Snitz B, Ganguli M. Cognitive decline and mortality in a community-based cohort: the Monongahela Valley Independent Elders Survey. J Am Geriatr Soc. 2009 Jan;57(1):94-100. doi: 10.1111/j.1532-5415.2008.02052.x. Epub 2008 Nov 3.
PubMed 19016932Gatlin PK, Insel KC. Severity of Type 2 Diabetes, Cognitive Function, and Self-Care. Biol Res Nurs. 2015 Oct;17(5):540-8. doi: 10.1177/1099800414557565. Epub 2014 Nov 11.
PubMed 25391255Feil DG, Zhu CW, Sultzer DL. The relationship between cognitive impairment and diabetes self-management in a population-based community sample of older adults with Type 2 diabetes. J Behav Med. 2012 Apr;35(2):190-9. doi: 10.1007/s10865-011-9344-6. Epub 2011 Apr 19.
PubMed 21503710Tomlin A, Sinclair A. The influence of cognition on self-management of type 2 diabetes in older people. Psychol Res Behav Manag. 2016 Jan 21;9:7-20. doi: 10.2147/PRBM.S36238. eCollection 2016.
PubMed 26855601
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Type 2 Diabetes Mellitus and Blood Brain Barrier Improvement - A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06322212
- Acronym / sponsor ID
- 23-001083
- Conditions
- Type2diabetes
- Keywords
- MRI, Thiamine Treatment, Thiamine Deficiency, Cognition Assessments
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 20 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Compare BBB function, cognition, and mood in T2DM adults with and without Thiamine treatment.
| Arm | Type | Receives |
|---|---|---|
| BBB function, cognition, and mood in T2DM adults with Thiamine treatment. | Experimental | Dietary Supplement: ThiamineAnalyze BBB function, cognition, and mood in T2DM adults with Thiamine treatment and compare to the placebo group. |
| BBB function, cognition, and mood in T2DM adults without Thiamine treatment. | Placebo comparator | Other: PlaceboAnalyze BBB function, cognition, and mood in T2DM adults without Thiamine treatment and compare to the Thiamine treatment group. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed T2DM
- Outpatient status
- Able to lay flat for imaging
Key exclusion criteria (21 listed)
- A previous history of stroke
- Current in-take of thiamine
- Known thiamine allergy
- Seizure disorder
- Head trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ThiamineAlso: B1Participants will be provided instruction to take one 500 mg capsule of Thiamine (Vitamin B1) each day in the morning for 3-months. | Dietary supplement | BBB function, cognition, and mood in T2DM adults with Thiamine treatment. |
| PlaceboAlso: inactiveParticipants will be provided instruction to take one capsule (placebo) each day in the morning for 3-months. | Other | BBB function, cognition, and mood in T2DM adults without Thiamine treatment. |
Primary outcome
Assess if BBB function has been repaired.
Time frame: After 3 months
Assess the function of the Blood Brain Barrier.
Analyze blood serum S100β levels.
Time frame: After 3 months
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.
Examine cognition in T2DM adults with thiamine treatment.
Time frame: After 3 months
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.
Cognition assessment in T2DM adults after thiamine treatment.
Time frame: After 3 months
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.
Examine depression in T2DM adults with thiamine treatment.
Time frame: After 3 months
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.
Assess anxiety in T2DM adults with thiamine treatment.
Time frame: After 3 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Background: PubMed 25061284Umegaki H. Type 2 diabetes as a risk factor for cognitive impairment: current insights. Clin Interv Aging. 2014 Jun 28;9:1011-9. doi: 10.2147/CIA.S48926. eCollection 2014.
- Background: PubMed 25469685Vincent C, Hall PA. Executive Function in Adults With Type 2 Diabetes: A Meta-Analytic Review. Psychosom Med. 2015 Jul-Aug;77(6):631-42. doi: 10.1097/PSY.0000000000000103.
- Background: PubMed 20519662Nooyens AC, Baan CA, Spijkerman AM, Verschuren WM. Type 2 diabetes and cognitive decline in middle-aged men and women: the Doetinchem Cohort Study. Diabetes Care. 2010 Sep;33(9):1964-9. doi: 10.2337/dc09-2038. Epub 2010 Jun 2.
- Background: PubMed 23275366Spauwen PJ, Kohler S, Verhey FR, Stehouwer CD, van Boxtel MP. Effects of type 2 diabetes on 12-year cognitive change: results from the Maastricht Aging Study. Diabetes Care. 2013 Jun;36(6):1554-61. doi: 10.2337/dc12-0746. Epub 2012 Dec 28.
- Background: PubMed 8505607Worrall G, Moulton N, Briffett E. Effect of type II diabetes mellitus on cognitive function. J Fam Pract. 1993 Jun;36(6):639-43.
- Background: PubMed 7956638Lowe LP, Tranel D, Wallace RB, Welty TK. Type II diabetes and cognitive function. A population-based study of Native Americans. Diabetes Care. 1994 Aug;17(8):891-6. doi: 10.2337/diacare.17.8.891.
- Background: PubMed 9028690Dey J, Misra A, Desai NG, Mahapatra AK, Padma MV. Cognitive function in younger type II diabetes. Diabetes Care. 1997 Jan;20(1):32-5. doi: 10.2337/diacare.20.1.32.
- Background: PubMed 16650284McGuire LC, Ford ES, Ajani UA. The impact of cognitive functioning on mortality and the development of functional disability in older adults with diabetes: the second longitudinal study on aging. BMC Geriatr. 2006 May 1;6:8. doi: 10.1186/1471-2318-6-8.
- Background: PubMed 29287106Diaz-Venegas C, Schneider DC, Myrskyla M, Mehta NK. Life expectancy with and without cognitive impairment by diabetes status among older Americans. PLoS One. 2017 Dec 29;12(12):e0190488. doi: 10.1371/journal.pone.0190488. eCollection 2017.
- Background: PubMed 28239597Cuevas H, Stuifbergen A. Perceived cognitive deficits are associated with diabetes self-management in a multiethnic sample. J Diabetes Metab Disord. 2017 Feb 15;16:7. doi: 10.1186/s40200-017-0289-3. eCollection 2017.
- Background: PubMed 20406308Yaffe K, Lindquist K, Vittinghoff E, Barnes D, Simonsick EM, Newman A, Satterfield S, Rosano C, Rubin SM, Ayonayon HN, Harris T; Health, Aging and Body Compsition Study. The effect of maintaining cognition on risk of disability and death. J Am Geriatr Soc. 2010 May;58(5):889-94. doi: 10.1111/j.1532-5415.2010.02818.x. Epub 2010 Apr 6.
- Background: PubMed 19016932Lavery LL, Dodge HH, Snitz B, Ganguli M. Cognitive decline and mortality in a community-based cohort: the Monongahela Valley Independent Elders Survey. J Am Geriatr Soc. 2009 Jan;57(1):94-100. doi: 10.1111/j.1532-5415.2008.02052.x. Epub 2008 Nov 3.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Thiamine in people with Type2diabetes, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rajesh Kumar, PhD (310-206-1699, rkumar@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess if BBB function has been repaired. (time frame: After 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06322212, which also lists 282 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.