Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06322212
Status:
RECRUITING
Last Update Posted:
2024-03-20
First Post:
2024-03-07
Brief Title:
Type 2 Diabetes and Blood Brain Barrier Improvement
Sponsor:
University of California Los Angeles
Organization:
University of California Los Angeles
Study Overview
Official Title:
Type 2 Diabetes Mellitus and Blood Brain Barrier Improvement - A Randomized Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 25-3 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 States1 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 Alzheimers 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 Alzheimers 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 Alzheimers disease reduce morbidity and mortality and increase quality of life in this serious and common T2DM patient population
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 Alzheimers disease reduce morbidity and mortality and increase quality of life in this serious and common T2DM patient population
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None