RECRUITING

Type 2 Diabetes and Blood Brain Barrier Improvement

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-08-01
Study Completion:2026-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06322212

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosed T2DM
  2. * Outpatient status
  3. * Able to lay flat for imaging
  1. * A previous history of stroke
  2. * Current in-take of thiamine
  3. * Known thiamine allergy
  4. * Seizure disorder
  5. * Head trauma
  6. * Myocardial infarction
  7. * Current pregnancy (if female)
  8. * Diagnosed neuropsychiatric disorders (clinical depression, schizophrenia, manic-depression)
  9. * Diagnosed dementia
  10. * Sleep disordered breathing
  11. * Airway or chest deformities that would interfere with breathing
  12. * Chronic obstructive pulmonary disease
  13. * Cystic fibrosis
  14. * Presence of brain mass lesions
  15. * Any history of drug abuse (e.g., cocaine, tobacco, or cannabis)
  16. * Renal failure (requiring dialysis)
  17. * 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)
  18. * Non-removable insulin pump/glucose sensor
  19. * Braces
  20. * 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)
  21. * Any other contraindications to MRI, such as claustrophobia, or metallic-based tattoos, as per MRI safety website suggestions, will also be excluded.

Contacts and Locations

Study Contact

Rajesh Kumar, PhD
CONTACT
310-206-1699
rkumar@mednet.ucla.edu
Bhaswati Roy, PhD
CONTACT
310-206-6133
broy@mednet.ucla.edu

Study Locations (Sites)

UCLA
Los Angeles, California, 90095
United States

Collaborators and Investigators

Sponsor: University of California, Los Angeles

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-01
Study Completion Date2026-04

Study Record Updates

Study Start Date2024-08-01
Study Completion Date2026-04

Terms related to this study

Keywords Provided by Researchers

  • MRI
  • Thiamine Treatment
  • Thiamine Deficiency
  • Cognition Assessments

Additional Relevant MeSH Terms

  • Type2diabetes