Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2025-12-26 @ 11:13 PM
NCT ID:
NCT06322212
Eligibility Criteria:
Inclusion Criteria:
* Diagnosed T2DM
* Outpatient status
* Able to lay flat for imaging
Exclusion Criteria:
* A previous history of stroke
* Current in-take of thiamine
* Known thiamine allergy
* Seizure disorder
* Head trauma
* Myocardial infarction
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
65 Years
Study:
NCT06322212
Study Brief:
Protocol Section:
NCT06322212