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:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2025-12-25 @ 3:18 AM
NCT ID:
NCT03452605
Eligibility Criteria:
Inclusion Criteria:
* non-smoking T1D patients or matched healthy controls
* having diabetes for more than 1 year
* males and females older than 18 years
* stable medications for more than 6 months (no use of cholinesterase inhibitors or prior use of multivitamins was allowed)
* adequate visual and auditory acuity to allow neuropsychological testing.
Exclusion Criteria:
* participant enrolled in any investigational drug study within 2 months or longer, depending on the investigational drug half-life
* history in the past 2 years of epileptic seizures or any major psychiatric disorder
* history or MRI evidence of brain damage, including significant trauma, stroke, hydrocephalus, mental retardation, or serious neurological disorder,
* significant history of alcoholism or drug abuse
* unstable cardiac, renal, lung, liver, or other severe chronic disease
* hypertension (systolic blood pressure ≥160 mmHg, diastolic blood pres-sure ≥100 mmHg) or hypotension (systolic blood pressure \<100 mmHg)
* pacemaker or other medical metal devices that precludes performing MRI,
* chronic inflammatory diseases, including lupus, rheumatoid arthritis, or polymyalgia rheumatic
* macrovascular complications
* retinopathy, nephropathy or neuropathy (microvascular complications)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03452605
Study Brief:
Protocol Section:
NCT03452605