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 @ 3:27 AM
Ignite Modification Date:
2025-12-25 @ 3:27 AM
NCT ID:
NCT05553405
Eligibility Criteria:
Inclusion Criteria:
* Age 18-55 years
* Able to read and write English and provide voluntary informed consent
* Physically and psychiatrically healthy by medical history, physical, psychiatric, neurological, EKG and laboratory examinations
* For Aims 1-3: HbA1C \< 5.7%
* For Aim 4: HbA1C \>6.5% and known diagnosis of T1DM or T2DM
Exclusion Criteria:
* Abnormal labs including Creatinine\>1.5mg/dL, Hematocrit \< 35% for females and \< 39% for males, ALT/AST \>2.5X upper limit of normal, abnormal TSH
* Known significant thyroid, hepatic, neurologic, psychiatric, cerebrovascular, or cardiovascular disease
* \>5% body weight change in last 6 months
* Current or recent regular steroid use in last 6 months, illicit drug use that is deemed to interfere with results including problematic alcohol use as defined by NIAAA
* Current regular use of psychotropic and/or potentially psychoactive prescription medications
* Regular use of any vitamins/supplements that could affect lipids
* Current regular use of non-steroidal anti-inflammatory medications, statins, or lipid lowering agents
* Vaccination in the last month
* Individuals who are classified as "low binders" for the rs6971 polymorphism (\<10% of the population)
* For females, physical or laboratory (-HCG) evidence of pregnancy, seeking pregnancy, or lactating. A urine drug screen and pregnancy test will be performed at screening and prior to the imaging session. Subjects who screen positive will be excluded.
Note: If a subject tests positive for an illicit substance, the PI will determine if the substance would interfere with the results and may terminate participation if applicable. Results of the test would only be noted in the subjects de-identified chart to document the occurrence.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT05553405
Study Brief:
Protocol Section:
NCT05553405