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 @ 4:19 AM
Ignite Modification Date:
2025-12-25 @ 4:19 AM
NCT ID:
NCT03618420
Eligibility Criteria:
Inclusion Criteria:
* Antibody+ T1D with \<10 yr duration
* Age 12-21 years
* BMI ≥ 5%ile
* Weight\<350 lbs and \> 57 lbs.
* No anemia
* HbA1c \<12%
Exclusion Criteria:
* Severe illness, recent diabetic ketoacidosis (DKA)
* Estimated Glomerular Filtration Rate (eGFR) \<60ml/min/1.73m2 or creatinine \> 1.5mg/dl or history of ACR≥300mg/g
* Anemia or allergy to shellfish or iodine
* Pregnancy or nursing
* MRI scanning contraindications (claustrophobia, implantable devices, \>350 lbs)
* Angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARB), diuretics, sodium-glucose co-transport (SGLT) 2 or 1 blockers, daily NSAIDs or aspirin, sulfonamides, procaine, thiazolsulfone or probenecid, atypical antipsychotics and steroids
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
21 Years
Study:
NCT03618420
Study Brief:
Protocol Section:
NCT03618420