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:
2025-12-24 @ 2:17 PM
Ignite Modification Date:
2025-12-24 @ 2:17 PM
NCT ID:
NCT04409795
Eligibility Criteria:
Inclusion Criteria:
* Existing participants in the Joslin 50-Year Medalist Study
* Residing in the United States
* Capable of giving informed consent
* Known detectable C-peptide \>0.05 ng/mL
Exclusion Criteria:
* Known diagnosis of cancer or active inflammatory disease such as rheumatoid arthritis, lupus, and inflammatory bowel disease
* Recent history of myocardial infarction, angioplasty, bypass surgery, heart failure, angina, stroke, or uncontrolled hypertension\>160/100 during the past 3 months
* Known diagnosis of cognitive dysfunction, dementia or Alzheimer's disease
* Pre-existing liver disease or liver function tests (AST or ALT)\>3x the upper limit of normal
* Pre-existing kidney disease (Chronic Kidney Disease Stage IV and below, or estimated glomerular filtration rate\<45 mL/min/1.73 m2)
* Active use of immunosuppressants
* Recipients of prior islet cell or pancreas transplantation
* Inability to travel due to frailty or health reasons
* Donated blood within the previous two (2) months
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
85 Years
Study:
NCT04409795
Study Brief:
Protocol Section:
NCT04409795