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 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 1:23 AM
NCT ID:
NCT07167693
Eligibility Criteria:
Inclusion Criteria:
* Age \>17 years.
* Unscheduled presentation to a participating emergency department with hyperglycemia (serum glucose \>250 mg/dL) and significant ketonemia consistent with DKA, defined as laboratory serum/plasma β-hydroxybutyrate (BHB) \>20 mg/dL (≈≥1.9 mmol/L).
Note: point-of-care capillary BHB ≥1.5 mmol/L and/or breath acetone ≥0.01% may be used for screening while confirmatory labs are pending; if confirmatory BHB ≤20 mg/dL, the participant is a screen failure.
* Clinical phenotype consistent with ketosis-prone type 2 diabetes (no known prior diagnosis of type 1 diabetes).
* Able to provide written informed consent and comply with study procedures in the ED.
Exclusion Criteria:
* Current renal replacement therapy for chronic kidney disease (hemodialysis or peritoneal dialysis).
* Known history of type 1 diabetes mellitus or known GAD65 autoantibody positivity.
* Diagnosed cirrhosis/advanced chronic liver disease.
* Pregnancy (known pregnancy or positive test at screening).
* Known allergy or hypersensitivity to arginine or its components.
* Features of at least moderate acute alcohol intoxication at screening, per treating team.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07167693
Study Brief:
Protocol Section:
NCT07167693