Status:
NOT_YET_RECRUITING
Phase 1 Trial of Arginine Hydrochloride for the Management of Diabetic Ketoacidosis in Type 2 Diabetes
Lead Sponsor:
David K Carroll
Collaborating Sponsors:
Wayne State University
Detroit Medical Center
Conditions:
Diabetes (DM)
Diabetic Ketoacidosis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Diabetic ketoacidosis (DKA) is increasingly recognized in adults with "ketone-prone" type 2 diabetes. In many of these patients, the pancreas can still make insulin but becomes temporarily "stunned" d...
Detailed Description
Background and Rationale. A substantial subset of adults with type 2 diabetes develop DKA ("ketone-prone" type 2 diabetes). Many of these patients lack diabetes autoantibodies (A-) and retain recovera...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07167693
Start Date
November 1 2025
End Date
December 31 2027
Last Update
September 11 2025
Active Locations (1)
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1
Detroit Medical Center
Detroit, Michigan, United States, 48201