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Phase 1 Trial of Arginine Hydrochloride for the Management of Diabetic Ketoacidosis in Type 2 Diabetes

RecruitingPhase 1, Phase 2Ages 18 Years - anyAllDavid K Carroll
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In plain words

What the trial is, and whether it could suit you

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" during severe, prolonged high blood sugar. Arginine is a naturally occurring amino acid that can trigger the pancreas to release its own insulin when glucose is high. It is FDA-approved for other uses and has been given intravenously for decades with a strong safety record. Whether a single arginine infusion given early during DKA can safely boost the body's insulin and speed recovery has not been tested. This randomized, double-blind, placebo-controlled, phase 1/2 trial will enroll 60 adults who present to one of four Detroit-area emergency departments with DKA consistent with ketone-prone type 2 diabetes (high glucose and significant ketones). Participants will receive standard DKA care or

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 ฮฒ-hydroxybutyrate (BHB) \>20 mg/dL (โ‰ˆโ‰ฅ1.9 mmol/L). Note: point-of-care capillary BHB โ‰ฅ1.5 mmol/L and/or breath acetone โ‰ฅ0.01% may be used for screening while confirmatory labs are pending; if confirmatory BHB โ‰ค20 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.
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What it tests

  • Arginine hydrochloride
  • Sodium Chloride 0.9%
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Where

1 site
Detroit Medical Center
Detroit, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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