Phase 1 Randomized Clinical Trial of Arginine Hydrochloride to Reduce Duration of Diabetic Ketoacidosis in Type 2 Diabetes

What this Trial Is About

Researchers are investigating a form of diabetic ketoacidosis (DKA) that occurs in adults with a "ketone-prone" type 2 diabetes, where the pancreas temporarily reduces insulin production during severe high blood sugar. This study evaluates whether an intravenous infusion of arginine, an amino acid that can stimulate the pancreas to release insulin when glucose is high, can safely increase the body's own insulin and speed recovery. The trial is a phase 1/2 randomized, double-blind, placebo-controlled study enrolling 60 adults with DKA in emergency departments. Participants will receive standard care for DKA, including fluids, insulin, and electrolyte management, plus a single 30-minute intravenous infusion of either arginine hydrochloride 30 grams or a placebo saline solution. The infusion starts as soon as possible after recognizing DKA, and both treatments are given under blinded conditions with matching procedures. Blood samples will be taken before and at 10, 30, and 90 minutes after infusion to measure insulin secretion and amino acid levels. During the study, participants will be closely monitored for safety, including vital signs and symptoms like flushing, nausea, or headache. Researchers will assess insulin secretion, ketone clearance, and total insulin use over 24 hours. Additional tests will explore blood markers and mitochondrial function in platelets. Follow-up will continue up to 90 days to check for any delayed effects. The total participation involves initial treatment and monitoring during hospitalization with follow-up contact afterward.

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