Diabetic Ketoacidosis

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Review clinical trials related to Diabetic Ketoacidosis. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

Biomarkers of Acute Organ Injury in Pediatric Newly Diagnosed Type 1 Diabetes

Diabetic ketoacidosis (DKA) is a severe metabolic complication in children with newly diagnosed type 1 diabetes mellitus (T1DM) and may be associated with early injury of vital organs such as the kidneys and the heart. Early detection of organ dysfunction is important for identifying children at increased risk for complications. This observational cross-sectional study aims to evaluate biomarkers of acute organ injury and associated clinical and echocardiographic parameters in children with newly diagnosed T1DM presenting with DKA, compared with children with newly diagnosed T1DM without DKA and healthy controls. Biomarkers including KIM-1, NGAL, high-sensitivity troponin, NT-proBNP, interleukin-6, and C-reactive protein will be measured during hospital admission and within the first 24-48 hours of hospitalization.

Participants needed: 45
Trial details
Age: 2-16Biological sex: AllType: ObservationalSponsor: Aristotle University Of ThessalonikiUpdated: Mar 19, 2026Locations: 1
Eligibility criteria

Children aged 2-16 years [+4]

Previous diagnosis of diabetes mellitus [+4]

Status: Recruiting

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

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 ordered by their clinicians. In addition, under blinded conditions they will receive either arginine hydrochloride 30 grams (in 300 mL) or placebo (normal saline), infused intravenously over 30 minutes as early as feasible after DKA is recognized. The main question is whether arginine increases endogenous (self-made) insulin soon after infusion. We will measure C-peptide (a marker released in equal amounts with insulin) and glucose at 10, 30, and 90 minutes after the start of the infusion and calculate the C-peptide/glucose ratio. Secondary measures include the rate of ketone (β-hydroxybutyrate) clearance and the total insulin dose required in the first 24 hours. Additional blood tests will examine arginine and related amino acids, and a small sample of platelets will be used to explore mitochondrial function. Safety will be closely monitored during and after the infusion, and participants will be contacted at 90 days to assess for any delayed problems. Potential risks include temporary flushing, nausea, or headache; the infusion can be stopped at any time if needed. Potential benefits include faster resolution of ketosis and reduced insulin needs, but benefits cannot be guaranteed for individual participants.

Participants needed: 60
Trial details
Phase: Phase 1, Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: David K CarrollUpdated: Feb 12, 2026Locations: 1
Eligibility criteria

Age >17 years. [+3]

Current renal replacement therapy for chronic kidney disease (hemodialysis or pe... [+5]

Status: Recruiting

Clinical and Biological Signs of Dapagliflozin Overdose in ICU Patients With Metformin Poisoning

This study looks at patients admitted to intensive care for drug poisoning involving metformin, a common diabetes medication. Researchers will compare two groups: patients who overdosed on metformin alone and those who took both metformin and dapagliflozin, another diabetes drug. The goal is to find clinical or laboratory signs that could help doctors quickly recognize a dapagliflozin overdose in this context, which could improve treatment and patient outcomes.

Participants needed: 50
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Centre Hospitalier de Saint-DenisUpdated: Sep 25, 2025Locations: 1
Eligibility criteria

Adults aged 18 years or older [+3]

Patients under 18 years of age [+2]

Status: Recruiting

Balanced Multi-Electrolyte Solution Versus Saline Trial for Diabetic KetoAcidosis

The goal of this blinded, cluster cross-over, randomised controlled trial is to determine whether fluid therapy with Plasma-Lyte® 148 increases the number of days alive and days out of hospital to day-28 compared to 0.9% sodium chloride ('0.9% saline') in critically ill patients presenting to the Emergency Department (ED) and deemed to require admission to a critical care area (ICU, HDU) with moderate to severe diabetic ketoacidosis (DKA).

Participants needed: 680
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: The George InstituteUpdated: Sep 17, 2025Locations: 21
Eligibility criteria

Patients in the ED with a primary diagnosis of moderate to severe DKA for whom b... [+6]

Age less than 18 years [+6]

Status: Recruiting

REAMBERIN® 1.5% in Rehydration Therapy of Diabetic Ketoacidosis

A number of scientific papers have been published on the efficacy and safety of adding REAMBERIN® (meglumin sodium succinate), a 1.5% infusion solution, to standard therapy for patients with diabetic ketoacidosis (DKA), which showed that the addition of the medication to DKA therapy at a dose of 10 ml/kg/day or an average of 800.68±151.59 ml on the first day of infusion, leads to a more rapid and successful resolution of DKA, achieving a state of compensation, a more rapid transfer of the patient from the intensive care unit (ICU) and discharge from the hospital. A combined, two-stage, multicenter, randomized, double-blind, phase II/III study with an adaptive design is planned. Stage 1 (phase II) will be a sequential evaluation of 2 doses of the study medication (750 ml and 1500 ml) versus placebo. At the 2nd stage of the study (phase III), additional recruitment of patients will be carried out in two groups in a 1:1 ratio to the experimental group or placebo group, to receive the optimal dose in accordance with the result obtained at stage 1.

Participants needed: 312
Trial details
Phase: Phase 2, Phase 3Age: 18-75Biological sex: AllType: InterventionalSponsor: POLYSAN Scientific & Technological Pharmaceutical CompanyUpdated: Jun 24, 2025Locations: 3
Eligibility criteria

Signed Informed Consent [+8]

Known hypersensitivity to any component of the study drug/standard therapy p [+23]

Status: Recruiting

Serum Ferritin and Prognosis of DKA

the aim of this study is to: evaluate the association between serum ferritin levels and the clinical presentation and short-term prognosis of patients with DKA. Specifically, the correlation between its level and the severity of DKA at presentation and determine its prognostic value in predicting short-term outcomes.

Participants needed: 100
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Sohag UniversityUpdated: May 14, 2025Locations: 1
Eligibility criteria

Adult Aged 18 years old or older . [+2]

Patients age less than 18 years old [+8]

Status: Not yet recruiting

Children with Diabetic Ketoacidosis

In the present work we aim to 1. Response to therapy, During the management of DKA, acid base status, glycemia, and serum electrolytes are measured frequently to monitor the efficacy of treatment, detect complications of DKA and its treatment, and to determine resolution of DKA. 2. Clinical complication like cerebral injury / cerebral edema , cognitive impairment , acute kidney injury , hypokalemia. 3. Severity of DKA

Participants needed: 130
Trial details
Age: 1-18Biological sex: AllType: ObservationalSponsor: Assiut UniversityUpdated: Sep 19, 2024
Eligibility criteria

Other endocrine diseases as thyroid disease or pituitary disease [+2]