Outcome of Glargine Insulin in Renal Impairment Patients With Diabetic

Status Recruiting

Clinical Trial Summary

The study aims to compare between the use of continuous low dose insulin infusion versus co-administration of low dose continuous insulin infusion and early subcutaneous insulin glargine in diabetic ketoacidosis patients with chronic renal impairment. aim to investigate the effect of using the long acting insulin analogue glargine on the resolution time of diabetic ketoacidosis in renal impairment patients who have altered insulin pharmacokinetics and pharmacodynamics and the rate of adverse effects of this approach

Clinical Trial Description

Diabetic ketoacidosis (DKA) is one of the most common and grave acute complications of diabetes and is a significant cause of morbidity and mortality. The current available guidelines state that the most effective means of insulin delivery during DKA is a continuous low dose infusion of regular insulin. The patients must be admitted to the ICU for frequent and close monitoring .In addition to insulin infusion, correction of dehydration, and electrolyte and acid base disorders is achieved together with identification and treatment of co-morbid precipitating factors . "The Joint British Diabetes Societies guideline for the management of diabetic ketoacidosis" recommends continuation of a long-acting insulin analogue such as insulin glargine during the initial management of DKA because it provides background insulin when the intravenous insulin is discontinue. Administering basal insulin concomitantly with regular insulin infusion was found to be well tolerated, associated with faster resolution of acidosis without any adverse effects; patients required a shorter duration of intravenous insulin infusion and had a lower total dose of intravenous insulin and significantly decreased hyperglycemia after discontinuation of the intravenous insulin . ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05219942
Study type	Interventional
Source	Ain Shams University
Contact	Eeman A Bayoumi, MD
Phone	0021001635744
Email	eeman_aboubakr@med.asu.edu.eg
Status	Recruiting
Phase	N/A
Start date	December 1, 2020
Completion date	July 2022

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Outcome of Glargine Insulin in Renal Impairment Patients With Diabetic Ketoacidosis

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms