Outcome of Glargine Insulin in Renal Impairment Patients With Diabetic Ketoacidosis

NCT05219942 | Unknown

• 1 other identifier: R 103/ 2020
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (2)

• Mean time to reversal of diabetic ketoacidosis

  Resolution of DKA is defined as blood sugar \<200mg/dl plus any two of serum bicarbonate ≥15,pH\>7.3, and anion gap less than or equal to 12

  48 hours

• Total crystalline insulin consumption

  Total number of units of insulin infusion consumed for diabetic ketocidosis to resolve

  48 hours

Study Arms (2)

low dose insulin infusion +Subcutaneous saline

PLACEBO COMPARATOR

low dose insulin infusion +Subcutaneous saline

Other: normal saline

low dose insulin infusion +subcutaneous Glargine insulin

ACTIVE COMPARATOR

low dose insulin infusion +subcutaneous Glargine insulin

Drug: Glargine

Interventions

Glargine DRUG

regular low dose insulin infusion 0.1 IU/Kg/hour and subcutaneous Glargine insulin (made by Sanofi®) within the first 2 hours of ICU admission. The dose of insulin glargine will be adjusted according to the calculated (eGFR \> 90 dose = 0.27 IU/kg/day, eGFR 60-89 dose = 0.25 IU/kg/day, eGFR \<60 dose = 0.19 IU/kg/day.

Also known as: insulin

low dose insulin infusion +subcutaneous Glargine insulin

normal saline OTHER

regular low dose insulin infusion 0.1 IU/Kg/hour and subcutaneous saline instead of insulin glargine will be given in the control group.

low dose insulin infusion +Subcutaneous saline

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients.
• Type I and type II diabetes mellitus.
• Patients on insulin and/or oral hypoglycemic therapy.
• Duration of diabetes more than 5 years.
• Medical and surgical patients.

You may not qualify if:

• Severe persistent hypotension (SBP \<80 inspite of receiving 1000ml of normal saline).
• Acute myocardial infarction.
• Progressive renal failure or end stage renal disease defined as eGFR \< 15ml/min.
• Liver cell failure.
• Pregnancy.
• Need for emergency surgery

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, 11566, Egypt

RECRUITING

Related Publications (5)

• Barski L, Kezerle L, Zeller L, Zektser M, Jotkowitz A. New approaches to the use of insulin in patients with diabetic ketoacidosis. Eur J Intern Med. 2013 Apr;24(3):213-6. doi: 10.1016/j.ejim.2013.01.014. Epub 2013 Feb 8.

  PMID: 23395363 BACKGROUND

• Barski L, Brandstaetter E, Sagy I, Jotkowitz A. Basal insulin for the management of diabetic ketoacidosis. Eur J Intern Med. 2018 Jan;47:14-16. doi: 10.1016/j.ejim.2017.08.025. Epub 2017 Aug 31.

  PMID: 28864157 BACKGROUND

• Chapter 1: Definition and classification of CKD. Kidney Int Suppl (2011). 2013 Jan;3(1):19-62. doi: 10.1038/kisup.2012.64. No abstract available.

  PMID: 25018975 BACKGROUND

• Savage MW, Dhatariya KK, Kilvert A, Rayman G, Rees JA, Courtney CH, Hilton L, Dyer PH, Hamersley MS; Joint British Diabetes Societies. Joint British Diabetes Societies guideline for the management of diabetic ketoacidosis. Diabet Med. 2011 May;28(5):508-15. doi: 10.1111/j.1464-5491.2011.03246.x.

  PMID: 21255074 BACKGROUND

• Svensson M, Yu ZW, Eriksson JW. A small reduction in glomerular filtration is accompanied by insulin resistance in type I diabetes patients with diabetic nephrophathy. Eur J Clin Invest. 2002 Feb;32(2):100-9. doi: 10.1046/j.1365-2362.2002.00949.x.

  PMID: 11895456 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Insulin Glargine; Insulin; Saline Solution

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Proinsulin; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Eeman A Bayoumi, MD

CONTACT

0021001635744; eeman_aboubakr@med.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Patients of both groups know that they will receive crystalline insulin infusion.However they are not told whether they receive glargine insulin or not.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 9, 2022
• First Posted: February 2, 2022
• Study Start: December 1, 2020
• Primary Completion: June 1, 2022
• Study Completion: July 1, 2022
• Last Updated: June 7, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)