Association of Systemic Immune-inflammation Index and Severity of Diabetic Ketoacidosis in Type 1 Diabetes Mellitus

February 8, 2024 updated by: Mohamed Aon, Jahra Hospital

Association of the Systemic Immune-inflammation Index (SII) and Severity of Diabetic Ketoacidosis in Patients With Type 1 Diabetes Mellitus: A Retrospective Cohort Study

Diabetic ketoacidosis (DKA) is the most serious metabolic complication of type 1 diabetes mellitus (T1DM). Insulin deficiency and inflammation play a role in the pathogenesis of DKA. The investigators aim to assess the systemic immune-inflammation index (SII) as a marker of severity among T1DM patients with DKA and without infection.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Diabetic ketoacidosis (DKA) is one of the most severe acute metabolic complications of diabetes mellitus (DM). Therefore, DKA patients require prompt treatment and any delay in identifying severe DKA cases can lead to worse outcomes. DKA provokes a systemic inflammatory response through increased levels of various cytokines such as interleukin (IL)-8, IL-6, IL-10, tumor necrosis factor-alpha (TNF-α), and IL-1B. This will lead to cellular activation, cellular adhesion, increased oxidative stress, and endothelial damage, possibly contributing to complications. Consequently, surrogate markers of inflammation and immune status may help in the early identification of patients with severe DKA.

The systemic immune-inflammation index (SII) had a better prognostic value compared to NLR and PLR among cancer patients. Recently, studies have suggested a link between SII and increased risk of atherosclerotic cardiovascular disease (ASCVD), hepatic steatosis, and worse outcomes among hypertensive patients and patients with stroke.

Therefore, the investigators aim to examine SII as a marker of severity in T1DM patients with DKA in an uninfected state.

Study Type

Observational

Enrollment (Actual)

241

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kuwait
    • Jahra
      • Kuwait, Jahra, Kuwait, 2675
        • Jahra Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Type 1 DM hospitalized because of DKA.

Description

Inclusion Criteria:

  • Diagnosis of T1DM
  • Hospitalization because of DKA
  • Age ≥ 12 years.

Exclusion Criteria:

  • Diagnosis of T2DM
  • Diagnosis of Infection
  • Renal impairment
  • Malignancy
  • ASCVD (atherosclerotic cardiovascular disease)
  • History of any medical condition or medications that can change CBC parameters or cause metabolic acidosis
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
mild DKA
pH < 7.3 or serum bicarbonate <18 mmol/L
Other: DKA protocol
IV fluids and IV insulin as per guidelines. reference 1-2
moderate DKA
pH < 7.2 or serum bicarbonate <10 mmol/L
Other: DKA protocol
IV fluids and IV insulin as per guidelines. reference 1-2
severe DKA
pH < 7.1 or serum bicarbonate <5 mmol/L
Other: DKA protocol
IV fluids and IV insulin as per guidelines. reference 1-2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SII
Time Frame: Day 1 (baseline)
SII = (neutrophil × platelet) / lymphocyte.
Day 1 (baseline)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ICU admission
Time Frame: Hospital stay up to one week
need for ICU admission
Hospital stay up to one week
readmission
Time Frame: within 90 days
readmission because of DKA
within 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jahra Hospital

Investigators

  • Principal Investigator: MOHAMED AON, PHD, Cairo university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2021

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

November 11, 2023

Study Registration Dates

First Submitted

January 23, 2024

First Submitted That Met QC Criteria

February 8, 2024

First Posted (Estimated)

February 9, 2024

Study Record Updates

Last Update Posted (Estimated)

February 9, 2024

Last Update Submitted That Met QC Criteria

February 8, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • J1 - 18072023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Datasets analyzed during the current study will be available upon reasonable request from the corresponding author and after IRB approval.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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