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Completed

NCT Number: NCT06251895

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

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.

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Key information

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Jahra Hospital

Kuwait, Al Jahra Governorate, 2675

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DKA protocol

Other

IV fluids and IV insulin as per guidelines. reference 1-2

Primary outcomes

  1. SII

    Time frame: Day 1 (baseline)

    SII = (neutrophil × platelet) / lymphocyte.

Secondary outcomes

  1. ICU admission

    Time frame: Hospital stay up to one week

    need for ICU admission

  2. readmission

    Time frame: within 90 days

    readmission because of DKA

Sponsors and collaborators

Lead sponsor

Jahra Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Feb 9, 2024
Registry last updated
Feb 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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