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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06251895
Enrollment
241
Registered
2024-02-09
Start date
2021-08-01
Completion date
2023-11-11
Last updated
2024-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Ketoacidosis

Keywords

Complete blood count, diabetes mellitus, diabetic ketoacidosis, systemic immune inflammation index.

Brief summary

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.

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.

Interventions

OTHERDKA protocol

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

Sponsors

Jahra Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
SIIDay 1 (baseline)SII = (neutrophil × platelet) / lymphocyte.

Secondary

MeasureTime frameDescription
ICU admissionHospital stay up to one weekneed for ICU admission
readmissionwithin 90 daysreadmission because of DKA

Countries

Kuwait

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026