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

Completed

• Conditions: Diabetic Ketoacidosis
• Interventions: Other: DKA protocol

• Registration Number: NCT06251895
• Lead Sponsor: Jahra Hospital

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.

Study Timeline

• Study Start: 2021-08-01
• Primary Completion: 2022-12-31
• Study Completion: 2023-11-11
• Study First Submitted: 2024-01-23
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-08
• Last Update Submitted: 2024-02-08
• Study First Posted: 2024-02-09
• Last Update Posted: 2024-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 241

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
mild DKA	DKA protocol	pH \< 7.3 or serum bicarbonate \<18 mmol/L
severe DKA	DKA protocol	pH \< 7.1 or serum bicarbonate \<5 mmol/L
moderate DKA	DKA protocol	pH \< 7.2 or serum bicarbonate \<10 mmol/L

Primary Outcome Measures

Name	Time	Method
SII	Day 1 (baseline)	SII = (neutrophil × platelet) / lymphocyte.

Secondary Outcome Measures

Name	Time	Method
ICU admission	Hospital stay up to one week	need for ICU admission
readmission	within 90 days	readmission because of DKA

Trial Locations

Locations (1)

Jahra Hospital; 🇰🇼 Kuwait, Jahra, Kuwait