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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

241 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-01

Study Completion Date

2023-11-11

Brief Summary

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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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Detailed Description

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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.

Conditions

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Diabetic Ketoacidosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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mild DKA

pH \< 7.3 or serum bicarbonate \<18 mmol/L

DKA protocol

Intervention Type OTHER

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

moderate DKA

pH \< 7.2 or serum bicarbonate \<10 mmol/L

DKA protocol

Intervention Type OTHER

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

severe DKA

pH \< 7.1 or serum bicarbonate \<5 mmol/L

DKA protocol

Intervention Type OTHER

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

Interventions

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DKA protocol

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No