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

Jahra Hospital

Status: Completed

Conditions: Diabetic Ketoacidosis

Treatments: Other: DKA protocol

Study type: Observational

Funder types: Other

Identifiers

NCT06251895

J1 - 18072023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 241 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

241 participants in 3 patient groups

mild DKA

Description:

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

Treatment:

Other: DKA protocol

moderate DKA

Description:

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

Treatment:

Other: DKA protocol

severe DKA

Description:

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

Treatment:

Other: DKA protocol