Clinical trial NCT06251895: Association of Systemic Immune-inflammation Index and Severity of Diabetic Ketoacidosis in Type 1 Diabetes Mellitus
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Ketoacidosis
Keywords: Complete blood count
diabetes mellitus
diabetic ketoacidosis
systemic immune inflammation index.
Lead sponsor: Jahra Hospital
Sponsor class: OTHER
First posted: 2024-02-09
Enrollment: 241
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Type 1 DM hospitalized because of DKA.

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.

Eligibility criteria: 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

Primary outcomes:
measure: SII
timeFrame: Day 1 (baseline)
Secondary outcomes:
measure: ICU admission
timeFrame: Hospital stay up to one week
measure: readmission
timeFrame: within 90 days
Other outcomes:
Locations:
city: Kuwait
country: Kuwait
facility: Jahra Hospital
state: Jahra
Study officials:
affiliation: Cairo University
name: MOHAMED AON, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dhatariya KK; Joint British Diabetes Societies for Inpatient Care. The management of diabetic ketoacidosis in adults-An updated guideline from the Joint British Diabetes Society for Inpatient Care. Diabet Med. 2022 Jun;39(6):e14788. doi: 10.1111/dme.14788. Epub 2022 Feb 27.
citation: Glaser N, Fritsch M, Priyambada L, Rewers A, Cherubini V, Estrada S, Wolfsdorf JI, Codner E. ISPAD clinical practice consensus guidelines 2022: Diabetic ketoacidosis and hyperglycemic hyperosmolar state. Pediatr Diabetes. 2022 Nov;23(7):835-856. doi: 10.1111/pedi.13406. No abstract available.