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NCT06251895 Clinical Trial

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

Diabetic Ketoacidosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06251895
Other study ID # J1 - 18072023
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 1, 2021
Est. completion date November 11, 2023

Study information
Verified date February 2024
Source Jahra Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 241
Est. completion date November 11, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• DKA protocol
IV fluids and IV insulin as per guidelines. reference 1-2

Locations
Country Name City State
Kuwait Jahra Hospital Kuwait Jahra

Sponsors (1)
Lead Sponsor Collaborator
Jahra Hospital

Country where clinical trial is conducted

Kuwait, 

References & Publications (2)

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. — View 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary SII SII = (neutrophil × platelet) / lymphocyte. Day 1 (baseline)
Secondary ICU admission need for ICU admission Hospital stay up to one week
Secondary readmission readmission because of DKA within 90 days
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