Ignite Creation Date:
2025-12-24 @ 2:13 PM
Ignite Modification Date:
2025-12-31 @ 7:36 PM
Study NCT ID:
NCT06251895
Status:
COMPLETED
Last Update Posted:
2024-02-09
First Post:
2024-01-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Association of Systemic Immune-inflammation Index and Severity of Diabetic Ketoacidosis in Type 1 Diabetes Mellitus
Sponsor:
Jahra Hospital
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: