Leukocyte Glucose Index and Severity of Diabetic Ketoacidosis

N/ANot Yet RecruitingNCT07821814

Assiut University120 enrolled

Overview

This prospective cohort study aims to evaluate the relationship between admission Leukocyte Glucose Index (LGI) and the severity of diabetic ketoacidosis, as well as the presence of diabetic microvascular complications, among adult patients at Assiut University Hospitals.

Diabetic ketoacidosis is a serious acute complication of diabetes. The Leukocyte Glucose Index (LGI), calculated from admission leukocyte count and blood glucose, is a simple biomarker that may help early risk stratification. This observational study will include adult patients presenting with diabetic ketoacidosis. LGI will be calculated at admission. DKA severity will be classified as mild, moderate, or severe according to ADA criteria. Diabetic microvascular complications (nephropathy, retinopathy, and neuropathy) will be assessed.

Study Type

OBSERVATIONAL

Enrollment

120

Conditions

Diabetic Ketoacidosis Diabetes Mellitus

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * \- Age 18 years or older * Known diabetes mellitus or newly diagnosed diabetes presenting with DKA * Fulfilling accepted clinical and biochemical diagnostic criteria for diabetic ketoacidosis * Written informed consent Exclusion Criteria: * \- Active infection or sepsis judged likely to substantially influence leukocyte count independently of DKA * Hematological malignancy or disorder affecting leukocyte count * Recent chemotherapy, G-CSF, or other treatment markedly altering leukocyte count * Pregnancy * Concurrent acute inflammatory or autoimmune disease likely to affect inflammatory indices * Systemic corticosteroid use before presentation when clinically significant * Incomplete clinical or laboratory data preventing LGI calculation or DKA severity assessment * Refusal to participate

Outcomes

Primary Outcomes

DKA severity according to admission LGI

Proportion of patients with mild, moderate, and severe diabetic ketoacidosis according to admission Leukocyte Glucose Index (LGI) categories. LGI is calculated as leukocyte count (10³/µL) × blood glucose (mg/dL) / 1000.

Time frame: Baseline

Secondary Outcomes

Mean LGI according to DKA severity

Mean admission Leukocyte Glucose Index value in patients with mild, moderate, and severe diabetic ketoacidosis.

Time frame: Baseline

Prevalence of microvascular complications according to LGI

Proportion of patients with diabetic nephropathy, retinopathy, or peripheral neuropathy according to admission LGI categories.

Time frame: Baseline

Correlation of LGI with biochemical severity markers

Correlation coefficient between admission LGI and venous pH, serum bicarbonate, and anion gap, using Spearman or Pearson correlation as appropriate.

Time frame: Baseline

Discriminatory performance of LGI for severe DKA

Area under the ROC curve, sensitivity, and specificity of admission LGI for identifying severe diabetic ketoacidosis.

Time frame: Baseline

Hospital outcomes

Mean time to DKA resolution (hours) and length of hospital stay (days).

Time frame: Up to 7 days

Central Contacts

Heba H farag, Resident

CONTACT

01110892460 Heba.17289965@med.aun.edu.eg

Data from ClinicalTrials.gov

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