Leukocyte Glucose Index and Severity of Diabetic Ketoacidosis

Elevated Leukocyte Glucose Index (LGI) and Severity of Diabetic Ketoacidosis and Microvascular Complications

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07821814

Enrollment

120

Registered

2026-09-16

Start date

2026-09-10

Completion date

2028-03-01

Last updated

2026-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Diabetic Ketoacidosis

Keywords

Leukocyte Glucose Index, Diabetic ketoacidosis, LGI, DKA severity, Microvascular complications

Brief summary

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.

Detailed description

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
DKA severity according to admission LGI	Baseline	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.

Secondary

Measure	Time frame	Description
Mean LGI according to DKA severity	Baseline	Mean admission Leukocyte Glucose Index value in patients with mild, moderate, and severe diabetic ketoacidosis.
Prevalence of microvascular complications according to LGI	Baseline	Proportion of patients with diabetic nephropathy, retinopathy, or peripheral neuropathy according to admission LGI categories.
Correlation of LGI with biochemical severity markers	Baseline	Correlation coefficient between admission LGI and venous pH, serum bicarbonate, and anion gap, using Spearman or Pearson correlation as appropriate.
Discriminatory performance of LGI for severe DKA	Baseline	Area under the ROC curve, sensitivity, and specificity of admission LGI for identifying severe diabetic ketoacidosis.
Hospital outcomes	Up to 7 days	Mean time to DKA resolution (hours) and length of hospital stay (days).

Contacts

CONTACTHeba H farag, Resident

Heba.17289965@med.aun.edu.eg01110892460

STUDY_CHAIRMahmoud M Ashry, prof

Internal Medicine Department, Assiut University Hospitals

Outcome results