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NCT Number: NCT07821814

Leukocyte Glucose Index and Severity of Diabetic Ketoacidosis

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. DKA severity according to admission LGI

    Time frame: 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 outcomes

  1. Mean LGI according to DKA severity

    Time frame: Baseline

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

  2. Prevalence of microvascular complications according to LGI

    Time frame: Baseline

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

  3. Correlation of LGI with biochemical severity markers

    Time frame: Baseline

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

  4. Discriminatory performance of LGI for severe DKA

    Time frame: Baseline

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

  5. Hospital outcomes

    Time frame: Up to 7 days

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

Study contacts

Contact information is provided by the study sponsor or research team.

Heba H farag, Resident

CONTACT

[email protected]

01110892460

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 16, 2026
Registry last updated
Sep 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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