Leukocyte Glucose Index and Severity of Diabetic Ketoacidosis
September 10, 2026 updated by: heba helal farag, Assiut University
Elevated Leukocyte Glucose Index (LGI) and Severity of Diabetic Ketoacidosis and Microvascular Complications
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.
Study Overview
Status
Not yet recruiting
Conditions
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.
Study Type
Observational
Enrollment (Estimated)
120
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Heba H farag, Resident
- Phone Number: 01110892460
- Email: Heba.17289965@med.aun.edu.eg
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Adult patients presenting with diabetic ketoacidosis to the Internal Medicine Department and Emergency Department of Assiut University Hospitals.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Single cohort: Adults with diabetic ketoacidosis
Adult patients presenting with diabetic ketoacidosis who will have Leukocyte Glucose Index calculated at admission and will be assessed for DKA severity and microvascular complications.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean LGI according to DKA severity
Time Frame: Baseline
|
Mean admission Leukocyte Glucose Index value in patients with mild, moderate, and severe diabetic ketoacidosis.
|
Baseline
|
|
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.
|
Baseline
|
|
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.
|
Baseline
|
|
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.
|
Baseline
|
|
Hospital outcomes
Time Frame: Up to 7 days
|
Mean time to DKA resolution (hours) and length of hospital stay (days).
|
Up to 7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Mahmoud M Ashry, prof, Internal Medicine Department, Assiut University Hospitals
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Yu S, Long F, Wei X, Gu H, Hao Z. Myeloid PGGT1B Deficiency Promotes Psoriasiform Dermatitis by Promoting the Secretion of Inflammatory Factors. Int J Mol Sci. 2025 May 20;26(10):4901. doi: 10.3390/ijms26104901.
- Xiong R, Liu A, Xu D, Qu C, Wu Y. A New Heavy-Duty Bearing Degradation Evaluation Method with Multi-Domain Features. Sensors (Basel). 2024 Dec 4;24(23):7769. doi: 10.3390/s24237769.
- Persson J, Steglich B, Smialowska A, Boyd M, Bornholdt J, Andersson R, Schurra C, Arcangioli B, Sandelin A, Nielsen O, Ekwall K. Regulating retrotransposon activity through the use of alternative transcription start sites. EMBO Rep. 2016 May;17(5):753-68. doi: 10.15252/embr.201541866. Epub 2016 Feb 22.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
September 10, 2026
Primary Completion (Estimated)
September 10, 2027
Study Completion (Estimated)
March 1, 2028
Study Registration Dates
First Submitted
September 10, 2026
First Submitted That Met QC Criteria
September 10, 2026
First Posted (Actual)
September 16, 2026
Study Record Updates
Last Update Posted (Actual)
September 16, 2026
Last Update Submitted That Met QC Criteria
September 10, 2026
Last Verified
September 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LGI-DKA-Assiut-2026
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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