Elevated Leukocyte Glucose Index (LGI) and Severity of Diabetic Ketoacidosis and Microvascular Complications
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Assiut University
- Enrollment
- 120
- Primary Endpoint
- DKA severity according to admission LGI
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Outcomes
Primary Outcomes
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
- Mean LGI according to DKA severity(Baseline)
- Prevalence of microvascular complications according to LGI(Baseline)
- Correlation of LGI with biochemical severity markers(Baseline)
- Discriminatory performance of LGI for severe DKA(Baseline)
- Hospital outcomes(Up to 7 days)
Investigators
heba helal farag
Resident Physician
Assiut University