Health TrialsbyHealthPanel

Leukocyte Glucose Index and Severity of Diabetic Ketoacidosis

ConditionsDiabetic KetoacidosisDiabetes Mellitus
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssiut University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

- 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

Disqualifiers

- 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

Trial population

Adult patients presenting with diabetic ketoacidosis to the Internal Medicine Department and Emergency Department of Assiut University Hospitals.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

120 Participants
are grouped into 1 trial group
Group A: Single cohort: Adults with diabetic ketoacidosis

Trial outcomes

Primary outcomes

1

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

1

Mean LGI according to DKA severity

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

Time frame
Baseline
2

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
3

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
4

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assiut University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: