跳至主要内容
临床试验/NCT07821814
NCT07821814尚未招募不适用

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

Assiut University0 个研究点目标入组 120 人开始时间: 2026年9月10日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
120
主要终点
DKA severity according to admission LGI

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • - 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

排除标准

  • - 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

研究组 & 干预措施

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.

结局指标

主要结局

DKA severity according to admission LGI

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

heba helal farag

Resident Physician

Assiut University

相似试验