NCT07821814

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
17mo left

Started Sep 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress5%
Sep 2026Mar 2028

First Submitted

Initial submission to the registry

September 10, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

September 10, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 16, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

September 16, 2026

Status Verified

September 1, 2026

Enrollment Period

1 year

First QC Date

September 10, 2026

Last Update Submit

September 10, 2026

Conditions

Diabetic KetoacidosisDiabetes Mellitus

Keywords

Leukocyte Glucose IndexDiabetic ketoacidosisLGIDKA severityMicrovascular complications

Outcome Measures

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.

    Baseline

Secondary Outcomes (5)

  • 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

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • \- 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

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 40430037BACKGROUND

  • 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.

    PMID: 39686307BACKGROUND

  • 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.

    PMID: 26902262BACKGROUND

MeSH Terms

Conditions

Diabetic KetoacidosisDiabetes Mellitus

Condition Hierarchy (Ancestors)

KetosisAcidosisAcid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesDiabetes ComplicationsEndocrine System DiseasesGlucose Metabolism Disorders

Study Officials

  • Mahmoud M Ashry, prof

    Internal Medicine Department, Assiut University Hospitals

    STUDY CHAIR

Central Study Contacts

Heba H farag, Resident

CONTACT

01110892460Heba.17289965@med.aun.edu.eg

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
7 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Physician

Study Record Dates

First Submitted

September 10, 2026

First Posted

September 16, 2026

Study Start

September 10, 2026

Primary Completion (Estimated)

September 10, 2027

Study Completion (Estimated)

March 1, 2028

Last Updated

September 16, 2026

Record last verified: 2026-09