Diabetic KetoacidosisNCT07821814
Leukocyte Glucose Index and Severity of Diabetic Ketoacidosis
An observational study of Diabetic Ketoacidosis and Diabetes Mellitus, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Ketoacidosis, Diabetes Mellitus
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 10 Sep 2026to 1 Mar 2028
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients presenting with diabetic ketoacidosis to the Internal Medicine Department and Emergency Department of Assiut University Hospitals.
Who may be able to join
- - 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
Who cannot join
- - 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetic Ketoacidosis, Diabetes Mellitus
- Keywords
- Leukocyte Glucose Index, Diabetic ketoacidosis, LGI, DKA severity, Microvascular complications
- Medical subject headings
- Diabetic Ketoacidosis, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (5)
Mean LGI according to DKA severity
Mean admission Leukocyte Glucose Index value in patients with mild, moderate, and severe diabetic ketoacidosis.
Measured: Baseline
Prevalence of microvascular complications according to LGI
Proportion of patients with diabetic nephropathy, retinopathy, or peripheral neuropathy according to admission LGI categories.
Measured: Baseline
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.
Measured: Baseline
Discriminatory performance of LGI for severe DKA
Area under the ROC curve, sensitivity, and specificity of admission LGI for identifying severe diabetic ketoacidosis.
Measured: Baseline
Hospital outcomes
Mean time to DKA resolution (hours) and length of hospital stay (days).
Measured: Up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start10 Sep 2026 (estimated)
- Primary completion10 Sep 2027 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetic KetoacidosisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, heba helal farag, Assiut University
- Investigators
- Mahmoud M Ashry, prof, Study chair, Internal Medicine Department, Assiut University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07821814
- Sponsor's protocol ID
- LGI-DKA-Assiut-2026
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 40430037Xiong 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.
PubMed 39686307Persson 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.
PubMed 26902262
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elevated Leukocyte Glucose Index (LGI) and Severity of Diabetic Ketoacidosis and Microvascular Complications
- ClinicalTrials.gov ID
- NCT07821814
- Acronym / sponsor ID
- LGI-DKA-Assiut-2026
- Conditions
- Diabetic Ketoacidosis, Diabetes Mellitus
- Keywords
- Leukocyte Glucose Index, Diabetic ketoacidosis, LGI, DKA severity, Microvascular complications
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Sep 2026 (estimated)
- Primary completion
- 10 Sep 2027 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 16 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients presenting with diabetic ketoacidosis to the Internal Medicine Department and Emergency Department of Assiut University Hospitals.
Key inclusion criteria (4 listed)
- - 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
Key exclusion criteria (8 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
5 secondary outcomes
Mean LGI according to DKA severity
Time frame: Baseline
Prevalence of microvascular complications according to LGI
Time frame: Baseline
Correlation of LGI with biochemical severity markers
Time frame: Baseline
Discriminatory performance of LGI for severe DKA
Time frame: Baseline
Hospital outcomes
Time frame: Up to 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Background: PubMed 40430037Yu 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.
- Background: PubMed 39686307Xiong 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.
- Background: PubMed 26902262Persson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mahmoud M Ashry, prof study chair
Internal Medicine Department, Assiut University Hospitals
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Ketoacidosis and Diabetes Mellitus, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heba H farag, Resident (01110892460, Heba.17289965@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DKA severity according to admission LGI (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07821814, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.