Diabetic KetoacidosisNCT06748365
Serum Ferritin and Prognosis of DKA
An observational study of Diabetic Ketoacidosis, run by Sohag University at 1 site in Egypt.
Trial summary
the aim of this study is to: evaluate the association between serum ferritin levels and the clinical presentation and short-term prognosis of patients with DKA. Specifically, the correlation between its level and the severity of DKA at presentation and determine its prognostic value in predicting short-term outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Ketoacidosis
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2025to Feb 2026
- 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: Patients diagnosed with DKA admitted to the emergency department or intensive care units of Sohag university Hospital
Who may be able to join
- -
- All patients with DKA :
- Adult Aged 18 years old or older .
- Type 1 DM , type 2 DM
- Diagnosis of DKA based on the American Diabetes Association criteria: blood glucose >250 mg/dL, arterial pH <7.3, serum bicarbonate <18 mEq/L,
Who cannot join
- Patients age less than 18 years old
- Iron deficiency anemia and iron overload
- Chronic Inflammatory Diseases: Conditions such as rheumatoid arthritis, systemic lupus erythematosus, and inflammatory bowel disease
- Acute and chronic infections, including bacterial, viral, and fungal infections
- Pt presented with other acute complication (MI,stroke)
- CKD patients
Show all 9Show fewer
- Patients with chronic liver diseases
- Patients with malignancy
- Pregnant women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Sohag university Hospitals
Sohag, Sohag Governorate, 82524
About this study
Official title: Role of Ferritin in the Clinical Presentation and Short-Term Prognosis of Diabetic Ketoacidosis
the aim of this study is to: evaluate the association between serum ferritin levels and the clinical presentation and short-term prognosis of patients with DKA. Specifically, the correlation between its level and the severity of DKA at presentation and determine its prognostic value in predicting short-term outcomes.
Read the detailed description
Ferritin studies and correlation to acute events like stroke or Mi was done before, however some studies have found a correlation with the degree and prognosis of these diseases and others not. However no study was tried on DKA patients before so the investigators are trying to find if Ferritin would have a relation with patients of Dka and could be used as a prognostic tool (for example we found in this study when level is less than "200" patients mostly has good prognosis) this is just an example or (serrum ferritin turned out to be irrelevant to DKA prognosis as patients would have good prognosis despite number value) and this will be in selected patients according to criteria to exclude any chronic condition in the investigators hospital care units.
- Conditions
- Diabetic Ketoacidosis
- Keywords
- serum Ferritin, Diabetic Ketoacidosis
- Medical subject headings
- Diabetic Ketoacidosis
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate the association between serum ferritin levels and the clinical presentation and short-term prognosis of patients with DKA. Specifically, the correlation between its level and the severity of DKA at presentation and determine its prognostic value
Measured: Through the study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start1 Jan 2025
- Primary completionJan 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic KetoacidosisStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Medhat Sobhy, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06748365
- Sponsor's protocol ID
- Soh-Med--24-12-07MS
- Status last verified
- Dec 2024
- First submitted
- 18 Dec 2024
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Ferritin in the Clinical Presentation and Short-Term Prognosis of Diabetic Ketoacidosis
- ClinicalTrials.gov ID
- NCT06748365
- Acronym / sponsor ID
- Soh-Med--24-12-07MS
- Conditions
- Diabetic Ketoacidosis
- Keywords
- serum Ferritin, Diabetic Ketoacidosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 27 Dec 2024 (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.
the aim of this study is to: evaluate the association between serum ferritin levels and the clinical presentation and short-term prognosis of patients with DKA. Specifically, the correlation between its level and the severity of DKA at presentation and determine its prognostic value in predicting short-term outcomes.
Detailed description
Ferritin studies and correlation to acute events like stroke or Mi was done before, however some studies have found a correlation with the degree and prognosis of these diseases and others not. However no study was tried on DKA patients before so the investigators are trying to find if Ferritin would have a relation with patients of Dka and could be used as a prognostic tool (for example we found in this study when level is less than "200" patients mostly has good prognosis) this is just an example or (serrum ferritin turned out to be irrelevant to DKA prognosis as patients would have good prognosis despite number value) and this will be in selected patients according to criteria to exclude any chronic condition in the investigators hospital care units.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with DKA admitted to the emergency department or intensive care units of Sohag university Hospital
Key inclusion criteria (5 listed)
- -
- Adult Aged 18 years old or older .
- Type 1 DM , type 2 DM
- Diagnosis of DKA based on the American Diabetes Association criteria: blood glucose >250 mg/dL, arterial pH <7.3, serum bicarbonate <18 mEq/L,
Key exclusion criteria (9 listed)
- Patients age less than 18 years old
- Iron deficiency anemia and iron overload
- Chronic Inflammatory Diseases: Conditions such as rheumatoid arthritis, systemic lupus erythematosus, and inflammatory bowel disease
- Acute and chronic infections, including bacterial, viral, and fungal infections
- Pt presented with other acute complication (MI,stroke)
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
evaluate the association between serum ferritin levels and the clinical presentation and short-term prognosis of patients with DKA. Specifically, the correlation between its level and the severity of DKA at presentation and determine its prognostic value
Time frame: Through the study completion, an average of 1 year
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 14 May 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Diabetic Ketoacidosis
Not yet recruitingPhase 1/2
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PAL-119 in Healthy Volunteers and Adult Participants With Type 1 or Type 2 Diabetes
Healthy Volunteers and Diabetes Participants
Not yet recruitingPhase 2
Mitigating DKA in Type 1 Diabetes for Safe Use of SGLT Inhibitors Using Dual Continuous Ketone and Glucose Monitoring.
Type 1 Diabetes Mellitus, Chronic Kidney Disease (CKD) With Diabetes Mellitus (DM)
RecruitingObservational study
The Real-World Control-IQ Glycemic Control and Quality of Life Study in Type 1 Diabetes in France
Diabetes Mellitus, Type 1
RecruitingObservational study
Perfusion Index for Predicting Diabetic Ketoacidosis Severity in the Emergency Department
Diabetic Ketoacidosis
Not yet recruitingObservational study
Leukocyte Glucose Index and Severity of Diabetic Ketoacidosis
Diabetic Ketoacidosis, Diabetes Mellitus
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Ketoacidosis, run by Sohag University at 1 site in Egypt.
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 5 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Joseph Medhat Sobhy, resident in internal medicine (+2001011041077, joeisgreatyeah@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluate the association between serum ferritin levels and the clinical presentation and short-term prognosis of patients with DKA. Specifically, the correlation between its level and the severity of DKA at presentation and determine its prognostic value (time frame: Through the study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 May 2025.