Diabetic KetoacidosisNCT06251895
Association of Systemic Immune-inflammation Index and Severity of Diabetic Ketoacidosis in Type 1 Diabetes Mellitus
An observational study of Diabetic Ketoacidosis, run by Jahra Hospital at 1 site in Kuwait.
Trial summary
Diabetic ketoacidosis (DKA) is the most serious metabolic complication of type 1 diabetes mellitus (T1DM). Insulin deficiency and inflammation play a role in the pathogenesis of DKA. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Diabetic Ketoacidosis
- What is being tested?
- DKA protocol
- Type of treatment
- Injection or infusion
- How many people
- 241 participants
- Where
- 1 siteKuwait
- Study dates
- 1 Aug 2021to 11 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Type 1 DM hospitalized because of DKA.
Who may be able to join
- Diagnosis of T1DM
- Hospitalization because of DKA
- Age ≥ 12 years.
Who cannot join
- Diagnosis of T2DM
- Diagnosis of Infection
- Renal impairment
- Malignancy
- ASCVD (atherosclerotic cardiovascular disease)
- History of any medical condition or medications that can change CBC parameters or cause metabolic acidosis
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association of the Systemic Immune-inflammation Index (SII) and Severity of Diabetic Ketoacidosis in Patients With Type 1 Diabetes Mellitus: A Retrospective Cohort Study
Diabetic ketoacidosis (DKA) is the most serious metabolic complication of type 1 diabetes mellitus (T1DM). Insulin deficiency and inflammation play a role in the pathogenesis of DKA. The investigators aim to assess the systemic immune-inflammation index (SII) as a marker of severity among T1DM patients with DKA and without infection.
Read the detailed description
Diabetic ketoacidosis (DKA) is one of the most severe acute metabolic complications of diabetes mellitus (DM). Therefore, DKA patients require prompt treatment and any delay in identifying severe DKA cases can lead to worse outcomes. DKA provokes a systemic inflammatory response through increased levels of various cytokines such as interleukin (IL)-8, IL-6, IL-10, tumor necrosis factor-alpha (TNF-α), and IL-1B. This will lead to cellular activation, cellular adhesion, increased oxidative stress, and endothelial damage, possibly contributing to complications. Consequently, surrogate markers of inflammation and immune status may help in the early identification of patients with severe DKA.
The systemic immune-inflammation index (SII) had a better prognostic value compared to NLR and PLR among cancer patients. Recently, studies have suggested a link between SII and increased risk of atherosclerotic cardiovascular disease (ASCVD), hepatic steatosis, and worse outcomes among hypertensive patients and patients with stroke.
Therefore, the investigators aim to examine SII as a marker of severity in T1DM patients with DKA in an uninfected state.
- Conditions
- Diabetic Ketoacidosis
- Being tested
- DKA protocol
- Keywords
- Complete blood count, diabetes mellitus, diabetic ketoacidosis, systemic immune inflammation index.
- 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.
DKA protocolOther
IV fluids and IV insulin as per guidelines. reference 1-2
| Study group | Role | What they receive |
|---|---|---|
| mild DKA | pH < 7.3 or serum bicarbonate <18 mmol/L Receives: Other: DKA protocol | |
| moderate DKA | pH < 7.2 or serum bicarbonate <10 mmol/L Receives: Other: DKA protocol | |
| severe DKA | pH < 7.1 or serum bicarbonate <5 mmol/L Receives: Other: DKA protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
SII
SII = (neutrophil × platelet) / lymphocyte.
Measured: Day 1 (baseline)
Secondary outcomes (2)
ICU admission
need for ICU admission
Measured: Hospital stay up to one week
readmission
readmission because of DKA
Measured: within 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start1 Aug 2021
- Primary completion31 Dec 2022
- Study completion11 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetic KetoacidosisStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jahra Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Aon, Jahra Hospital
- Investigators
- MOHAMED AON, PHD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06251895
- Sponsor's protocol ID
- J1 - 18072023
- Status last verified
- Feb 2024
- First submitted
- 23 Jan 2024
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Datasets analyzed during the current study will be available upon reasonable request from the corresponding author and after IRB approval.
Publications
Dhatariya KK; Joint British Diabetes Societies for Inpatient Care. The management of diabetic ketoacidosis in adults-An updated guideline from the Joint British Diabetes Society for Inpatient Care. Diabet Med. 2022 Jun;39(6):e14788. doi: 10.1111/dme.14788. Epub 2022 Feb 27.
PubMed 35224769Glaser N, Fritsch M, Priyambada L, Rewers A, Cherubini V, Estrada S, Wolfsdorf JI, Codner E. ISPAD clinical practice consensus guidelines 2022: Diabetic ketoacidosis and hyperglycemic hyperosmolar state. Pediatr Diabetes. 2022 Nov;23(7):835-856. doi: 10.1111/pedi.13406. No abstract available.
PubMed 36250645
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of the Systemic Immune-inflammation Index (SII) and Severity of Diabetic Ketoacidosis in Patients With Type 1 Diabetes Mellitus: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06251895
- Acronym / sponsor ID
- J1 - 18072023
- Conditions
- Diabetic Ketoacidosis
- Keywords
- Complete blood count, diabetes mellitus, diabetic ketoacidosis, systemic immune inflammation index.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- Jahra HospitalUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 11 Nov 2023 (actual)
- First posted
- 9 Feb 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.
Diabetic ketoacidosis (DKA) is the most serious metabolic complication of type 1 diabetes mellitus (T1DM). Insulin deficiency and inflammation play a role in the pathogenesis of DKA. The investigators aim to assess the systemic immune-inflammation index (SII) as a marker of severity among T1DM patients with DKA and without infection.
Detailed description
Diabetic ketoacidosis (DKA) is one of the most severe acute metabolic complications of diabetes mellitus (DM). Therefore, DKA patients require prompt treatment and any delay in identifying severe DKA cases can lead to worse outcomes. DKA provokes a systemic inflammatory response through increased levels of various cytokines such as interleukin (IL)-8, IL-6, IL-10, tumor necrosis factor-alpha (TNF-α), and IL-1B. This will lead to cellular activation, cellular adhesion, increased oxidative stress, and endothelial damage, possibly contributing to complications. Consequently, surrogate markers of inflammation and immune status may help in the early identification of patients with severe DKA.
The systemic immune-inflammation index (SII) had a better prognostic value compared to NLR and PLR among cancer patients. Recently, studies have suggested a link between SII and increased risk of atherosclerotic cardiovascular disease (ASCVD), hepatic steatosis, and worse outcomes among hypertensive patients and patients with stroke.
Therefore, the investigators aim to examine SII as a marker of severity in T1DM patients with DKA in an uninfected state.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| mild DKA | – | Other: DKA protocolpH < 7.3 or serum bicarbonate <18 mmol/L |
| moderate DKA | – | Other: DKA protocolpH < 7.2 or serum bicarbonate <10 mmol/L |
| severe DKA | – | Other: DKA protocolpH < 7.1 or serum bicarbonate <5 mmol/L |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Type 1 DM hospitalized because of DKA.
Key inclusion criteria (3 listed)
- Diagnosis of T1DM
- Hospitalization because of DKA
- Age ≥ 12 years.
Key exclusion criteria (7 listed)
- Diagnosis of T2DM
- Diagnosis of Infection
- Renal impairment
- Malignancy
- ASCVD (atherosclerotic cardiovascular disease)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DKA protocolIV fluids and IV insulin as per guidelines. reference 1-2 | Other | mild DKA, moderate DKA, severe DKA |
Primary outcome
SII
Time frame: Day 1 (baseline)
SII = (neutrophil × platelet) / lymphocyte.
2 secondary outcomes
ICU admission
Time frame: Hospital stay up to one week
readmission
Time frame: within 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
- Background: PubMed 35224769Dhatariya KK; Joint British Diabetes Societies for Inpatient Care. The management of diabetic ketoacidosis in adults-An updated guideline from the Joint British Diabetes Society for Inpatient Care. Diabet Med. 2022 Jun;39(6):e14788. doi: 10.1111/dme.14788. Epub 2022 Feb 27.
- Background: PubMed 36250645Glaser N, Fritsch M, Priyambada L, Rewers A, Cherubini V, Estrada S, Wolfsdorf JI, Codner E. ISPAD clinical practice consensus guidelines 2022: Diabetic ketoacidosis and hyperglycemic hyperosmolar state. Pediatr Diabetes. 2022 Nov;23(7):835-856. doi: 10.1111/pedi.13406. No abstract available.
- Individual participant dataSharing planned: Undecided. Datasets analyzed during the current study will be available upon reasonable request from the corresponding author and after IRB approval.
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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. This study is not recruiting at the moment.
MOHAMED AON, PHD principal investigator
Cairo University
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 Jahra Hospital at 1 site in Kuwait.
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 3 inclusion and 7 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: finished, as of the sponsor's last update on 9 Feb 2024. 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 Kuwait. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SII (time frame: Day 1 (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 NCT06251895, which also lists 2 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 9 Feb 2024.