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Diabetes MellitiusAKINCT06032325

Neutrophil Gelatinase Associated Lipocalin and Kidney Injury Molecule-1 As Biomarkers of AKI in Children With DKA

An observational study of Diabetes Mellitius, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Type 1 diabetes mellitus (T1DM) is a common, chronic, metabolic disorder that has significant consequences for physical and emotional development . The incidence of TIDM is steadily increasing in nearly all parts of the world by about 2-5% per year . Read more about this study

Who is it for?
Ages 1 year to 18 years
Conditions the study is for
Diabetes Mellitius
What is being tested?
Neutrophil Gelatinase and Kidney Injury Molecule-1
How many people
48 participants
Where
No sites listed yet
Study dates
1 Jan 2024to 1 Dec 2024
How long will I take part?
1 Month
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 1 year to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Study population: - All patients with diabetic ketoacidosis below 18 years

Who may be able to join

  • All patients with diabetic ketoacidosis below 18 years whether first time or recurrent ketoacidosis with either increase in serum creatinine more than or equal 0.3 mg/dl within 48hrs or to more than or equal 1.5 times or more baseline within 7 days or urine output less than 0.5 mL/kg/h for 6 hours.(22)

Who cannot join

  • Patients with known renal disease before first attack of diabetic ketoacidosis

About this study

Official title: Neutrophil Gelatinase Associated Lipocalin and Kidney Injury Molecule-1 As Biomarkers of Acute Kidney Injury in Children With Diabetic Ketoacidosis

Type 1 diabetes mellitus (T1DM) is a common, chronic, metabolic disorder that has significant consequences for physical and emotional development . The incidence of TIDM is steadily increasing in nearly all parts of the world by about 2-5% per year . Diabetic ketoacidosis (DKA) is the most serious complication of TIDM and results from metabolic abnormalities due to a severe deficiency of insulin or insulin effectiveness. Similar to diabetes, DKA has an increasing incidence and more frequently occurs in children.

DKA occurs in 20-40% of children with new-onset diabetes and in children with known diabetes who omit insulin doses or who do not successfully manage during intercurrent illness (1). Although the inpatient mortality rates of DKA are generally very low (5, 6) ,DKA is the leading with TIDM (7). DKA is associated with numerous acid-base, hydration and electrolyte derangements. Accompanied by both volume depletion and subsequent massive fluid-rehydration treatment upon presentation, children with DKA potentially have a high risk for acute kidney injury (AKI). For decades, nonconsensual definitions of AKI were used, making it difficult to obtain an accurate evaluation of the epidemiological studies

Read the detailed description

Type 1 diabetes mellitus (T1DM) is a common, chronic, metabolic disorder that has significant consequences for physical and emotional development. The incidence of TIDM is steadily increasing in nearly all parts of the world by about 2-5% per year. Diabetic ketoacidosis (DKA) is the most serious complication of TIDM and results from metabolic abnormalities due to a severe deficiency of insulin or insulin effectiveness. Similar to diabetes, DKA has an increasing incidence and more frequently occurs in children .

DKA occurs in 20-40% of children with new-onset diabetes and in children with known diabetes who omit insulin doses or who do not successfully manage during intercurrent illness . Although the inpatient mortality rates of DKA are generally very low ,DKA is the leading with TIDM. DKA is associated with numerous acid-base, hydration and electrolyte derangements. Accompanied by both volume depletion and subsequent massive fluid-rehydration treatment upon presentation, children with DKA potentially have a high risk for acute kidney injury (AKI). For decades, nonconsensual definitions of AKI were used, making it difficult to obtain an accurate evaluation of the epidemiological studies During the last decade, three definitions of AKI have been developed, and it is now possible to identify patients at high risk of AKI. A recent study revealed that a high proportion of children with DKA develop AKI. However, AKI remains poorly reported in children with DKA . Therefore, this study aimed to investigate the clinical characteristics and risk factors for AKI in children with DKA, and to find the risk factors of AKI on admission.

Diabetic kidney disease (DKD) is the leading cause of end-stage kidneydisease (ESKD) and dialysis in the developed world. DKD is characterizednot only by glomerular disease but also tubulointerstitial injury with tubular basement membrane thickening, tubular hypertrophy,epithelial-mesenchymal transition, glycogen accumulation andinterstitial inflammation. Although glomerular changes in diabeteshave received significant attention from researchers and clinicians,tubulointerstitial injury is known to better associate with kidney dysfunction. In fact, tubular proteinuria may precede microalbuminuriain type 1 diabetes (T1D), suggesting that tubular damage may be anearly injury pattern of DKD.4 High glucose states, such as DKA, havebeen shown to induce proximal tubular degeneration and interstitialfibrosis in both mice and humans.

More than one third of T1D youth enrolled in the SEARCH forDiabetes in Youth study had diabetic ketoacidosis (DKA) at diagnosisand in another Colorado-based study, about 55% of youth with newdiagnosis of T1D presented with DKA, which is more frequent thanwhat has been reported in international registries. Although acutekidney injury (AKI) secondary to dehydration is a well-recognizedcomplication of DKA, tubular injury attributed to DKA is poorlydescribed.5 Pathophysiologic pathways in early DKD are thought toinvolve elevated serum uric acid (SUA) and vasopressin, which are also implicated in DKA. Indeed, elevated SUA and vasopressin concentrationshave both shown to induce tubulointerstitial injury.

If DKA at diagnosis of T1D in youth is associated withtubulopathy, interventions that preserve tubular health may mitigatekidney damage. Targeted early interventions are especially importantas development of tubular injury may confer increased risk of chronickidney disease (CKD) and ESKD in the setting of DKA and AKI.

Accordingly, our study sought to assess the extent of tubular injury in DKA by characterizing the trajectories of tubular injury biomarkersover 3 months in youth with T1D diagnosed with DKA and to examinethe relationship of vasopressin and SUA in the hypothesized tubularinjury. Acute kidney injury is usually diagnosed with serialmeasurements of creatinine, cystatin C and estimated glomerular filtrationrate (eGFR) Since these parameters are influenced by iatrogenicfactors relevant to DKA care (e.g., intravenous hydration andinsulin) and are not specific for tubulointerstitial injury, we also measuredthe following tubular injury markers: neutrophil gelatinaseassociatedlipocalin (NGAL), kidney injury molecule 1 (KIM-1),chitinase 3-like 1 (YKL-40), interleukin 18 (IL-18), and monocytechemoattractant protein-1 (MCP-1).

Being tested
Neutrophil Gelatinase and Kidney Injury Molecule-1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neutrophil Gelatinase and Kidney Injury Molecule-1Diagnostic test

    To assess Neutrophil Gelatinase associated Lipocalin and Kidney Injury Molecule-1 as biomarkers of acute kidney injury in children with Diabetic Ketoacidosis

Study groups in NCT06032325
Study groupRoleWhat they receive
Neutrophil Gelatinase Associated Lipocalin and Kidney Injury Molecule-1Not described
Receives: Diagnostic Test: Neutrophil Gelatinase and Kidney Injury Molecule-1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. biomarkers

    To assess Neutrophil Gelatinase associated Lipocalin and Kidney Injury Molecule-1 as biomarkers of acute kidney injury in children with Diabetic Ketoacidosis

    Measured: 1 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2023
  2. Study start1 Jan 2024 (estimated)
  3. Primary completion1 Dec 2024 (estimated)
  4. Study completion1 Dec 2024 (estimated)

Resources

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
Other
Time perspective
Prospective
Enrolment
48 participants (estimated)
Target duration
1 Month
IDs, dates and publications
ClinicalTrials.gov ID
NCT06032325
Sponsor's protocol ID
1010
Acronym
AKI
Status last verified
Sep 2023
First submitted
22 Jul 2023
Last updated
13 Sep 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Neutrophil Gelatinase Associated Lipocalin and Kidney Injury Molecule-1 As Biomarkers of AKI in Children With DKA

Publications

  • Bjornstad P, Lanaspa MA, Ishimoto T, Kosugi T, Kume S, Jalal D, Maahs DM, Snell-Bergeon JK, Johnson RJ, Nakagawa T. Fructose and uric acid in diabetic nephropathy. Diabetologia. 2015 Sep;58(9):1993-2002. doi: 10.1007/s00125-015-3650-4. Epub 2015 Jun 7.

    PubMed 26049401

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitius, 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 13 Sep 2023. 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?

Results are not available in the source record.

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?

biomarkers (time frame: 1 years). 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 NCT06032325, which also lists 1 linked publication.

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 13 Sep 2023.

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