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Type 1 Diabetes MellitusDKANCT03128229

Diabetic Kidney Alarm (DKA) Study

An observational study of Type 1 Diabetes Mellitus and Diabetic Ketoacidosis, run by University of Colorado, Denver at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The overarching goals of this study are to determine whether tubular dysfunction (elevated urine sodium, bicarbonate and amino acids) and injury (elevated kidney injury molecule 1 [KIM-1], neutrophil gelatinase-associated lipocalin [NGAL] and matrix metallopeptidase 9 [MMP9]) exist in diabetic ketoacidosis (age 3-18)… Read more about this study

Who is it for?
Ages 3 to 18 years
How many people
41 participants
Where
1 siteUnited States
Study dates
1 Jun 2017to 13 Dec 2019
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 3 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Study population: Participants (3-18 years) with T1D presenting with DKA will be recruited from the Emergency Department (ED) at Children's Hospital Colorado.

Who may be able to join

  • New onset T1D and known T1D
  • DKA (mild, moderate and severe DKA eligible)
  • 3-17 years of age
  • Toilet trained
  • Boys and girls
  • All ethnicities
  • Initial presentation to Children's Hospital Colorado (CHCO) Main ED

Who cannot join

  • Non-T1D etiology
  • History of chronic kidney disease (eGFR <60ml/min/1.73m2) or dialysis dependent
  • History of tubulopathy (e.g. Fanconi syndrome)
  • Currently menstruating
  • Patient visiting Colorado with plan to establish diabetes care outside of Colorado
  • On ACE-inhibitors or angiotensin II-receptor blockers (ARB)
  • On sodium-glucose co-transporter 2 inhibitors (SGLT2 inhibitors)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Children's Hospital Colorado

    Aurora, Colorado, 80238

Other trials in United States

About this study

Official title: Diabetic Kidney Alarm (DKA) Study - Tubulopathy in Diabetic Ketoacidosis

The overarching goals of this study are to determine whether tubular dysfunction (elevated urine sodium, bicarbonate and amino acids) and injury (elevated kidney injury molecule 1 [KIM-1], neutrophil gelatinase-associated lipocalin [NGAL] and matrix metallopeptidase 9 [MMP9]) exist in diabetic ketoacidosis (age 3-18), whether it is reversible and whether it is related to uricosuria and copeptin. The investigators propose to study a cohort of youth (ages 3-18, n=40) with T1D who have serum and urine collection at DKA diagnosis and 3-month follow-up.

Read the detailed description

Every year over 86,000 children (0-14 years) worldwide are diagnosed with type 1 diabetes (T1D) translating to a lifetime of exposure and risk for early death from cardiovascular disease (CVD) and diabetic kidney disease (DKD). DKD, which manifests in children and adolescents, remains the leading cause of renal failure and dialysis in the Western world (4). While diabetic glomerulopathy has received significant attention from researchers, determinants of tubular injury in diabetes are less well examined. Compared to glomerular injury, tubular injury is known to associate better with renal function. The majority of youth diagnosed with T1D in the US present with diabetic ketoacidosis (DKA), a condition associated with risks factors for tubular injury including dehydration, metabolic acidosis and acute glycemia. It is unknown whether DKA is associated with tubular injury. The investigators published the first report showing that youth with established T1D have more acidic urine and higher fractional excretion of uric acid (FeUA) than their non-diabetic peers, which may predispose to UUA-mediated tubulopathy. Furthermore, T1D is associated with vasopressin overactivity, and the investigators reported strong relationships between serum copeptin, a reliable surrogate marker for vasopressin, and DKD in T1D. The overarching goals of this study are to determine whether tubular dysfunction (elevated urine sodium, bicarbonate and amino acids) and injury (elevated KIM-1, NGAL and MMP9) exist in DKA, whether it is reversible and whether it is related to uricosuria and copeptin. The investigators propose to study a cohort of youth (ages 3-18, n=40) with T1D who have serum and urine collection at DKA diagnosis and 3-month follow-up.

Medical subject headings
Diabetes Mellitus, Type 1, Diabetic Ketoacidosis

What is being measured

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

  1. Proximal tubular dysfunction

    Change in urine Na, HCO3 and amino acids concentrations

    Measured: At DKA (0-8 and 12-24 hours after starting IV insulin)

  2. Proximal tubular injury

    Change in urine and serum NGAL, KIM-1 and MMP9 concentrations

    Measured: At DKA (0-8 and 12-24 hours after starting IV insulin)

Secondary outcomes (3)

  1. Proposed mediators of tubular dysfunction and injury

    Change in urine uric acid and serum fructose.

    Measured: At DKA (0-8 and 12-24 hours after starting IV insulin)

  2. Proposed mediators of tubular dysfunction and injury

    Presence of urine uric acid crystals by polarized microscopy

    Measured: At DKA (0-8 hours after starting IV insulin)

  3. Proposed mediators of tubular dysfunction and injury

    Presence of urine uric acid crystals by polarized microscopy

    Measured: At DKA (12-24 hours after starting IV insulin)

Timeline

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

  1. First posted25 Apr 2017
  2. Study start1 Jun 2017
  3. Primary completion13 Dec 2019
  4. Study completion13 Dec 2019

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
Cohort
Time perspective
Prospective
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03128229
Sponsor's protocol ID
16-1403
Acronym
DKA
Status last verified
Jan 2022
First submitted
13 Apr 2017
Last updated
20 Jan 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bjornstad P, Johnson RJ, Snell-Bergeon JK, Pyle L, Davis A, Foster N, Cherney DZ, Maahs DM. Albuminuria is associated with greater copeptin concentrations in men with type 1 diabetes: A brief report from the T1D exchange Biobank. J Diabetes Complications. 2017 Feb;31(2):387-389. doi: 10.1016/j.jdiacomp.2016.11.015. Epub 2016 Dec 7.

    PubMed 27979439

  • Bjornstad P, Maahs DM, Jensen T, Lanaspa MA, Johnson RJ, Rewers M, Snell-Bergeon JK. Elevated copeptin is associated with atherosclerosis and diabetic kidney disease in adults with type 1 diabetes. J Diabetes Complications. 2016 Aug;30(6):1093-6. doi: 10.1016/j.jdiacomp.2016.04.012. Epub 2016 Apr 19.

    PubMed 27141815

  • Roncal-Jimenez CA, Milagres T, Andres-Hernando A, Kuwabara M, Jensen T, Song Z, Bjornstad P, Garcia GE, Sato Y, Sanchez-Lozada LG, Lanaspa MA, Johnson RJ. Effects of exogenous desmopressin on a model of heat stress nephropathy in mice. Am J Physiol Renal Physiol. 2017 Mar 1;312(3):F418-F426. doi: 10.1152/ajprenal.00495.2016. Epub 2016 Dec 21.

    PubMed 28003190

  • Bakes K, Haukoos JS, Deakyne SJ, Hopkins E, Easter J, McFann K, Brent A, Rewers A. Effect of Volume of Fluid Resuscitation on Metabolic Normalization in Children Presenting in Diabetic Ketoacidosis: A Randomized Controlled Trial. J Emerg Med. 2016 Apr;50(4):551-9. doi: 10.1016/j.jemermed.2015.12.003. Epub 2016 Jan 25.

    PubMed 26823137

  • Rewers A, Dong F, Slover RH, Klingensmith GJ, Rewers M. Incidence of diabetic ketoacidosis at diagnosis of type 1 diabetes in Colorado youth, 1998-2012. JAMA. 2015 Apr 21;313(15):1570-2. doi: 10.1001/jama.2015.1414. No abstract available.

    PubMed 25898057

  • Dabelea D, Rewers A, Stafford JM, Standiford DA, Lawrence JM, Saydah S, Imperatore G, D'Agostino RB Jr, Mayer-Davis EJ, Pihoker C; SEARCH for Diabetes in Youth Study Group. Trends in the prevalence of ketoacidosis at diabetes diagnosis: the SEARCH for diabetes in youth study. Pediatrics. 2014 Apr;133(4):e938-45. doi: 10.1542/peds.2013-2795. Epub 2014 Mar 31.

    PubMed 24685959

  • Rewers A, Chase HP, Mackenzie T, Walravens P, Roback M, Rewers M, Hamman RF, Klingensmith G. Predictors of acute complications in children with type 1 diabetes. JAMA. 2002 May 15;287(19):2511-8. doi: 10.1001/jama.287.19.2511.

    PubMed 12020331

  • Bjornstad P, Roncal C, Milagres T, Pyle L, Lanaspa MA, Bishop FK, Snell-Bergeon JK, Johnson RJ, Wadwa RP, Maahs DM. Hyperfiltration and uricosuria in adolescents with type 1 diabetes. Pediatr Nephrol. 2016 May;31(5):787-93. doi: 10.1007/s00467-015-3299-8. Epub 2015 Dec 23.

    PubMed 26701836

Questions about this trial

What is this clinical trial studying?

An observational study of Type 1 Diabetes Mellitus and Diabetic Ketoacidosis, run by University of Colorado, Denver at 1 site in United States.

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 7 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 20 Jan 2022. 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 United States. 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?

Proximal tubular dysfunction (time frame: At DKA (0-8 and 12-24 hours after starting IV insulin)). The study lists 2 primary outcomes in all. 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 NCT03128229, which also lists 8 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 20 Jan 2022; AzTrials last refreshed its copy on 28 Oct 2026.

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