Diabetic Kidney Alarm (DKA) Study (DKA)

January 12, 2022 updated by: University of Colorado, Denver

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

41

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80238
        • Children's Hospital Colorado

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proximal tubular dysfunction
Time Frame: At DKA (0-8 and 12-24 hours after starting IV insulin)
Change in urine Na, HCO3 and amino acids concentrations
At DKA (0-8 and 12-24 hours after starting IV insulin)
Proximal tubular injury
Time Frame: At DKA (0-8 and 12-24 hours after starting IV insulin)
Change in urine and serum NGAL, KIM-1 and MMP9 concentrations
At DKA (0-8 and 12-24 hours after starting IV insulin)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proposed mediators of tubular dysfunction and injury
Time Frame: At DKA (0-8 and 12-24 hours after starting IV insulin)
Change in urine uric acid and serum fructose.
At DKA (0-8 and 12-24 hours after starting IV insulin)
Proposed mediators of tubular dysfunction and injury
Time Frame: At DKA (0-8 hours after starting IV insulin)
Presence of urine uric acid crystals by polarized microscopy
At DKA (0-8 hours after starting IV insulin)
Proposed mediators of tubular dysfunction and injury
Time Frame: At DKA (12-24 hours after starting IV insulin)
Presence of urine uric acid crystals by polarized microscopy
At DKA (12-24 hours after starting IV insulin)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

Thrasher Research Fund

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2017

Primary Completion (ACTUAL)

December 13, 2019

Study Completion (ACTUAL)

December 13, 2019

Study Registration Dates

First Submitted

April 13, 2017

First Submitted That Met QC Criteria

April 20, 2017

First Posted (ACTUAL)

April 25, 2017

Study Record Updates

Last Update Posted (ACTUAL)

January 20, 2022

Last Update Submitted That Met QC Criteria

January 12, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-1403

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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