Ignite Creation Date:
2024-05-06 @ 9:58 AM
Last Modification Date:
2024-10-26 @ 12:22 PM
Study NCT ID:
NCT03128229
Status:
COMPLETED
Last Update Posted:
2022-01-20
First Post:
2017-04-13
Brief Title:
Diabetic Kidney Alarm DKA Study
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
Diabetic Kidney Alarm DKA Study - Tubulopathy in Diabetic Ketoacidosis
Status:
COMPLETED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DKA
Brief 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 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 n40 with T1D who have serum and urine collection at DKA diagnosis and 3-month follow-up
Detailed Description:
Every year over 86000 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 n40 with T1D who have serum and urine collection at DKA diagnosis and 3-month follow-up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None