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Copeptin in Adolescent Participants With Type 1 Diabetes and Early Renal Hemodynamic Function (CASPER)

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ClinicalTrials.gov Identifier: NCT03618420
Recruitment Status : Completed
First Posted : August 7, 2018
Results First Posted : August 31, 2021
Last Update Posted : August 31, 2021
Sponsor:
Information provided by (Responsible Party):
Petter Bjornstad, University of Colorado, Denver

Tracking Information
First Submitted Date  ICMJE August 1, 2018
First Posted Date  ICMJE August 7, 2018
Results First Submitted Date  ICMJE August 5, 2021
Results First Posted Date  ICMJE August 31, 2021
Last Update Posted Date August 31, 2021
Actual Study Start Date  ICMJE October 1, 2018
Actual Primary Completion Date October 19, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 5, 2021)
  • Copeptin Levels [ Time Frame: 4 hours ]
    Measured by fasting blood draw
  • Effective Renal Plasma Flow (ERPF) [ Time Frame: 4 hours ]
    Measured by PAH clearance
  • Glomerular Filtration Rate (GFR) [ Time Frame: 4 hours ]
    Measured by iohexol clearance
Original Primary Outcome Measures  ICMJE
 (submitted: August 1, 2018)
  • Copeptin levels [ Time Frame: 4 hours ]
    Measured by fasting blood draw
  • Effective Renal Plasma Flow (ERPF) [ Time Frame: 4 hours ]
    Measured by PAH clearance
  • Glomerular Filtration Rate (GFR) [ Time Frame: 4 hours ]
    Measured by Ioxhexal clearance
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 1, 2018)
  • Renal Perfusion [ Time Frame: 10 min ]
    Measured by Arterial Spin Labeling (ASL) MRI
  • Renal Oxygenation [ Time Frame: 60 min ]
    Measured by Blood Oxygen Level Dependent (BOLD) MRI
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Copeptin in Adolescent Participants With Type 1 Diabetes and Early Renal Hemodynamic Function
Official Title  ICMJE CASPER Study: Copeptin in Adolescent Participants With Type 1 Diabetes and Early Renal Hemodynamic Function
Brief Summary

Over 1.25 million Americans have type 1 diabetes (T1D), increasing risk for early death from cardiorenal disease. The strongest risk factor for cardiovascular disease (CVD) and mortality in T1D is diabetic kidney disease (DKD). Current treatments, such as control of hyperglycemia and hypertension, are beneficial, but only partially protect against DKD.

Hyperfiltration is common in youth with T1D, and predicts progressive DKD. Hyperfiltration is also associated with early changes in intrarenal hemodynamic function, including increased renal plasma flow (RPF) and glomerular pressure. Intrarenal hemodynamic function is strongly influenced by the renin-angiotensin-aldosterone system (RAAS), which is also considered a key player in the pathogenesis of DKD. Preliminary data demonstrate differences in intrarenal hemodynamic function and RAAS activation in early and advanced DKD in T1D. However, the pathophysiology contributing to the differences observed in RAAS activation and intrarenal hemodynamic function in T1D are poorly defined Animal research demonstrates that arginine vasopressin (AVP) acts directly to modify intrarenal hemodynamic function, but also indirectly by activating RAAS. Preliminary data suggest that elevated copeptin, a marker of AVP, which predicts DKD in T1D adults, independently of other risk factors. However, no human studies to date have examined how copeptin relates to intrarenal hemodynamic function in early DKD in T1D. A better understanding of this relationship is critical to inform development of new therapies targeting the AVP system in T1D. Accordingly, in this study, the investigators propose to define the relationship between copeptin and intrarenal hemodynamics in early stages of DKD, by studying copeptin levels, renal plasma flow, and glomerular filtration in youth (n=50) aged 12-21 y with T1D duration < 10 y.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
All study participants will receive the same intervention.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Diabetes Mellitus, Type 1
  • Nephropathy
  • Diabetic Nephropathies
  • Juvenile Diabetes
  • Diabetes Mellitus Complication
  • Autoimmune Diabetes
  • Type 1 Diabetes Mellitus
Intervention  ICMJE
  • Drug: Aminohippurate Sodium Inj 20%
    Diagnostic aid/agent used to measure effective renal plasma flow (ERPF)
    Other Names:
    • Aminohippuric acid
    • Para-aminohippurate
    • Sodium 4-amino hippurate (PAH) inj 20% 2g/10 mL
  • Drug: Iohexol Inj 300 mg/mL
    Diagnostic aid/agent used to measure glomerular filtration rate (GFR)
    Other Name: omnipaque 300
Study Arms  ICMJE Clinical Investigation
All participants will undergo assessment of Glomerular Filtration Rate, (Iohexol Inj 300 mg/mL) and Effective Renal Plasma Flow (Aminohippurate Sodium Inj 20%). In addition, participants will undergo imaging assessment that includes Dual X-Ray Absorptiometry (DXA), renal Blood Oxygen Level Dependent (BOLD) and Arterial Spin Labeling (ASL) MRI.
Interventions:
  • Drug: Aminohippurate Sodium Inj 20%
  • Drug: Iohexol Inj 300 mg/mL
Publications * Vinovskis C, Li LP, Prasad P, Tommerdahl K, Pyle L, Nelson RG, Pavkov ME, van Raalte D, Rewers M, Pragnell M, Mahmud FH, Cherney DZ, Johnson RJ, Nadeau KJ, Bjornstad P. Relative Hypoxia and Early Diabetic Kidney Disease in Type 1 Diabetes. Diabetes. 2020 Dec;69(12):2700-2708. doi: 10.2337/db20-0457. Epub 2020 Jul 31.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 1, 2018)
50
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 1, 2021
Actual Primary Completion Date October 19, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Antibody+ T1D with <10 yr duration
  • Age 12-21 years
  • BMI ≥ 5%ile
  • Weight<350 lbs and > 57 lbs.
  • No anemia
  • HbA1c <12%

Exclusion Criteria:

  • Severe illness, recent diabetic ketoacidosis (DKA)
  • Estimated Glomerular Filtration Rate (eGFR) <60ml/min/1.73m2 or creatinine > 1.5mg/dl or history of ACR≥300mg/g
  • Anemia or allergy to shellfish or iodine
  • Pregnancy or nursing
  • MRI scanning contraindications (claustrophobia, implantable devices, >350 lbs)
  • Angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARB), diuretics, sodium-glucose co-transport (SGLT) 2 or 1 blockers, daily NSAIDs or aspirin, sulfonamides, procaine, thiazolsulfone or probenecid, atypical antipsychotics and steroids
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03618420
Other Study ID Numbers  ICMJE 17-0820
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Petter Bjornstad, University of Colorado, Denver
Study Sponsor  ICMJE University of Colorado Denver School of Medicine Barbara Davis Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Petter Bjornstad, MD University of Colorado School of Medicine
PRS Account University of Colorado Denver School of Medicine Barbara Davis Center
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP