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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 : Recruiting
First Posted : August 7, 2018
Last Update Posted : October 19, 2018
Sponsor:
Information provided by (Responsible Party):
Petter Bjornstad, University of Colorado, Denver

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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Nephropathy Diabetic Nephropathies Juvenile Diabetes Diabetes Mellitus Complication Autoimmune Diabetes Type 1 Diabetes Mellitus Drug: Aminohippurate Sodium Inj 20% Drug: Iohexol Inj 300 mg/mL Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Intervention Model Description: All study participants will receive the same intervention.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: CASPER Study: Copeptin in Adolescent Participants With Type 1 Diabetes and Early Renal Hemodynamic Function
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Iohexol

Arm Intervention/treatment
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.
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




Primary Outcome Measures :
  1. Copeptin levels [ Time Frame: 4 hours ]
    Measured by fasting blood draw

  2. Effective Renal Plasma Flow (ERPF) [ Time Frame: 4 hours ]
    Measured by PAH clearance

  3. Glomerular Filtration Rate (GFR) [ Time Frame: 4 hours ]
    Measured by iohexol clearance


Secondary Outcome Measures :
  1. Renal Perfusion [ Time Frame: 10 min ]
    Measured by Arterial Spin Labeling (ASL) MRI

  2. Renal Oxygenation [ Time Frame: 60 min ]
    Measured by Blood Oxygen Level Dependent (BOLD) MRI



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Ages Eligible for Study:   12 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03618420


Contacts
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Contact: Carissa Vinovskis, MS 720-777-2660 carissa.vinovskis@childrenscolorado.org
Contact: Petter Bjornstad, MD 720-777-4659 petter.bjornstad@childrenscolorado.org

Locations
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United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Petter Bjornstad, MD    720-777-4659    petter.bjornstad@childrenscolorado.org   
Principal Investigator: Petter Bjornstad, M.D.         
Sub-Investigator: Kristin Nadeau, M.D.         
Sponsors and Collaborators
University of Colorado Denver School of Medicine Barbara Davis Center
Investigators
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Principal Investigator: Petter Bjornstad, MD University of Colorado School of Medicine

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Responsible Party: Petter Bjornstad, Assistant Professor, University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03618420     History of Changes
Other Study ID Numbers: 17-0820
First Posted: August 7, 2018    Key Record Dates
Last Update Posted: October 19, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Complications
Kidney Diseases
Diabetic Nephropathies
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Urologic Diseases