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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2021-08-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 1 Nephropathy Diabetic Nephropathies Juvenile Diabetes Diabetes Mellitus Complication Autoimmune Diabetes Type 1 Diabetes Mellitus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All study participants will receive the same intervention.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Aminohippurate Sodium Inj 20%

Intervention Type DRUG

Diagnostic aid/agent used to measure effective renal plasma flow (ERPF)

Iohexol Inj 300 mg/mL

Intervention Type DRUG

Diagnostic aid/agent used to measure glomerular filtration rate (GFR)

Interventions

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Aminohippurate Sodium Inj 20%

Diagnostic aid/agent used to measure effective renal plasma flow (ERPF)

Intervention Type DRUG

Iohexol Inj 300 mg/mL

Diagnostic aid/agent used to measure glomerular filtration rate (GFR)

Intervention Type DRUG

Other Intervention Names

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Aminohippuric acid Para-aminohippurate (PAH) Sodium 4-amino hippurate (PAH) inj 20% 2g/10 mL omnipaque 300

Eligibility Criteria

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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

Minimum Eligible Age

12 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No