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NCT03618420 · ClinicalTrials.gov registry record · Phase 1
Copeptin in Adolescent Participants With Type 1 Diabetes and Early Renal Hemodynamic Function
A Phase 1 study of Diabetes Mellitus, Type 1 and Type 1 Diabetes Mellitus, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT03618420 is a Phase 1 study of Diabetes Mellitus, Type 1 and Type 1 Diabetes Mellitus that has completed, run by University of Colorado, Denver. The registered enrollment target is 50 participants, below the 1,266-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03618420, a Phase 1 study of Diabetes Mellitus, Type 1 and Type 1 Diabetes Mellitus, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG Aminohippurate Sodium Inj 20%
- DRUG Iohexol Inj 300 mg/mL
Study Locations (1)
Colorado
- Children's Hospital Colorado - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2018-10-01 |
| Est. Completion | 2021-08-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03618420
The ClinicalTrials.gov registry entry for NCT03618420 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,266-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (96% lower). The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.
The record links to 7 conditions, with Diabetes Mellitus, Type 1 appearing as the primary indexed condition, and to 2 interventions - of which Aminohippurate Sodium Inj 20% is the first listed.
NCT03618420 reports 1 study location spanning 1 distinct geographic area - top geographies include Colorado.
Frequently Asked Questions
What is clinical trial NCT03618420 about?
NCT03618420 is a clinical study titled "Copeptin in Adolescent Participants With Type 1 Diabetes and Early Renal Hemodynamic Function". 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, a...
What is the current status of trial NCT03618420?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2018-10-01. Estimated completion is 2021-08-01.
What conditions does trial NCT03618420 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 1, Type 1 Diabetes Mellitus, Diabetic Nephropathies, Autoimmune Diabetes, Nephropathy.
What interventions are being tested in trial NCT03618420?
The interventions under investigation include: Aminohippurate Sodium Inj 20% (DRUG), Iohexol Inj 300 mg/mL (DRUG).
Who is sponsoring clinical trial NCT03618420?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03618420 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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