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NCT03878277 · ClinicalTrials.gov registry record · Phase 2
Evaluation of Coffee Therapy for Improvement of Renal Oxygenation
A Phase 2 study of Diabetic Kidney Disease and Type1diabetes, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT03878277 is a Phase 2 study of Diabetic Kidney Disease and Type1diabetes that has completed, run by University of Colorado, Denver. The registered enrollment target is 10 participants, below the 5,189-participant average among 23 other Diabetic Kidney Disease trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03878277, a Phase 2 study of Diabetic Kidney Disease and Type1diabetes, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
Over 1.25 million Americans have Type 1 Diabetes (T1D), increasing risk for early death from cardiovascular disease (CVD). Despite advances in glycemic and blood pressure control, a child diagnosed with T1D is expected to live up to 17 years less than non-diabetic peers. The strongest risk factor for 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. This limited progress may relate to a narrow focus on clinical manifestations of disease, rather than on the initial metabolic derangements underlying the initiation of DKD. Renal hypoxia, stemming from a potential metabolic mismatch between increased renal energy expenditure and impaired substrate utilization, is increasingly proposed as a unifying early pathway in the development of DKD. T1D is impacted by several mechanisms which increase renal adenosine triphosphate (ATP) consumption and decrease ATP generation. Caffeine, a methylxanthine, is known to alter kidney function by several mechanisms including natriuresis, hemodynamics and renin-angiotensin-aldosterone system. In contrast, to other natriuretic agents, caffeine is thought to fully inhibit the local tubuloglomerular feedback (TGF) response to increased distal sodium delivery. This observation has broad-ranging implications as caffeine can reduce renal oxygen (O2) consumption without impairing effective renal plasma flow (ERPF) and glomerular filtration rate (GFR). There are also data suggesting that chemicals in coffee besides caffeine may provide important cardio-renal protection. Yet, there are no data examining the impact of coffee-induced natriuresis on intrarenal hemodynamic function and renal energetics in youth-onset T1D. Our overarching hypothesis in the proposed pilot and feasibility trial is that coffee drinking improves renal oxygenation by reducing renal O2 consumption without impairing GFR and ERPF. To address
Conditions Studied
Interventions
- DRUG Starbucks® Cold brew - 325ml bottle
Study Locations (1)
Colorado
- Children's Hospital Colorado - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2019-07-01 |
| Est. Completion | 2021-09-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03878277
The ClinicalTrials.gov registry entry for NCT03878277 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 5,189-participant average among 23 other Diabetic Kidney Disease trials with a reported enrollment target (100% 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 Diabetic Kidney Disease appearing as the primary indexed condition, and to 1 intervention - of which Starbucks® Cold brew - 325ml bottle is the first listed.
NCT03878277 reports 1 study location spanning 1 distinct geographic area - top geographies include Colorado.
Frequently Asked Questions
What is clinical trial NCT03878277 about?
NCT03878277 is a clinical study titled "Evaluation of Coffee Therapy for Improvement of Renal Oxygenation". Over 1.25 million Americans have Type 1 Diabetes (T1D), increasing risk for early death from cardiovascular disease (CVD). Despite advances in glycemic and blood pressure control, a child diagnosed with T1D is expected to live up to 17 years less than non-diabetic peers. The strongest risk factor fo...
What is the current status of trial NCT03878277?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2019-07-01. Estimated completion is 2021-09-30.
What conditions does trial NCT03878277 study?
This clinical trial studies the following conditions: Diabetic Kidney Disease, Type1diabetes, Diabetic Nephropathies, Diabetes Complications, Type1 Diabetes Mellitus.
What interventions are being tested in trial NCT03878277?
The interventions under investigation include: Starbucks® Cold brew - 325ml bottle (DRUG).
Who is sponsoring clinical trial NCT03878277?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03878277 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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