Trial · NCT03878277
Evaluation of Coffee Therapy for Improvement of Renal Oxygenation
NCT03878277, Phase 2, Completed, University of Colorado, Denver; results first posted 2021-08-31
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluation of Coffee Therapy for Improvement of Renal Oxygenation. Trials, record NCT03878277. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03878277
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of Coffee Therapy for Improvement of Renal Oxygenation
- NCT number
- NCT03878277
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 10 participants, actual
- Lead sponsor
- University of Colorado, Denver
- Conditions
- Type1diabetes, Type1 Diabetes Mellitus, Diabetic Kidney Disease, Juvenile Diabetes, Diabetic Nephropathies, Diabetes Complications, Diabetes, Autoimmune
- Interventions
- Starbucks® Cold brew - 325ml bottle
- First posted
- 2019-03-18
- Last updated
- 2022-02-15
- Results first posted
- 2021-08-31
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Renal Oxygenation | 1 hour | Measured by blood oxygen level dependent (BOLD MRI), before and after Lasix injection;Regions of interest (ROI) analysis for BOLD MRI will be performed on a Leonardo Workstation (Siemens Medical Systems, Germany). Typically, 1 to 3 regions in each, cortex and medulla, per kidney per slice will be defined leading to a total of about 10 ROIs per region (cortex and medulla) per subject. The mean and standard deviation of these 10 measurements will be used a R2\* measurement for the region, for the subject and for that time point. Additionally, two (delta) R2\*s will be calculated as defined below: (delta) R2\*(medulla, furosemide) = R2\* (medulla, pre-furosemide) - R2\* (medulla, post-furosemide); (delta) R2\*(cortex, medulla) = Baseline R2\* (medulla) - Baseline R2\* (cortex). |
| Primary | Renal Perfusion | 1 hour | Measured by pseudocontinuous arterial spin labeling (pCASL) MRI; ROI analysis will be used to estimate (delta) M (difference in signal intensity between non-selective and selective inversion images). Using the same ROI, M0 will be estimated from the proton density image. T1 measurements from the same ROI will be obtained by fitting the signal intensity vs. inversion time data as described previously (104) using XLFit (ID Business Solutions Ltd., UK) or T1 maps created using MRI Mapper (Beth Israel Deaconess Medical Center, Boston). Partition coefficient will be assumed to be 0.8 ml/gm (105, 106). These values will then be used to estimate regional blood flow. |
| Secondary | Glomerular Filtration Rate | 4 hours | Measured by Iohexol clearance; An intravenous (IV) line was placed, and participants were asked to empty their bladders. Spot plasma and urine samples were collected prior to iohexol infusion. Iohexol was administered through bolus IV injection (5 mL of 300 mg/mL; Omnipaque 300, GE Healthcare). An equilibration period of 120 min was used and blood collections for iohexol plasma disappearance were drawn at +120, +150, +180, +210, +240 min (11). Because the Brøchner-Mortensen equation underestimates high values of GFR, the Jødal-Brøchner-Mortensen equation was used to calculate the GFR (12). We report absolute GFR (mL/min) and RPF (mL/min) in the main analyses because the practice of indexing GFR and RPF for body surface underestimates hyperfiltration and hyperperfusion (14), and body surface area (BSA) calculations introduce noise into the clearance measurements. |
| Secondary | Effective Renal Plasma Flow | 4 hours | Measured by para-aminohippurate (PAH) clearance; An intravenous (IV) line was placed, and participants were asked to empty their bladders. Spot plasma and urine samples were collected prior PAH infusion. PAH (2 g/10 mL, prepared at the University of Minnesota, with a dose of \[weight in kg\]/75 × 4.2 mL; IND #140129) was given slowly over 5 min followed by a continuous infusion of 8 mL of PAH and 42 mL of normal saline at a rate of 24 mL/h for 2 h. After an equilibration period, blood was drawn at 90 and 120 min, and RPF was calculated as PAH clearance divided by the estimated extraction ratio of PAH, which varies by the level of GFR (13). We report absolute GFR (mL/min) and RPF (mL/min) in the main analyses because the practice of indexing GFR and RPF for body surface underestimates hyperfiltration and hyperperfusion (14), and body surface area (BSA) calculations introduce noise into the clearance measurements. |
| Secondary | Tubular Injury Markers | 4 hours | Measured by markers of kidney injury in plasma; Cystatin C (mg/L) was measured by immunoturbidimetric method (Kamiya Biomedical) by our Clinical Translational Research Center Core Laboratory. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Renal Oxygenation | 1 hour | s^-1 | MEAN | |
| PRIMARY | Renal Perfusion | 1 hour | ml/s/100g | MEAN | |
| SECONDARY | Glomerular Filtration Rate | 4 hours | ml/s | MEAN | |
| SECONDARY | Effective Renal Plasma Flow | 4 hours | ml/s | MEAN | |
| SECONDARY | Tubular Injury Markers | 4 hours | mg/L | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Renal Oxygenation | Cold Brew Coffee | Before cold brew | 22.4 | Standard Deviation 1.5 | s^-1 |
| Renal Oxygenation | Cold Brew Coffee | After cold brew | 22.5 | Standard Deviation 2.1 | s^-1 |
| Renal Perfusion | Cold Brew Coffee | Before cold brew (Right kidney ASL) | 3.02 | Standard Deviation 0.67 | ml/s/100g |
| Renal Perfusion | Cold Brew Coffee | After cold brew (Right kidney ASL) | 3.03 | Standard Deviation 0.62 | ml/s/100g |
| Renal Perfusion | Cold Brew Coffee | Before cold brew (Left kidney ASL) | 3.15 | Standard Deviation 0.50 | ml/s/100g |
| Renal Perfusion | Cold Brew Coffee | After cold brew (Left kidney ASL) | 3.03 | Standard Deviation 0.72 | ml/s/100g |
| Glomerular Filtration Rate | Cold Brew Coffee | Before cold brew | 3.25 | Standard Deviation 0.47 | ml/s |
| Glomerular Filtration Rate | Cold Brew Coffee | After cold brew | 3.27 | Standard Deviation 0.80 | ml/s |
| Effective Renal Plasma Flow | Cold Brew Coffee | Before cold brew | 13.08 | Standard Deviation 1.58 | ml/s |
| Effective Renal Plasma Flow | Cold Brew Coffee | After cold brew | 13.02 | Standard Deviation 0.67 | ml/s |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cold Brew Coffee | 10 | |
| Overall Study | COMPLETED | Cold Brew Coffee | 10 | |
| Overall Study | NOT COMPLETED | Cold Brew Coffee | 0 |
Source ClinicalTrials.gov
Adverse events1
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Vasovagal syncope | Vascular disorders | Cold Brew Coffee | 1 | 10 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cold Brew Coffee | 0 | 10 |
| Total, other adverse events | Cold Brew Coffee | 1 | 10 |
| Total, serious adverse events | Cold Brew Coffee | 0 | 10 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03878277
GET https://conductscience.org/api/trials/v1/NCT03878277/registered