NCT03387319

Stress and CKD Among African Americans

Completed NA Results posted Last updated 12 May 2020

What this trial tests

NA trial testing Racialized Stressful Event Recall in Chronic Kidney Disease in 50 participants. Completed in 30 April 2019.

Timeline

27 April 2018

Primary endpoint
30 April 2019

30 April 2019

Quick facts

Lead sponsor	Emory University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	50
Start date	27 April 2018
Primary completion	30 April 2019
Estimated completion	30 April 2019
Sites	1 location across United States

Drugs / interventions tested

• Racialized Stressful Event Recall
• Non-Racialized Stressful Event Recall

Conditions studied

• Chronic Kidney Disease — all drugs for Chronic Kidney Disease →

Sponsor

Emory University

Who can join

Adults 25 to 65, any sex, with Chronic Kidney Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Subjective Units of Distress Scale (SUDS) Score Primary · Baseline (Minute 0), Minute 5

Level of distress will be measured with the Subjective Units of Distress Scale (SUDS). Participants rate their distress on a linear scale from 0 to 100, where 0 = No distress; totally relaxed, 50 = Moderate anxiety/distress; uncomfortable, but can continue to function, 100 = Highest anxiety/distress ever felt. The SUDS will be administered at baseline and after the first stress task. The change in SUDS scores is presented here. Scores above zero mean that the participants experienced an increase in distress following the stress task.

Group	Value	95% CI
Racialized Stressful Event Recall	2.92	± 2.74
Non-racialized Stressful Event Recall	3.12	± 3.07

Change in Cooper's Racism Recall Scale Score Primary · Baseline (Minute 0), Minute 5

Participants will report their level of stress directly related to reliving the stressful experience using an adapted version of Cooper's Racism Recall Scale. Participants reported their level of distress at the time of the event and currently while thinking about the event, on a linear scale from 0 to 10 where higher values indicate higher distress. Values presented here are the change from baseline and values greater than 0 mean that stress increased from before (baseline) and after the stressful event recall.

Group	Value	95% CI
Racialized Stressful Event Recall	6.24	± 2.57
Non-racialized Stressful Event Recall	5.48	± 3.57

Change in Monocyte Chemoattractant Protein-1 (MCP-1) Level Primary · Baseline (Minute 0), Minute 90 (after both stress tests and rest periods)

Monocyte Chemoattractant Protein-1 (MCP-1) is an inflammatory marker that is sensitive to acute stress induction and is associated with chronic kidney disease (CKD). Blood will be drawn three times, at 30 minutes after the IV catheter is inserted (prior to the stressful event recall) and after each 45 minute recovery period following the stress tests, in order to compare MCP-1 levels at before and after the study intervention. Increased MCP-1 indicates an increased inflammatory response. MCP-1 levels will be quantitated by the MesoScale system (MSD Rockville, Maryland) according to the protoco

Group	Value	95% CI
Racialized Stressful Event Recall	193.12	± 92.80
Non-racialized Stressful Event Recall	217.31	± 110.47

Change in Interleukin-6 (IL-6) Level Primary · Baseline (Minute 0), Minute 90 (after both stress tests and rest periods)

Interleukin-6 (IL-6) is an inflammatory marker that is sensitive to acute stress induction and is associated with CKD. Blood will be drawn three times, at 30 minutes after the IV catheter is inserted (prior to the intervention) and after each 45 minute recovery period following the stress tests, in order to compare IL-6 levels at before and after the study intervention. IL-6 is influenced by a variety of factors and increases in IL-6 indicate an increased inflammatory response. IL-6 levels will be quantitated by the MesoScale system (MSD Rockville, Maryland) according to the protocols supplied

Group	Value	95% CI
Racialized Stressful Event Recall	2.23	± 1.02
Non-racialized Stressful Event Recall	2.11	± 1.29

Change in Soluble Urokinase-type Plasminogen Activator Receptor (suPAR) Level Primary · Baseline (Minute 0), Minute 90 (after both stress tests and rest periods)

Soluble urokinase-type plasminogen activator receptor (suPAR) is an inflammatory marker that is sensitive to acute stress induction and is associated with CKD. Blood will be drawn three times at 30 minutes after the IV catheter is inserted (prior to the intervention) and after each 45 minute recovery period following the stress tests, in order to compare suPAR levels at before and after the study intervention. Increases in suPAR indicate an increased inflammatory response. suPAR will be measured with the Virogates (CEDARLANE Laboratories, Burlington, NC) suPARnostic® ELISA, according to the pr

Group	Value	95% CI
Racialized Stressful Event Recall	4.18	± 1.66
Non-racialized Stressful Event Recall	4.50	± 1.50

Change in Systolic Blood Pressure Primary · Prior to IV insertion at Minute -30 through Minute 130

Blood pressure readings will be taken at baseline and every 5 minutes during the experimental manipulation, except during the recall task when blood pressure will be measured every 1 minute. Mean systolic blood pressure scores for rest, recall task, and recovery will be calculated by averaging the readings taken during each period. Blood pressure reactivity will be a change score, calculated as the mean of the scores during the recall task minus the mean of the scores during rest, designed to represent the change in systolic blood pressure induced by the recall task. Values greater than 0 are

Group	Value	95% CI
Racialized Stressful Event Recall	11.79	± 12.76
Non-racialized Stressful Event Recall	15.72	± 19.20

Change in Diastolic Blood Pressure Primary · Prior to IV insertion at Minute -30 through Minute 130

Blood pressure readings will be taken at baseline and every 5 minutes during the experimental manipulation, except during the recall task when blood pressure will be measured every 1 minute. Mean diastolic blood pressure scores for rest, recall task, and recovery will be calculated by averaging the readings taken during each period. Blood pressure reactivity will be a change score, calculated as the mean of the scores during the recall task minus the mean of the scores during rest, designed to represent the change in diastolic blood pressure induced by the recall task. Values greater than 0 ar

Group	Value	95% CI
Racialized Stressful Event Recall	5.52	± 6.15
Non-racialized Stressful Event Recall	7.59	± 8.37

Sponsor's own description

The goal of this study is to determine whether experiencing stress from discrimination may increase chronic kidney disease (CKD) progression in African Americans. Study participation occurs over the course of 2 days, and participant time burden is expected to be about 4.5 hours, plus a 24-hour period of wearing a blood pressure monitor.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A randomized trial of race-related stress among African Americans with chronic kidney disease.
   Arriola KJ, Lewis TT, Pearce B, Cobb J, et al · · 2021 · cited 7× · PMID 34175554 · DOI 10.1016/j.psyneuen.2021.105339