Trial Outcomes & Findings for Stress and CKD Among African Americans (NCT NCT03387319)
NCT ID: NCT03387319
Last Updated: 2020-05-12
Results Overview
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.
COMPLETED
NA
50 participants
Baseline (Minute 0), Minute 5
2020-05-12
Participant Flow
Participant milestones
| Measure |
Racialized Stressful Event Recall
Participants in this study arm recalled a stressful event related to race.
|
Non-racialized Stressful Event Recall
Participants in this study arm recalled a stressful event unrelated to race.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
25
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Stress and CKD Among African Americans
Baseline characteristics by cohort
| Measure |
Racialized Stressful Event Recall
n=25 Participants
Participants in this study arm recalled a stressful event related to race.
|
Non-racialized Stressful Event Recall
n=25 Participants
Participants in this study arm recalled a stressful event unrelated to race.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.92 years
STANDARD_DEVIATION 8.66 • n=5 Participants
|
50.12 years
STANDARD_DEVIATION 9.57 • n=7 Participants
|
52.52 years
STANDARD_DEVIATION 9.35 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Minute 0), Minute 5Level 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.
Outcome measures
| Measure |
Racialized Stressful Event Recall
n=25 Participants
Participants in this study arm recalled a stressful event related to race.
|
Non-racialized Stressful Event Recall
n=25 Participants
Participants in this study arm recalled a stressful event unrelated to race.
|
|---|---|---|
|
Change in Subjective Units of Distress Scale (SUDS) Score
|
2.92 score on a scale
Standard Deviation 2.74
|
3.12 score on a scale
Standard Deviation 3.07
|
PRIMARY outcome
Timeframe: Baseline (Minute 0), Minute 5Participants 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.
Outcome measures
| Measure |
Racialized Stressful Event Recall
n=25 Participants
Participants in this study arm recalled a stressful event related to race.
|
Non-racialized Stressful Event Recall
n=25 Participants
Participants in this study arm recalled a stressful event unrelated to race.
|
|---|---|---|
|
Change in Cooper's Racism Recall Scale Score
|
6.24 score on a scale
Standard Deviation 2.57
|
5.48 score on a scale
Standard Deviation 3.57
|
PRIMARY outcome
Timeframe: Baseline (Minute 0), Minute 90 (after both stress tests and rest periods)Population: Lab values are missing for 15 participants due to lab error.
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 protocols supplied by the manufacturer, which uses electrochemiluminescence for high sensitivity with a dynamic range of 0.09-375 pg/mL. Values presented here are the difference between the baseline and post-intervention blood draws and values greater than 0 indicate that there is an increase in inflammatory response post-intervention.
Outcome measures
| Measure |
Racialized Stressful Event Recall
n=18 Participants
Participants in this study arm recalled a stressful event related to race.
|
Non-racialized Stressful Event Recall
n=17 Participants
Participants in this study arm recalled a stressful event unrelated to race.
|
|---|---|---|
|
Change in Monocyte Chemoattractant Protein-1 (MCP-1) Level
|
193.12 pg/mL
Standard Deviation 92.80
|
217.31 pg/mL
Standard Deviation 110.47
|
PRIMARY outcome
Timeframe: Baseline (Minute 0), Minute 90 (after both stress tests and rest periods)Population: Lab values are missing for 15 participants due to lab error.
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 by the manufacturer, which uses electrochemiluminescence for high sensitivity with a dynamic range of 0.06-488 pg/mL. Values presented here are the difference between the baseline and post-intervention blood draws and values greater than 0 indicate that there is an increase in inflammatory response post-intervention.
Outcome measures
| Measure |
Racialized Stressful Event Recall
n=18 Participants
Participants in this study arm recalled a stressful event related to race.
|
Non-racialized Stressful Event Recall
n=17 Participants
Participants in this study arm recalled a stressful event unrelated to race.
|
|---|---|---|
|
Change in Interleukin-6 (IL-6) Level
|
2.23 pg/mL
Standard Deviation 1.02
|
2.11 pg/mL
Standard Deviation 1.29
|
PRIMARY outcome
Timeframe: Baseline (Minute 0), Minute 90 (after both stress tests and rest periods)Population: Lab values are missing for 15 participants due to lab error.
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 protocols supplied by the manufacturer. This assay has a high sensitivity (0.1 ng/mL) giving consistently quantitative results in plasma samples. Values presented here are the difference between the baseline and post-intervention blood draws and values greater than 0 indicate that there is an increase in inflammatory response post-intervention.
Outcome measures
| Measure |
Racialized Stressful Event Recall
n=18 Participants
Participants in this study arm recalled a stressful event related to race.
|
Non-racialized Stressful Event Recall
n=17 Participants
Participants in this study arm recalled a stressful event unrelated to race.
|
|---|---|---|
|
Change in Soluble Urokinase-type Plasminogen Activator Receptor (suPAR) Level
|
4.18 ng/mL
Standard Deviation 1.66
|
4.50 ng/mL
Standard Deviation 1.50
|
PRIMARY outcome
Timeframe: Prior to IV insertion at Minute -30 through Minute 130Blood 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 the mean increase in systolic blood pressure following the intervention, compared to the baseline time period.
Outcome measures
| Measure |
Racialized Stressful Event Recall
n=25 Participants
Participants in this study arm recalled a stressful event related to race.
|
Non-racialized Stressful Event Recall
n=25 Participants
Participants in this study arm recalled a stressful event unrelated to race.
|
|---|---|---|
|
Change in Systolic Blood Pressure
|
11.79 millimeters of mercury (mmHg)
Standard Deviation 12.76
|
15.72 millimeters of mercury (mmHg)
Standard Deviation 19.20
|
PRIMARY outcome
Timeframe: Prior to IV insertion at Minute -30 through Minute 130Blood 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 are the mean increase in diastolic blood pressure following the intervention, compared to the baseline time period.
Outcome measures
| Measure |
Racialized Stressful Event Recall
n=25 Participants
Participants in this study arm recalled a stressful event related to race.
|
Non-racialized Stressful Event Recall
n=25 Participants
Participants in this study arm recalled a stressful event unrelated to race.
|
|---|---|---|
|
Change in Diastolic Blood Pressure
|
5.52 millimeters of mercury (mmHg)
Standard Deviation 6.15
|
7.59 millimeters of mercury (mmHg)
Standard Deviation 8.37
|
Adverse Events
Racialized Stressful Event Recall
Non-racialized Stressful Event Recall
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place