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Stress and CKD Among African Americans

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ClinicalTrials.gov Identifier: NCT03387319
Recruitment Status : Not yet recruiting
First Posted : January 1, 2018
Last Update Posted : January 17, 2018
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Chronic Kidney Disease Behavioral: Racialized Stressful Event Recall Behavioral: Non-Racialized Stressful Event Recall

Detailed Description:

On Day 1, the project coordinator will explain the study to participants and answer any questions he/she may have. Those who agree to participate in the study will provide consent at the clinic and will also be asked to complete a questionnaire on an iPad in a small, private room at the clinic. The participant will complete the questionnaire alone, however, the project coordinator will read questions aloud if the participant chooses. Before leaving on Day 1, participants will fitted with a blood pressure monitor to be worn for the next 24 hours.

The clinical intervention portion of the study occurs during the morning of Day 2 (between 9:00 AM and 11:00 AM). Participants will be instructed to bring the blood pressure monitor and a list of current medications (or the actual medications) with them. First, participants will provide a urine sample and undergo blood pressure testing. A research nurse will insert a catheter (a small thin tube) into the participant's vein, and allow a 30-minute resting period so that the participant gets used to the catheter, and then take a baseline blood draw. Participants will judge how distressed they feel in that moment using a standard scale and tell the project coordinator his/her rating. Next, participants will be asked to recall two stressful experiences - one related to race and the other not related to race. Participants will be randomized to the order that they tell these stories. An audience of two observers of same race will wear white coats and watch as the participants recall the stressful events. The research nurse will draw blood and take blood pressure measurements at multiple time points during both recall experiences. Immediately before and after each recall task, the participant will again judge how distressed he/she is feeling in that moment using the same scale as before. The project coordinator will explain the purpose of the story recall and common ways that individuals may respond to the task (such as feeling anxious after the task). A total of 100 people will take part in this study.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Participants will receive both interventions and will be randomized to which order the interventions are received. Of the 100 participants recruited, 80 will have a diagnosis of chronic kidney disease (CKD) and 20 will not.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Social Stress, Inflammation, and Chronic Kidney Disease Among African Americans
Anticipated Study Start Date : February 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Racialized Stressful Event Recall
Participant presents stressful event (1) related to race then (2) unrelated to race.
Behavioral: Racialized Stressful Event Recall

Participants will undergo a moderate psychological stress adapted from the Trier Social Stress Test (TSST) where they will be asked to recall a stressful, real-life, race-related event.

After instructions are provided, participants will be given two minutes to prepare their statement, and three minutes to deliver their statement. There will be an 'audience' present at each participant's speaking task which will include two observers who are of same race as the participant (African American), to heighten stress responses.

Participants will undergo a 45-minute recovery period after the recall task.

Behavioral: Non-Racialized Stressful Event Recall

Participants will undergo a moderate psychological stress adapted from the Trier Social Stress Test (TSST) where they will be asked to recall a stressful, real-life, event unrelated to race.

After instructions are provided, participants will be given two minutes to prepare their statement, and three minutes to deliver their statement. There will be an 'audience' present at each participant's speaking task which will include two observers who are of same race as the participant (African American), to heighten stress responses.

Participants will undergo a 45-minute recovery period after the recall task.

Experimental: Non-racialized Stressful Event Recall
Participant presents stressful event (1) unrelated to race then (2) related to race then
Behavioral: Racialized Stressful Event Recall

Participants will undergo a moderate psychological stress adapted from the Trier Social Stress Test (TSST) where they will be asked to recall a stressful, real-life, race-related event.

After instructions are provided, participants will be given two minutes to prepare their statement, and three minutes to deliver their statement. There will be an 'audience' present at each participant's speaking task which will include two observers who are of same race as the participant (African American), to heighten stress responses.

Participants will undergo a 45-minute recovery period after the recall task.

Behavioral: Non-Racialized Stressful Event Recall

Participants will undergo a moderate psychological stress adapted from the Trier Social Stress Test (TSST) where they will be asked to recall a stressful, real-life, event unrelated to race.

After instructions are provided, participants will be given two minutes to prepare their statement, and three minutes to deliver their statement. There will be an 'audience' present at each participant's speaking task which will include two observers who are of same race as the participant (African American), to heighten stress responses.

Participants will undergo a 45-minute recovery period after the recall task.



Outcome Measures

Primary Outcome Measures :
  1. Subjective Units of Distress Scale (SUDS) Score [ Time Frame: Minute 30 through Minute 130 ]
    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 5 times in a single day: 30 minutes after the intravenous (IV) catheter is inserted, after the first stress task (35 minutes after the IV catheter is inserted), after a 45 minute recovery period (80 minutes after the IV catheter is inserted), after the second stress test (85 minutes after the IV catheter is inserted), and after another 45 minute recovery period (130 minutes after the IV catheter is inserted).

  2. Change in Monocyte Chemoattractant Protein-1 (MCP-1) [ Time Frame: Minute 30 through Minute 130 ]

    Monocyte Chemoattractant Protein-1 (MCP-1) 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 and after each 45 recovery period following the stress tests, in order to compare MCP-1 levels at each of these time points.

    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.


  3. Change in Interleukin-6 (IL-6) [ Time Frame: Minute 30 through Minute 130 ]

    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 and after each 45 recovery period following the stress tests, in order to compare IL-6 levels at each of these time points.

    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.


  4. Change in soluble urokinase-type plasminogen activator receptor (suPAR) [ Time Frame: Minute 30 through Minute 130 ]

    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 and after each 45 recovery period following the stress tests, in order to compare suPAR levels at each of these time points.

    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.


  5. Change in systolic blood pressure [ Time Frame: Baseline 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.

  6. Change in diastolic blood pressure [ Time Frame: Baseline 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.


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   25 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient at Emory University Hospital Midtown
  • Self-identify as African American or Black
  • Estimated glomerular filtration rate (eGFR) ≥ 15, or <90

Exclusion Criteria:

  • Mental disorder that prevents the completion of the Computer Assisted Personal Interview (CAPI) and the stressful recall manipulation
  • Currently on maintenance dialysis
  • Unable or unwilling to undergo intravenous catheterization
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03387319


Contacts
Contact: Kimberly Arriola, PhD, MPH 404-727-2600 kjacoba@emory.edu
Contact: Nakeva Redmond, MPH 404-727-2386 nakeva.redmond@emory.edu

Locations
United States, Georgia
Emory University Hospital Midtown Not yet recruiting
Atlanta, Georgia, United States, 30308
Contact: Nakeva Redmond, MPH    404-727-2386    nakeva.redmond@emory.edu   
Contact: Kimberly Arriola, PhD, MPH    404-727-2600    kjacoba@emory.edu   
Sponsors and Collaborators
Emory University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Kimberly Arriola, PhD, MPH Emory University
More Information

Responsible Party: Kimberly R Jacob Arriola, PhD, MPH, Professor, Emory University
ClinicalTrials.gov Identifier: NCT03387319     History of Changes
Other Study ID Numbers: IRB00099892
1R21DK112108 ( U.S. NIH Grant/Contract )
First Posted: January 1, 2018    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kimberly R Jacob Arriola, PhD, MPH, Emory University:
Social stress
Inflammation

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency