Stress and CKD Among African Americans

NCT03387319 | Completed Results

• 2 other identifiers: IRB000998921R21DK112108
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease

Keywords

Social stress; Inflammation

Outcome Measures

Primary Outcomes (7)

• Change in Subjective Units of Distress Scale (SUDS) Score

  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.

  Baseline (Minute 0), Minute 5

• Change in Cooper's Racism Recall Scale Score

  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.

  Baseline (Minute 0), Minute 5

• Change in Monocyte Chemoattractant Protein-1 (MCP-1) Level

  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.

  Baseline (Minute 0), Minute 90 (after both stress tests and rest periods)

• Change in Interleukin-6 (IL-6) Level

  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.

  Baseline (Minute 0), Minute 90 (after both stress tests and rest periods)

• Change in Soluble Urokinase-type Plasminogen Activator Receptor (suPAR) Level

  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.

  Baseline (Minute 0), Minute 90 (after both stress tests and rest periods)

• Change in Systolic Blood Pressure

  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 the mean increase in systolic blood pressure following the intervention, compared to the baseline time period.

  Prior to IV insertion at Minute -30 through Minute 130

• Change in Diastolic Blood Pressure

  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 are the mean increase in diastolic blood pressure following the intervention, compared to the baseline time period.

  Prior to IV insertion at Minute -30 through Minute 130

Study Arms (2)

Racialized Stressful Event Recall

EXPERIMENTAL

Participants in this study are recall a stressful event related to race.

Behavioral: Racialized Stressful Event Recall

Non-racialized Stressful Event Recall

EXPERIMENTAL

Participants in this study arm recall a stressful event unrelated to race.

Behavioral: Non-Racialized Stressful Event Recall

Interventions

Racialized Stressful Event Recall BEHAVIORAL

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.

Racialized Stressful Event Recall

Non-Racialized Stressful Event Recall BEHAVIORAL

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.

Non-racialized Stressful Event Recall

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

Related Publications (1)

• Arriola KJ, Lewis TT, Pearce B, Cobb J, Weldon B, Valentin MIZ, Lea J, Vaccarino V. A randomized trial of race-related stress among African Americans with chronic kidney disease. Psychoneuroendocrinology. 2021 Sep;131:105339. doi: 10.1016/j.psyneuen.2021.105339. Epub 2021 Jun 18.

  PMID: 34175554 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Inflammation

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Kimberly R Jacob Arriola, PhD, MPH
• Organization: Emory University

kjacoba@emory.edu

404-727-2600

Study Officials

• Kimberly Arriola, PhD, MPH

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Of the 100 participants recruited, 80 will have a diagnosis of chronic kidney disease (CKD) and 20 will not. Participants will be randomized such that half will recall the racial experience and half will recall the non-racialized stressful event. Each participant will have an equal chance of being placed in the racialized or non-racialized experience group.

Study Record Dates

• First Submitted: December 20, 2017
• First Posted: January 2, 2018
• Study Start: April 27, 2018
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2019
• Last Updated: May 12, 2020
• Results First Posted: May 12, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)