search
Back to results

Stress, Inflammation and Immune Response Pilot Study- Aim 3

Primary Purpose

Systemic Lupus Erythematosus, Inflammation

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
App based mindfulness program (ABMP)
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Systemic Lupus Erythematosus focused on measuring Neutrophil, Meditation

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Lupus diagnosis according to >4 ACR 1987 criteria or >4 SLICC 2012 criteria or a diagnosis confirmed by a board-certified rheumatologist
  • Capacity to provide informed consent and ability to speak and read English
  • BMI under 35
  • Must have access to an iOS or android smartphone to allow daily use of an app

Exclusion Criteria:

  • Currently participating in another clinical trial with intervention. Participation in observational clinical trials is not grounds for exclusion.
  • History of significant systemic disease (eg. cancer, infection, hematological, renal, hepatic, coronary artery disease or other cardiovascular disease, endocrinological (diabetes), neurologic, rheumatologic, or gastrointestinal disease)
  • Acute illness or evidence of clinically significant active infection
  • Pregnant, breast feeding or less than 6 months post-partum
  • Taking prescribed psychotropic or central nervous system altering medications
  • History of a diagnosed Bipolar Disorder, Schizophrenia, or Schizoaffective Disorder, epilepsy or seizures
  • Individuals who are currently undergoing a depressive episode. Can include those who are under treatment and not depressed currently.
  • Excluded based upon the screening visit
  • Use of nicotine
  • Significant previous training or significant current practice in meditation
  • Completed Mindfulness Based Stress Reduction (MBSR) in the past
  • Current meditation practice. Judgment: Participants will be included or excluded at the PIs discretion due to wide variation in responses (e.g. 2 people answer yes, one practices mindfulness 2x/week for 2 years (exclude), the other attends regular religious services (include))
  • Significant daily practice with other mind-body techniques
  • Daily Yoga or Tai Chi Practice - exclude
  • Other daily practice - judgment

Sites / Locations

  • University of WisconsinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

control

App based mindfulness program (ABMP)

Arm Description

Control

Participants in this group will participate in App based mindfulness program (ABMP)

Outcomes

Primary Outcome Measures

Change in neutrophil function as assessed by Neutrophil extracellular trap(NET) formation
Change in phagocytic index of neutrophils
Neutrophil phagocytosis is measured by quantifying the ingestion of fluorescent zymosan or E.coli bioparticles using fluorescence microscopy. A phagocytic index is calculated to report the number of particles phagocytosed per cell.
Change in neutrophil function as assessed by reactive oxygen species (ROS) production
Change in neutrophils' migratory ability as assessed by change in neutrophils' velocity
Neutrophil migration is assessed using time lapse microscopy. The migration patterns of individual neutrophils are measured using NIH Image J FIJI and velocity (μm/min) is measured.
Change in neutrophils' migratory ability as assessed by change in "distance travelled" by neutrophils
Neutrophil migration is assessed using time lapse microscopy. The migration patterns of individual neutrophils are measured using NIH Image J FIJI and distance (μm) is quantified.
Change in the expression of stress-induced genes

Secondary Outcome Measures

Change in inflammatory cytokines level
Peripheral blood mononuclear cells (PBMC) and sub-populations including CD8 T cells and NK cells will be isolated from blood to study inflammatory cytokines level.
Change in expression of 'immune cells activation markers'
Change in the monocyte activation level
Monocytes will be analyzed by flow cytometry for activation markers and other markers of cell function.
Change in the methylation pattern of stress-induced genes
Change in the gene expression pattern of stress induced genes
Change in the cytokine secretion level from immune cells

Full Information

First Posted
April 8, 2021
Last Updated
March 27, 2023
Sponsor
University of Wisconsin, Madison
search

1. Study Identification

Unique Protocol Identification Number
NCT04857151
Brief Title
Stress, Inflammation and Immune Response Pilot Study- Aim 3
Official Title
Stress, Inflammation and Immune Response Pilot Study- Aim 3
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 2, 2022 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The overall goal of this study is to investigate the effects of stress and glucose intake at the molecular level including gene expression, protein and functional analysis of immune cells in real time. Aim 1- Characterizing the immune response after acute stress and glucose consumption Aim 2- Temporal mapping of the modulation of immune cell function via meditation Aim 3-Influence of meditative practice on lupus patients Aim 4-Influence of meditative practice on healthy subjects Current Clinicaltrials.gov record, will be focused on Aim-3 only. Aim-3 will test whether meditation alters neutrophil function and inflammation in patients with lupus. Study team will investigate whether patient neutrophils have altered NET formation, phagocytosis, ROS signaling and migration after ABMP. Innate immune function via analysis of monocytes by flow cytometry will also be analyzed. Other immune cell responses including CD8 T cells will also be investigated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus, Inflammation
Keywords
Neutrophil, Meditation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control
Arm Type
No Intervention
Arm Description
Control
Arm Title
App based mindfulness program (ABMP)
Arm Type
Experimental
Arm Description
Participants in this group will participate in App based mindfulness program (ABMP)
Intervention Type
Behavioral
Intervention Name(s)
App based mindfulness program (ABMP)
Intervention Description
App based mindfulness program (ABMP)
Primary Outcome Measure Information:
Title
Change in neutrophil function as assessed by Neutrophil extracellular trap(NET) formation
Time Frame
Baseline and 8 weeks
Title
Change in phagocytic index of neutrophils
Description
Neutrophil phagocytosis is measured by quantifying the ingestion of fluorescent zymosan or E.coli bioparticles using fluorescence microscopy. A phagocytic index is calculated to report the number of particles phagocytosed per cell.
Time Frame
Baseline and 8 weeks
Title
Change in neutrophil function as assessed by reactive oxygen species (ROS) production
Time Frame
Baseline and 8 weeks
Title
Change in neutrophils' migratory ability as assessed by change in neutrophils' velocity
Description
Neutrophil migration is assessed using time lapse microscopy. The migration patterns of individual neutrophils are measured using NIH Image J FIJI and velocity (μm/min) is measured.
Time Frame
Baseline and 8 weeks
Title
Change in neutrophils' migratory ability as assessed by change in "distance travelled" by neutrophils
Description
Neutrophil migration is assessed using time lapse microscopy. The migration patterns of individual neutrophils are measured using NIH Image J FIJI and distance (μm) is quantified.
Time Frame
Baseline and 8 weeks
Title
Change in the expression of stress-induced genes
Time Frame
Baseline and 8 weeks
Secondary Outcome Measure Information:
Title
Change in inflammatory cytokines level
Description
Peripheral blood mononuclear cells (PBMC) and sub-populations including CD8 T cells and NK cells will be isolated from blood to study inflammatory cytokines level.
Time Frame
Baseline and 8 weeks
Title
Change in expression of 'immune cells activation markers'
Time Frame
Baseline and 8 weeks
Title
Change in the monocyte activation level
Description
Monocytes will be analyzed by flow cytometry for activation markers and other markers of cell function.
Time Frame
Baseline and 8 weeks
Title
Change in the methylation pattern of stress-induced genes
Time Frame
Baseline and 8 weeks
Title
Change in the gene expression pattern of stress induced genes
Time Frame
Baseline and 8 weeks
Title
Change in the cytokine secretion level from immune cells
Time Frame
Baseline and 8 weeks
Other Pre-specified Outcome Measures:
Title
Change in PROMIS-GH (Patient-Reported Outcomes Measurement Information System Global Health) score
Description
PROMIS self-report measures are intended to be completed by the respondent without help from anyone else. The PROMIS GH is comprised of 10 global items. Each item represents a different domain of health. Mental health and physical health summary scores are computed and standardized to the general population. Both these component scores and individual global items can be used to assess patients' perceptions of their health. PROMIS global health can be converted to raw scores between 4-20 that can be converted to a t-score of 16.2-67.7. A higher score reflects better functioning.
Time Frame
Baseline and 8 weeks
Title
Change in State Trait Anxiety Inventory (STAI) Score
Description
The State Trail Anxiety Inventory is a 20 item questionnaire about how the participant is feeling. The total possible range of scores is 20-80 lower scores indicate less anxiety.
Time Frame
Baseline and 8 weeks
Title
Change in Five Facet Mindfulness Questionnaire (FFMQ)
Description
FFMQ is a 39-item questionnaire scored on a 5 pt likert scale for a total possible range of scores 39-195 where higher scores indicate increased mindfulness.
Time Frame
Baseline and 8 weeks
Title
Change in the Perceived Stress Scale
Description
The Perceived Stress Scale is a 10-item survey scored on a 5-pt likert scale for a total possible range of scores 0-40 where higher scores indicate increased perceived stress.
Time Frame
Baseline and 8 weeks
Title
Change in PROMIS-Positive Affect Score
Description
The PROMIS-Positive Affect Score is based on a 15-item survey, each item scored on a 5-pt likert scale for a total possible range of scores 15-75 where higher score indicated higher positivity.
Time Frame
Baseline and 8 weeks
Title
Change in PROMIS-Depression Score
Description
The PROMIS-Depression Score is based on a 6-item survey, each item scored on a 5-pt likert scale for a total possible range of scores 6-30 where higher score indicate increased depression.
Time Frame
Baseline and 8 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Lupus is about nine times more common in females than in males.
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Lupus diagnosis according to >4 ACR 1987 criteria or >4 SLICC 2012 criteria or a diagnosis confirmed by a board-certified rheumatologist Capacity to provide informed consent and ability to speak and read English BMI under 35 Must have access to an iOS or android smartphone to allow daily use of an app Exclusion Criteria: Currently participating in another clinical trial with intervention. Participation in observational clinical trials is not grounds for exclusion. History of significant systemic disease (eg. cancer, infection, hematological, renal, hepatic, coronary artery disease or other cardiovascular disease, endocrinological (diabetes), neurologic, rheumatologic, or gastrointestinal disease) Acute illness or evidence of clinically significant active infection Pregnant, breast feeding or less than 6 months post-partum Taking prescribed psychotropic or central nervous system altering medications History of a diagnosed Bipolar Disorder, Schizophrenia, or Schizoaffective Disorder, epilepsy or seizures Individuals who are currently undergoing a depressive episode. Can include those who are under treatment and not depressed currently. Excluded based upon the screening visit Use of nicotine Significant previous training or significant current practice in meditation Completed Mindfulness Based Stress Reduction (MBSR) in the past Current meditation practice. Judgment: Participants will be included or excluded at the PIs discretion due to wide variation in responses (e.g. 2 people answer yes, one practices mindfulness 2x/week for 2 years (exclude), the other attends regular religious services (include)) Significant daily practice with other mind-body techniques Daily Yoga or Tai Chi Practice - exclude Other daily practice - judgment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alice Golubiewski
Phone
608-263-7272
Email
agolubiewski@wisc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Beebe, PhD
Organizational Affiliation
UW Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alice Golubiewski,
Phone
608-263-7272
Email
agolubiewski@wisc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Stress, Inflammation and Immune Response Pilot Study- Aim 3

We'll reach out to this number within 24 hrs