Stress, Inflammation and Immune Response Pilot Study- Aim 3

University of Wisconsin (UW)

Status and phase

Completed

Early Phase 1

Conditions

Inflammation

Systemic Lupus Erythematosus

Treatments

Behavioral: App based mindfulness program (ABMP)

Study type

Interventional

Funder types

Other

Identifiers

NCT04857151

SMPH/PATHOL & LAB MED (Other Identifier)

PRJ66UV (Other Grant/Funding Number)

Protocol version 08/29/2023 (Other Identifier)

A536300 (Other Identifier)

2019-1173- Aim 3

Details and patient eligibility

About

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.

Enrollment

3 patients

Sex

Female

Ages

21 to 65 years old

Volunteers

No 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