Status:
COMPLETED
Stress, Inflammation and Immune Response Pilot Study- Aim 3
Lead Sponsor:
University of Wisconsin, Madison
Conditions:
Systemic Lupus Erythematosus
Inflammation
Eligibility:
FEMALE
21-65 years
Phase:
EARLY_PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2024
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04857151
Start Date
February 2 2022
End Date
March 31 2024
Last Update
May 16 2024
Active Locations (1)
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1
University of Wisconsin
Madison, Wisconsin, United States, 53705