Study of T-Regulatory Cells in Asthma
1 other identifier
observational
66
1 country
1
Brief Summary
To study whether the immune response as directed by regulatory T cells is different between obese asthmatics, normal weight asthmatics and healthy controls.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2011
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 1, 2013
CompletedFirst Posted
Study publicly available on registry
October 12, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedJanuary 29, 2016
January 1, 2016
4.6 years
November 1, 2013
January 28, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Difference of treg and serum leptin levels among obese and normal weight individuals with and without asthma.
3 years
Study Arms (4)
obese asthmatic
Participants from this group will be included in this study. A blood draw, breathing test will be performed to see if there is a difference in the t-regulatory cells amongst this group.
normal asthmatic
Participants from this group will be included in this study. A blood draw, breathing test will be performed to see if there is a difference in the t-regulatory cells amongst this group
obese control
Participants from this group will be included in this study. A blood draw, breathing test will be performed to see if there is a difference in the t-regulatory cells amongst this group.
normal control
Participants from this group will be included in this study. A blood draw, breathing test will be performed to see if there is a difference in the t-regulatory cells amongst this group.
Interventions
A blood draw,breathing test will be performed on every participant
Eligibility Criteria
Females in good health between the ages of 18-50, with or without asthma.
You may qualify if:
- Obese asthmatics
- Normal weight asthmatics
- Healthy obese
- Health non-obese
- Asthmatic subjects will be recruited:
- If they have a physician diagnosis of adult onset asthma (asthma diagnosed after the age of 18).
- If they have stable disease without exacerbation, physician or emergency department visits, or change in asthma medication for the past 4 weeks, inhaled steroids will be allowed.
- Non asthmatic subjects
- Will not have had a prior diagnosis of asthma,
- Have no history of atopy.
- Have no history of lung diseases.
You may not qualify if:
- \> 10 pack year smoking history, or currently smoking
- Pulmonary disease other than asthma.
- History of heart disease
- Weight loss greater than 10 kg, or greater than 10% initial body weight within the past 3 months.
- Any agents that could potentially alter the inflammatory system such as thiazolidinedione, a statin, or oral steroid therapy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Northwell Healthlead
Study Sites (1)
North Shore LIJ Health System
New Hyde Park, New York, 11040, United States
Biospecimen
T regulatory cells are isolated in the blood specimens
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rubin Cohen, MD
North Shore
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 2013
First Posted
October 12, 2015
Study Start
May 1, 2011
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
January 29, 2016
Record last verified: 2016-01