Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

New Hyde Park, New York 11040


Purpose:

To study whether the immune response as directed by regulatory T cells is different between obese asthmatics, normal weight asthmatics and healthy controls.


Study summary:

The investigators hypothesize that the increase in asthma severity in obese patients is, at least in part, related to a defective number or function of regulatory T cells (Tregs). That is in the obese asthmatic subject a defective Treg profile would augment the inflammation of asthma (a synergistic effect). Alternatively, that Treg dysfunction in obesity might affect asthma independently (an additive effect). To test these hypotheses, the investigators plan to conduct an observational controlled study to compare Treg profile in obese and normal-weight individuals with and without asthma. This is an exploratory study to investigate the following: 1. To determine whether Treg number and function differs between obese and normal-weight individuals with and without asthma. 2. To determine whether serum leptin levels differ between obese and normal-weight individuals with and without asthma.


Criteria:

Inclusion Criteria: 1. Obese asthmatics 2. Normal weight asthmatics 3. Healthy obese 4. Health non-obese Asthmatic subjects will be recruited: 1. If they have a physician diagnosis of adult onset asthma (asthma diagnosed after the age of 18). 2. 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 1. Will not have had a prior diagnosis of asthma, 2. Have no history of atopy. 3. Have no history of lung diseases. Exclusion Criteria: 1. > 10 pack year smoking history, or currently smoking 2. Pulmonary disease other than asthma. 3. History of heart disease 4. Weight loss greater than 10 kg, or greater than 10% initial body weight within the past 3 months. 5. Any agents that could potentially alter the inflammatory system such as thiazolidinedione, a statin, or oral steroid therapy.


Study is Available At:


Original ID:

11-076B


NCT ID:

NCT02574351


Secondary ID:


Study Acronym:


Brief Title:

Study of T-Regulatory Cells in Asthma


Official Title:

Study of T-Regulatory Cells in Asthma


Overall Status:

Completed


Study Phase:

N/A


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

50 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

North Shore Long Island Jewish Health System


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Time Perspective: Prospective


Number of Arms:

0


Number of Groups:

4


Total Enrollment:

66


Enrollment Type:

Actual


Overall Contact Information

Official Name:Rubin Cohen, MD
Principal Investigator
North Shore

Study Dates

Start Date:May 2011
Completion Date:December 2015
Completion Type:Actual
Primary Completion Date:December 2015
Primary Completion Type:Actual
Verification Date:January 2016
Last Changed Date:January 28, 2016
First Received Date:November 1, 2013

Study Outcomes

Outcome Type:Primary Outcome
Measure:Difference of treg and serum leptin levels among obese and normal weight individuals with and without asthma.
Time Frame:3 years
Safety Issues:False

Study Interventions

Intervention Type:Biological
Name:blood draw, breathing test
Description:A blood draw,breathing test will be performed on every participant
Arm Name:obese asthmatic

Study Arms

Study Arm Type:Other
Arm Name:normal control
Description: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.
Study Arm Type:Other
Arm Name:obese control
Description: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.
Study Arm Type:Other
Arm Name:normal asthmatic
Description: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
Study Arm Type:Other
Arm Name:obese asthmatic
Description: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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:North Shore Long Island Jewish Health System

Samples and Retentions

Sample Retention:Samples Without DNA
Description: T regulatory cells are isolated in the blood specimens
Study Population: Females in good health between the ages of 18-50, with or without asthma.
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.