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Study of T-Regulatory Cells in Asthma

NCT ID: NCT02574351

Last Updated: 2016-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

66 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-31

Study Completion Date

2015-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Asthma

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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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.

blood draw, breathing test

Intervention Type BIOLOGICAL

A blood draw,breathing test will be performed on every participant

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

blood draw, breathing test

Intervention Type BIOLOGICAL

A blood draw,breathing test will be performed on every participant

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.

blood draw, breathing test

Intervention Type BIOLOGICAL

A blood draw,breathing test will be performed on every participant

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.

blood draw, breathing test

Intervention Type BIOLOGICAL

A blood draw,breathing test will be performed on every participant

Interventions

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blood draw, breathing test

A blood draw,breathing test will be performed on every participant

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Northwell Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rubin Cohen, MD

Role: PRINCIPAL_INVESTIGATOR

North Shore

Locations

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North Shore LIJ Health System

New Hyde Park, New York, United States

Site Status

Countries

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United States

Other Identifiers

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11-076B

Identifier Type: -

Identifier Source: org_study_id