Study of T-Regulatory Cells in Asthma

Study Overview
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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: To determine whether Treg number and function differs between obese and normal-weight individuals with and without asthma. To determine whether serum leptin levels differ between obese and normal-weight individuals with and without asthma.

Official Title
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Study of T-Regulatory Cells in Asthma

Conditions
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Asthma

Intervention / Treatment
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* Biological: blood draw, breathing test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: > 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| obese asthmatic<br>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. | Biological: blood draw, breathing test<br>* A blood draw,breathing test will be performed on every participant<br>|
| normal asthmatic<br>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 | Biological: blood draw, breathing test<br>* A blood draw,breathing test will be performed on every participant<br>|
| obese control<br>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. | Biological: blood draw, breathing test<br>* A blood draw,breathing test will be performed on every participant<br>|
| normal control<br>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. | Biological: blood draw, breathing test<br>* A blood draw,breathing test will be performed on every participant<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference of treg and serum leptin levels among obese and normal weight individuals with and without asthma. |  | 3 years |