Study of T-Regulatory Cells in Asthma

Completed

• Conditions: Asthma
• Interventions: Biological: blood draw, breathing test

• Registration Number: NCT02574351
• Lead Sponsor: Northwell Health

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.

Detailed Description

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.

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2013-11-01
• Study First Submitted QC: 2015-10-09
• Study First Posted: 2015-10-12
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-28
• Last Update Posted: 2016-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 66

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
obese control	blood draw, breathing test	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	blood draw, breathing test	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 asthmatic	blood draw, breathing test	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	blood draw, breathing test	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

Primary Outcome Measures

Name	Time	Method
Difference of treg and serum leptin levels among obese and normal weight individuals with and without asthma.	3 years

Trial Locations

Locations (1)

North Shore LIJ Health System; 🇺🇸 New Hyde Park, New York, United States