Study of T-Regulatory Cells in Asthma

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

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Biological: blood draw, breathing test

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 Type: Observational
• Enrollment (Actual): 66

Contacts and Locations

Study Locations

• United States
  • New York
    • New Hyde Park, New York, United States, 11040
      • North Shore Lij Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Females in good health between the ages of 18-50, with or without asthma.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Biological: blood draw, breathing test; 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	Biological: blood draw, breathing test; 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.	Biological: blood draw, breathing test; 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.	Biological: blood draw, breathing test; A blood draw,breathing test will be performed on every participant

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Northwell Health
• Investigators: Principal Investigator: Rubin Cohen, MD, North Shore

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: November 1, 2013
• First Submitted That Met QC Criteria: October 9, 2015
• First Posted (Estimate): October 12, 2015

Study Record Updates

• Last Update Posted (Estimate): January 29, 2016
• Last Update Submitted That Met QC Criteria: January 28, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 11-076B