Skip to content

Study of T-Regulatory Cells in Asthma

Study of T-Regulatory Cells in Asthma

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02574351
Enrollment
66
Registered
2015-10-12
Start date
2011-05-31
Completion date
2015-12-31
Last updated
2016-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

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.

Interventions

BIOLOGICALblood draw, breathing test

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

Sponsors

Northwell Health
Lead SponsorOTHER

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
Difference of treg and serum leptin levels among obese and normal weight individuals with and without asthma.3 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026