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OpenTrials
Completed

NCT Number: NCT02574351

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

North Shore LIJ Health System

New Hyde Park, New York, 11040, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

blood draw, breathing test

Biological

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

Primary outcomes

  1. Difference of treg and serum leptin levels among obese and normal weight individuals with and without asthma.

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Registry information

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Oct 12, 2015
Registry last updated
Jan 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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