T-helper 2 (Th2) Cytokine Responses in Overweight/Obese Subjects

March 11, 2014 updated by: David Skoner, MD, West Penn Allegheny Health System

Th2 Cytokine Responses in Overweight/Obese Subjects

Cytokines are chemicals that are naturally made by your body. Certain cytokine levels are changed in the blood of patients who develop allergies and/or asthma. Cytokine levels may also be changed in some individuals who are overweight or obese. The purpose of this study is to determine if certain cytokine levels differ based on a person's weight and whether or not they have allergies or asthma. Information gathered in this study will be compared to information gathered from subjects who have participated in another similar study for patients who have allergies and/or asthma.

Study Overview

Status

Completed

Conditions

Detailed Description

The aims of this study are to:

  1. Characterize the relationship between BMI and Th2 skewing in non-atopic adult subjects.
  2. Compare these results to those previously obtained from atopic adult subjects It is expected that the results of this study will demonstrate enhanced Th2 skewing in overweight and obese atopic subjects as compared to non-atopic subjects. It is further anticipated that the results of this study will be used as preliminary data to generate an NIH grant application exploring the link between obesity and atopy.

Study Type

Observational

Enrollment (Actual)

46

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny General Hospital, Dept. of Allergy, Asthma, & Immunology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects will be male or female, aged 18-50 years, and of any race. Subjects must be healthy with no history of allergies or asthma. Subjects will be placed in one of three groups based on their BMI: normal, overweight, or obese.

Description

Inclusion Criteria:

  • adults aged 18 to 50 years
  • pre-bronchodilator FEV1 > 80% predicted with no evidence of reversibility following administration of bronchodilator
  • no history of allergies

Exclusion Criteria:

  • medical history consistent with atopy and/or asthma
  • any positive response to allergy skin testing for inhalant allergens (defined as a wheal > 3 mm larger than the negative control)
  • a pre-bronchodilator FEV1 < 80% predicted
  • > 12% reversibility in FEV1 following administration of a bronchodilator
  • any history of significant chronic illness
  • history of respiratory infection within the past 2 weeks
  • any use of prescription medications other than oral contraceptives or thyroid hormone replacement within the past 2 months
  • use of any investigational medication within the past month

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Normal BMI
Subjects with a BMI range of 18.5 to 24.9 which is defined by the CDC as within normal range.
Overweight BMI
Subjects with a BMI of 25.0 to 29.9 are defined by the CDC as being overweight.
Obese BMI
Subjects with a BMI of 30.0 and above are defined by the CDC as being obese.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Th2 Cytokine levels
Time Frame: Baseline (only visit)
Baseline (only visit)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West Penn Allegheny Health System

Collaborators

Pennsylvania Allergy and Asthma Research Foundation

Investigators

  • Principal Investigator: David Skoner, MD, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
  • Study Director: Deborah Gentile, MD, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

May 28, 2009

First Submitted That Met QC Criteria

March 11, 2014

First Posted (Estimate)

March 13, 2014

Study Record Updates

Last Update Posted (Estimate)

March 13, 2014

Last Update Submitted That Met QC Criteria

March 11, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC# 4729

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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