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

Completed

• Conditions: Obesity; Overweight

• Registration Number: NCT02085759
• Lead Sponsor: West Penn Allegheny Health System

Brief Summary

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.

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 Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-05-28
• Primary Completion: 2010-12
• Status Verified: 2014-03
• Study First Submitted QC: 2014-03-11
• Last Update Submitted: 2014-03-11
• Study First Posted: 2014-03-13
• Last Update Posted: 2014-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Th2 Cytokine levels	Baseline (only visit)

Trial Locations

Locations (1)

Allegheny General Hospital, Dept. of Allergy, Asthma, & Immunology; 🇺🇸 Pittsburgh, Pennsylvania, United States