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

Obesity Clinical Trial

Official title:

Th2 Cytokine Responses in Overweight/Obese Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02085759
• Other study ID #: RC# 4729
• Status: Completed
• Phase: N/A
• First received: May 28, 2009
• Last updated: March 11, 2014
• Start date: May 2009

Study information

• Verified date: March 2014
• Source: West Penn Allegheny Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Obesity
• Overweight

Locations

Country	Name	City	State
United States	Allegheny General Hospital, Dept. of Allergy, Asthma, & Immunology	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
West Penn Allegheny Health System	Pennsylvania Allergy and Asthma Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Th2 Cytokine levels		Baseline (only visit)	No