Clinical trial NCT02085759: T-helper 2 (Th2) Cytokine Responses in Overweight/Obese Subjects
Official title: Th2 Cytokine Responses in Overweight/Obese Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overweight
Obesity
Keywords: Healthy
Lead sponsor: West Penn Allegheny Health System
Sponsor class: OTHER
Collaborators: name: Pennsylvania Allergy and Asthma Research Foundation
First posted: 2014-03-13
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Th2 Cytokine levels
timeFrame: Baseline (only visit)
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Allegheny General Hospital, Dept. of Allergy, Asthma, & Immunology
state: Pennsylvania
Study officials:
affiliation: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
name: David Skoner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
name: Deborah Gentile, MD
role: STUDY_DIRECTOR
References: