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Completed

NCT Number: NCT02085759

T-helper 2 (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.

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Key information

Conditions

Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Allegheny General Hospital, Dept. of Allergy, Asthma, & Immunology

Pittsburgh, Pennsylvania, 15212, United States

About this study

The aims of this study are to:

  • Characterize the relationship between BMI and Th2 skewing in non-atopic adult subjects.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Primary outcomes

  1. Th2 Cytokine levels

    Time frame: Baseline (only visit)

Sponsors and collaborators

Lead sponsor

West Penn Allegheny Health System

Other

Collaborators

  • Pennsylvania Allergy and Asthma Research Foundation

Registry information

Official study title

Th2 Cytokine Responses in Overweight/Obese Subjects

Important dates

Study start
2009
Primary completion
2010
First posted
Mar 13, 2014
Registry last updated
Mar 13, 2014

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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