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

NCT02085759 | Completed

• 1 other identifier: RC# 4729
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight; Obesity

Keywords

Healthy

Outcome Measures

Primary Outcomes (1)

• Th2 Cytokine levels

  Baseline (only visit)

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• West Penn Allegheny Health System: lead
• Pennsylvania Allergy and Asthma Research Foundation: collaborator

Study Sites (1)

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

Pittsburgh, Pennsylvania, 15212, United States

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• David Skoner, MD

  Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

  PRINCIPAL INVESTIGATOR

• Deborah Gentile, MD

  Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Allergy and Asthma Institute

Study Record Dates

• First Submitted: May 28, 2009
• First Posted: March 13, 2014
• Study Start: May 1, 2009
• Primary Completion: December 1, 2010
• Last Updated: March 13, 2014

Record last verified: 2014-03

Locations

US (1)