T-helper 2 (Th2) Cytokine Responses in Overweight/Obese S... | NCT02085759

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

NCT02085759

Sponsor

West Penn Allegheny Health System

Status

Completed

Last Update Posted

Mar 13, 2014Estimated

Enrollment

46Actual

Phase

Not provided

Conditions

Overweight
Obesity

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2009

Primary Completion Date

Dec 2010Actual

Completion Date

Not provided

First Submitted Date

May 28, 2009

First Submission Date that Met QC Criteria

Mar 11, 2014

First Posted Date

Mar 13, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 11, 2014

Last Update Posted Date

Mar 13, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

David Skoner, MD, Director, Allergy and Asthma Institute, West Penn Allegheny Health SystemPrincipal Investigator

Lead Sponsor

West Penn Allegheny Health SystemOTHER

Collaborators

Name	Class
Pennsylvania Allergy and Asthma Research Foundation	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

46Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Measure	Description	Time Frame
Th2 Cytokine levels		Baseline (only visit)

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Allegheny General Hospital, Dept. of Allergy, Asthma, & Immunology		Pittsburgh	Pennsylvania	15212	United States

Condition Browse Module

MeSH Terms

ID	Term
D050177	Overweight
D009765	Obesity

Ancestor Terms

ID	Term
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight

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Browse Branches

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