OverweightNCT02085759
T-helper 2 (Th2) Cytokine Responses in Overweight/Obese Subjects
An observational study of Overweight and Obesity, run by West Penn Allegheny Health System at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- 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.
Who may be able to join
- adults aged 18 to 50 years
- pre-bronchodilator FEV1 > 80% predicted with no evidence of reversibility following administration of bronchodilator
- no history of allergies
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Allegheny General Hospital, Dept. of Allergy, Asthma, & Immunology
Pittsburgh, Pennsylvania, 15212
About this study
Official title: 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.
Read the 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.
- Conditions
- Overweight, Obesity
- Keywords
- Healthy
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Th2 Cytokine levels
Measured: Baseline (only visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2014 (estimated)
- Study startMay 2009
- Primary completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Penn Allegheny Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Pennsylvania Allergy and Asthma Research Foundation
- Responsible party
- Principal investigator, David Skoner, MD, West Penn Allegheny Health System
- Investigators
- David Skoner, MD, Principal investigator, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)Deborah Gentile, MD, Study director, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02085759
- Sponsor's protocol ID
- RC# 4729
- Status last verified
- Mar 2014
- First submitted
- 28 May 2009
- Last updated
- 13 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Th2 Cytokine Responses in Overweight/Obese Subjects
- ClinicalTrials.gov ID
- NCT02085759
- Acronym / sponsor ID
- RC# 4729
- Conditions
- Overweight, Obesity
- Keywords
- Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- West Penn Allegheny Health SystemUniversity, hospital or other
- Collaborators
- Pennsylvania Allergy and Asthma Research Foundation
- Study start
- May 2009
- Primary completion
- Dec 2010 (actual)
- First posted
- 13 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (3 listed)
- adults aged 18 to 50 years
- pre-bronchodilator FEV1 > 80% predicted with no evidence of reversibility following administration of bronchodilator
- no history of allergies
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Th2 Cytokine levels
Time frame: Baseline (only visit)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Skoner, MD principal investigator
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Deborah Gentile, MD study director
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overweight and Obesity, run by West Penn Allegheny Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Th2 Cytokine levels (time frame: Baseline (only visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2014.