NCT00339703

Brief Summary

The purpose of this study is to determine whether serum resistin levels in asthmatics are elevated. We will recruit subjects from the allergy/immunology clinic with a prior diagnosis of moderate to severe persistent asthma in addition to subjects being seen for evaluation of drug allergies. Based on the inclusion and exclusion criteria below, subjects will be placed into a control and asthma group. Each subject will undergo one blood draw in the main lab at WHMC, and return a lavender top tube to the allergy/immunology clinic for the EIA resistin assay. The patient will then have a brief encounter with a physician to determine an up to date history of asthma symptoms prior to participating in the exhaled NO test. The entire subject encounter will take place with one clinic visit, and requires no follow up visits as part of the study. The greatest risk to each subject will be the blood draw, as the exhaled NO is a completely non-invasive test. Plasma from each subject will be stored in a -70° freezer for no more than one month. Samples will be analyzed for resistin levels using an EIA assay run monthly. Mean values from serum CRP, serum glucose, serum resistin, and exhaled NO will be compared using a students T-test.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2006

Completed
Last Updated

January 19, 2021

Status Verified

January 1, 2021

Enrollment Period

1.5 years

First QC Date

June 19, 2006

Last Update Submit

January 14, 2021

Conditions

Keywords

ResistinAsthmaCRPDiabetesFIZZ

Study Arms (2)

Control

Subjects between the ages of 18 and 65 without a diagnosis of asthma or other inflammatory disease were enrolled from the patient population at Wilford Hall Medical Center. Subjects underwent a single blood draw and spirometer.

Mild to Moderate Asthma

Subjects between the ages of 18 and 65, who were previously diagnosed with moderate to severe persistent asthma as defined by the National Asthma Education and Prevention Program (NAEPP), were enrolled from the Allergy and Immunology clinic at Wilford Hall Medical Center. Subjects on inhaled corticosteroids or other controller medications were allowed in the study, but subjects on oral corticosteroids were excluded. Subjects underwent a single blood draw and spirometer.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients enrolled to Wilford Hall Medical Center meeting the above eligibility criteria.

You may not qualify if:

  • Exlusion criteria for the asthmatic group will consist of the following: (a) current use of oral steroids or statins, (b) any serious concurrent disease process such as, but not limited to diabetes, coronary artery disease, or vasculitis, that would have effects on levels of systemic inflammation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wilford Hall Medical Center

San Antonio, Texas, 78236, United States

Location

MeSH Terms

Conditions

AsthmaDiabetes Mellitus

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Jeff S LaRochelle, MD

    United States Air Force

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

June 19, 2006

First Posted

June 21, 2006

Study Start

November 1, 2004

Primary Completion

May 1, 2006

Study Completion

May 1, 2006

Last Updated

January 19, 2021

Record last verified: 2021-01

Locations