AsthmaNCT00339703
Levels of Serum Resistin in Asthmatics as a Potential Marker of Systemic Inflammation and Disease State.
An observational study of Asthma, run by 59th Medical Wing at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- Type of treatment
- Pill or oral medicine
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2004to May 2006
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients enrolled to Wilford Hall Medical Center meeting the above eligibility criteria.
Who may be able to join
- Inclusion criteria for the asthmatic group will consist of the following: (a) male or non-pregnant female, (b) 18-65 years of age, (c) asthma defined as moderate or severe persistent by NHLBI guidelines, and characterized by at least daily symptoms, night symptoms at least once weekly, and a FEV1 between 60-80% of predicted. Newly diagnosed asthmatics, poorly controlled asthmatics, and hospitalized patients with asthma flares may also be considered in separate arms of this study.
- Inclusion criteria for the control group will consist of the following: (a) male or non-pregnant female, (b) 18-65 years of age.
Who cannot join
- 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.
- Exclusion criteria for the control group will consist of the following: (a) current use of oral steroids or statins, (b) prior diagnosis of asthma, or clinical symptoms consistent with asthma or reactive airway disease, (c) 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wilford Hall Medical Center
San Antonio, Texas, 78236
About this study
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.
Read the detailed description
Resistin is part of the FIZZ (found in inflammatory zones) family of genes, and was first characterized in murine models where it has been extensively studied as a potential link between type II diabetes and obesity. The murine FIZZ gene family consists of three related gene products: a)FIZZ-1 or Relm-a is found in adipocytes and lung tissue, b)FIZZ-2 or Relm-b found in the gastrointestinal tract, and c)FIZZ-3 or Resistin also found in adipocytes.1 Mouse models have shown resistin to be linked to obesity and insulin resistance, and thiazolidinedione has been shown to decrease resistin expression in mouse adipocytes.2 Distribution of the FIZZ gene products in humans is similar to mouse models: a)Relm-a is found in adipose, heart, and lung, b)Relm-b is found in the gastrointestinal tract, and c)Resistin is found in adipocytes and interestingly, is also found in circulating macrophages.3 Given the findings correlating obesity with diabetes in the mouse model, several studies were done in humans attempting to illustrate this same link. A study comparing middle age type II diabetics with matched controls found serum resistin levels to be increased in the diabetic group (16.6 vs 13.5, p<0.004), but this elevation was independent of adiposity, BMI, or insulin resistance. Elevation in C-reactive protein (CRP) in the diabetic group was the only factor that consistently correlated with elevation in resistin levels in this study.4 A second study comparing older (60-75 years of age) type II diabetics also found a significant elevation in serum resistin in the diabetic group that was independent of gender, insulin resistance, BMI, blood pressure, or total cholesterol. Interestingly, this study did find an association with plasma glucose concentration and serum resistin levels.5 Although there seems to be no direct link between resistin and insulin resistance in humans, the above data suggest a role for insulin in systemic inflammation commonly associated with diabetes. Adipocytes are known to be a source of inflammatory cytokines such as TNF-a and IL-6. TNF-a has been shown to be elevated in obesity, and many acute phase reactants and cytokines are associated with diabetes and the metabolic syndrome.6 In addition, resistin has been shown to induce VCAM-1, ICAM-1, and long pentraxin 3 (markers of vascular inflammation) in mouse models. The resistin related induction of VCAM-1 was partially blocked with a statin, indicating a role for resistin in vascular inflammation that may contribute to atherosclerosis and coronary artery disease seen in diabetics and the metabolic syndrome.7 Given the effects on vascular inflammation, resistin may be an important cytokine involved in a common inflammatory pathway seen in both diabetics and asthmatics.
Like diabetes, asthma is a disease marked by chronic inflammation. The inflammation associated with asthma has been predominantly illustrated in the airways, however, studies have shown that induced bronchoconstriction and asthma do illicit a systemic response with elevations in CRP thought to be mediated by IL-1, IL-6, and TNF-a via activated macrophages.8,9 In addition, CCL2 contributes to airway hyper-reactivity and cell migration, and thiazolidinedione has been shown to inhibit the IL-1b and TNF-a induced expression of CCL2 in the lung.10 Finally, a recent study illustrated an IL-4 and IL-13 induction of Relm-b via STAT-6 in response to allergic asthma.11 The level of serum resistin in human asthmatics is currently unknown, and may represent an important systemic marker of inflammation in this disease. Relating levels of serum resistin with disease state in conjunction with measurements of serum CRP and glucose would be an important aspect of further understanding the potential systemic inflammatory implications of asthma. In addition, unpublished data on exhaled NO have shown a positive correlation with asthma that could be used to further strengthen evidence of systemic inflammation with airway inflammation.
- Conditions
- Asthma
- Keywords
- Resistin, Asthma, CRP, Diabetes, FIZZ
- Medical subject headings
- Asthma, Diabetes Mellitus
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 |
|---|---|---|
| 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. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study startNov 2004
- Primary completionMay 2006
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- 59th Medical Wing
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Capt Jeffrey LaRochelle, USAF, MC, 59th Medical Wing
- Investigators
- Jeff S LaRochelle, MD, Principal investigator, United States Air Force
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00339703
- Sponsor's protocol ID
- FWH20040210H
- Status last verified
- Jan 2021
- First submitted
- 19 Jun 2006
- Last updated
- 19 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Levels of Serum Resistin in Asthmatics as a Potential Marker of Systemic Inflammation and Disease State.
- ClinicalTrials.gov ID
- NCT00339703
- Acronym / sponsor ID
- FWH20040210H
- Conditions
- Asthma
- Keywords
- Resistin, Asthma, CRP, Diabetes, FIZZ
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- 59th Medical WingUS federal agency
- Study start
- Nov 2004
- Primary completion
- May 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 21 Jun 2006 (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.
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.
Detailed description
Resistin is part of the FIZZ (found in inflammatory zones) family of genes, and was first characterized in murine models where it has been extensively studied as a potential link between type II diabetes and obesity. The murine FIZZ gene family consists of three related gene products: a)FIZZ-1 or Relm-a is found in adipocytes and lung tissue, b)FIZZ-2 or Relm-b found in the gastrointestinal tract, and c)FIZZ-3 or Resistin also found in adipocytes.1 Mouse models have shown resistin to be linked to obesity and insulin resistance, and thiazolidinedione has been shown to decrease resistin expression in mouse adipocytes.2 Distribution of the FIZZ gene products in humans is similar to mouse models: a)Relm-a is found in adipose, heart, and lung, b)Relm-b is found in the gastrointestinal tract, and c)Resistin is found in adipocytes and interestingly, is also found in circulating macrophages.3 Given the findings correlating obesity with diabetes in the mouse model, several studies were done in humans attempting to illustrate this same link. A study comparing middle age type II diabetics with matched controls found serum resistin levels to be increased in the diabetic group (16.6 vs 13.5, p<0.004), but this elevation was independent of adiposity, BMI, or insulin resistance. Elevation in C-reactive protein (CRP) in the diabetic group was the only factor that consistently correlated with elevation in resistin levels in this study.4 A second study comparing older (60-75 years of age) type II diabetics also found a significant elevation in serum resistin in the diabetic group that was independent of gender, insulin resistance, BMI, blood pressure, or total cholesterol. Interestingly, this study did find an association with plasma glucose concentration and serum resistin levels.5 Although there seems to be no direct link between resistin and insulin resistance in humans, the above data suggest a role for insulin in systemic inflammation commonly associated with diabetes. Adipocytes are known to be a source of inflammatory cytokines such as TNF-a and IL-6. TNF-a has been shown to be elevated in obesity, and many acute phase reactants and cytokines are associated with diabetes and the metabolic syndrome.6 In addition, resistin has been shown to induce VCAM-1, ICAM-1, and long pentraxin 3 (markers of vascular inflammation) in mouse models. The resistin related induction of VCAM-1 was partially blocked with a statin, indicating a role for resistin in vascular inflammation that may contribute to atherosclerosis and coronary artery disease seen in diabetics and the metabolic syndrome.7 Given the effects on vascular inflammation, resistin may be an important cytokine involved in a common inflammatory pathway seen in both diabetics and asthmatics.
Like diabetes, asthma is a disease marked by chronic inflammation. The inflammation associated with asthma has been predominantly illustrated in the airways, however, studies have shown that induced bronchoconstriction and asthma do illicit a systemic response with elevations in CRP thought to be mediated by IL-1, IL-6, and TNF-a via activated macrophages.8,9 In addition, CCL2 contributes to airway hyper-reactivity and cell migration, and thiazolidinedione has been shown to inhibit the IL-1b and TNF-a induced expression of CCL2 in the lung.10 Finally, a recent study illustrated an IL-4 and IL-13 induction of Relm-b via STAT-6 in response to allergic asthma.11 The level of serum resistin in human asthmatics is currently unknown, and may represent an important systemic marker of inflammation in this disease. Relating levels of serum resistin with disease state in conjunction with measurements of serum CRP and glucose would be an important aspect of further understanding the potential systemic inflammatory implications of asthma. In addition, unpublished data on exhaled NO have shown a positive correlation with asthma that could be used to further strengthen evidence of systemic inflammation with airway inflammation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients enrolled to Wilford Hall Medical Center meeting the above eligibility criteria.
Key inclusion criteria (2 listed)
- Inclusion criteria for the asthmatic group will consist of the following: (a) male or non-pregnant female, (b) 18-65 years of age, (c) asthma defined as moderate or severe persistent by NHLBI guidelines, and characterized by at least daily symptoms, night symptoms at least once weekly, and a FEV1 between 60-80% of predicted. Newly diagnosed asthmatics, poorly controlled asthmatics, and hospitalized patients with asthma flares may also be considered in separate arms of this study.
- Inclusion criteria for the control group will consist of the following: (a) male or non-pregnant female, (b) 18-65 years of age.
Key exclusion criteria (2 listed)
- 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.
- Exclusion criteria for the control group will consist of the following: (a) current use of oral steroids or statins, (b) prior diagnosis of asthma, or clinical symptoms consistent with asthma or reactive airway disease, (c) 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.
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
Not reported in the source record.
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 19 Jan 2021.
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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.
Jeff S LaRochelle, MD principal investigator
United States Air Force
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 Asthma, run by 59th Medical Wing 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 2 inclusion and 2 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 19 Jan 2021. 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.
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 19 Jan 2021.