Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00339703
Status:
COMPLETED
Last Update Posted:
2021-01-19
First Post:
2006-06-19
Brief Title:
Levels of Serum Resistin in Asthmatics as a Potential Marker of Systemic Inflammation and Disease State
Sponsor:
59th Medical Wing
Organization:
59th Medical Wing
Study Overview
Official Title:
Levels of Serum Resistin in Asthmatics as a Potential Marker of Systemic Inflammation and Disease State
Status:
COMPLETED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether serum resistin levels in asthmatics are elevated We will recruit subjects from the allergyimmunology 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 allergyimmunology 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
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 aFIZZ-1 or Relm-a is found in adipocytes and lung tissue bFIZZ-2 or Relm-b found in the gastrointestinal tract and cFIZZ-3 or Resistin also found in adipocytes1 Mouse models have shown resistin to be linked to obesity and insulin resistance and thiazolidinedione has been shown to decrease resistin expression in mouse adipocytes2 Distribution of the FIZZ gene products in humans is similar to mouse models aRelm-a is found in adipose heart and lung bRelm-b is found in the gastrointestinal tract and cResistin is found in adipocytes and interestingly is also found in circulating macrophages3 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 166 vs 135 p0004 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 study4 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 levels5 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 syndrome6 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 syndrome7 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 macrophages89 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 lung10 Finally a recent study illustrated an IL-4 and IL-13 induction of Relm-b via STAT-6 in response to allergic asthma11 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
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 macrophages89 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 lung10 Finally a recent study illustrated an IL-4 and IL-13 induction of Relm-b via STAT-6 in response to allergic asthma11 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None