Ignite Creation Date:
2024-05-05 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00384761
Status:
COMPLETED
Last Update Posted:
2013-11-18
First Post:
2006-10-03
Brief Title:
Predictive Medicine Research
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Predictive Medicine Research Investigation of Predictors of Health Sub-clinical and Clinical Organ System Disease
Status:
COMPLETED
Status Verified Date:
2013-11
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:
To establish normal values by age race and gender of novel markers of risk in healthy subjects necessary to predict precise risk of cardiovascular disease in an individual
Detailed Description:
Introduction
As a person ages their chance of developing certain diseases such as hardening of the arteries atherosclerosis diabetes depression osteoporosis and memory loss Alzheimers disease increases One of the theories that might explain why age increases the risk of developing these diseases involves a concept called oxidative stress Oxidative stress is a process that occurs inside the cells in our body All the cells in our body are constantly undergoing various biochemical reactions which are important to the cells life cycle Byproducts of these biochemical reactions are molecules called free radicals or pro-oxidants Pro-oxidants can be very damaging to the cell and lead to cell death Cells also have molecules called antioxidants which neutralize the pro-oxidants and protect the cell so it can continue functioning normally Oxidative stress occurs when there is an imbalance in the pro-oxidants as compared with the antioxidants Other studies have shown that diseases such as hardening of the arteries depression osteoporosis and Alzheimers are associated with elevated levels of free radicals or pro-oxidants inside the cells It is now possible to measure the levels of pro-oxidants in the cells using blood tests
Objectives
The purpose of this study is to determine how reliable and reproducible these measurements are and also to define a normal value or range of values in healthy people It is our hope that after we are able to define the normal range of values for oxidative stress we can then look at people with the aforementioned diseases and measure their levels of oxidative stress looking for a correlation between the two If we can show a direct correlation between level of oxidative stress and these diseases we can begin trying to develop medicines that can target this area and hopefully prevent or lessen the degree of these diseases
Tests and Evaluations
In this study we are looking for healthy participants age 30 and older who will undergo blood tests that will allow us to measure markers of oxidative stress Participants will also undergo tests specifically designed to look for evidence of early multi-organ disease These exams will include an evaluation of lung function spirometry test exercise capacity using a stationary bike bone density scan looking for osteoporosis ultrasound of the artery of the neck carotid and artery of the arm brachial nerve conduction study bio-impedance Body fact composition and several questionnaires to assess memory and mood The participants require one screening visit and a follow up visit to undergo the tests
As a person ages their chance of developing certain diseases such as hardening of the arteries atherosclerosis diabetes depression osteoporosis and memory loss Alzheimers disease increases One of the theories that might explain why age increases the risk of developing these diseases involves a concept called oxidative stress Oxidative stress is a process that occurs inside the cells in our body All the cells in our body are constantly undergoing various biochemical reactions which are important to the cells life cycle Byproducts of these biochemical reactions are molecules called free radicals or pro-oxidants Pro-oxidants can be very damaging to the cell and lead to cell death Cells also have molecules called antioxidants which neutralize the pro-oxidants and protect the cell so it can continue functioning normally Oxidative stress occurs when there is an imbalance in the pro-oxidants as compared with the antioxidants Other studies have shown that diseases such as hardening of the arteries depression osteoporosis and Alzheimers are associated with elevated levels of free radicals or pro-oxidants inside the cells It is now possible to measure the levels of pro-oxidants in the cells using blood tests
Objectives
The purpose of this study is to determine how reliable and reproducible these measurements are and also to define a normal value or range of values in healthy people It is our hope that after we are able to define the normal range of values for oxidative stress we can then look at people with the aforementioned diseases and measure their levels of oxidative stress looking for a correlation between the two If we can show a direct correlation between level of oxidative stress and these diseases we can begin trying to develop medicines that can target this area and hopefully prevent or lessen the degree of these diseases
Tests and Evaluations
In this study we are looking for healthy participants age 30 and older who will undergo blood tests that will allow us to measure markers of oxidative stress Participants will also undergo tests specifically designed to look for evidence of early multi-organ disease These exams will include an evaluation of lung function spirometry test exercise capacity using a stationary bike bone density scan looking for osteoporosis ultrasound of the artery of the neck carotid and artery of the arm brachial nerve conduction study bio-impedance Body fact composition and several questionnaires to assess memory and mood The participants require one screening visit and a follow up visit to undergo the tests
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1190-2005 | OTHER | Other | None |
| PreMed 6012 | OTHER | None | None |