Predictive Medicine Research
|ClinicalTrials.gov Identifier: NCT00384761|
Recruitment Status : Completed
First Posted : October 6, 2006
Last Update Posted : November 18, 2013
|Condition or disease||Phase|
|Atherosclerosis, Endothelial Dysfunction||Phase 1|
As a person ages their chance of developing certain diseases such as hardening of the arteries (atherosclerosis), diabetes, depression, osteoporosis and memory loss (Alzheimer's 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 cell's 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 Alzheimer's 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.
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 Type :||Observational|
|Actual Enrollment :||223 participants|
|Official Title:||Predictive Medicine Research: Investigation of Predictors of Health, Sub-clinical and Clinical Organ System Disease|
|Study Start Date :||March 2006|
|Primary Completion Date :||October 2010|
|Study Completion Date :||October 2010|
- Oxidative Stress [ Time Frame: Cross Sectional ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00384761
|United States, Georgia|
|Emory University Hospital|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Arshed Quyyumi, MD||Emory Hospital|
|Study Director:||Muhammad Amer, MD||Emory University|