Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
288 participants
OBSERVATIONAL
2006-02-28
2010-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
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.
For more information or patient referral call Johnson Periera 404-275-0034, Muhammad Amer 404-805-4771 or Salman Sher 404-587-2667
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
ECOLOGIC_OR_COMMUNITY
CROSS_SECTIONAL
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Healthy normal performance status.
* LDL cholesterol level \<120 mg/dl
* Fasting blood glucose \<99 mg/dL
* Blood pressure \<135 mmHg systolic and \<85 mmHg diastolic
* Non-smoker for at least 5 years
* BMI \>19 and \<26; stable body weight
* Free of neurological and psychological (Axis I) disorders for at least three years.
Exclusion Criteria
* On lipid lowering medication in the past 8 weeks.
* History of substance abuse.
* Current neoplasm or history of neoplasia except basal cell cancer.
* Any heart disease except for corrected congenital ht disease. History of neurological disease.
* History of chronic GI disorders.
* History of Rheumatologic disorders.
* Known endocrine disorders.
* History of Chronic Pulmonary diseases eg. COPD
* Acute illness such as infection in the previous 4 weeks.
* Creatinine \> 2
* Liver enzymes \>1.5X normal.
* Anemia (Hb \< 12.5) or chronic hematological disorder.
* Physical limitation and sedentary status for any reason.
* LDL cholesterol\>120.
* Fasting Glucose\>99.
* BP \>135/85 on 3 repeated measures.
* Current smoker or smoker in the last 5 years.
* History of depression.
* Inability to give informed consent.
* Age \<30
30 Years
90 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The Robert W. Woodruff Foundation
OTHER
Emory University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Arshed A. Quyyumi
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Arshed A Quyyumi, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Emory University Hospital
Atlanta, Georgia, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Jarrell ZR, Smith MR, Hu X, Orr M, Liu KH, Quyyumi AA, Jones DP, Go YM. Plasma acylcarnitine levels increase with healthy aging. Aging (Albany NY). 2020 Jun 16;12(13):13555-13570. doi: 10.18632/aging.103462. Epub 2020 Jun 16.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
6012
Identifier Type: OTHER
Identifier Source: secondary_id
IRB00024767
Identifier Type: -
Identifier Source: org_study_id