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CompletedNCT00336570Updated Nov 18, 2013

Predictive Medicine Research. (PRE MED)

An observational study in Cardiovascular Diseases, sponsored by Emory University. Completed at 1 site in United States. Open to participants aged 30 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-11-18.

Sponsored by Emory University · Observational

Study type
Observational
Model
Ecologic or community
Time perspective
Cross-sectional
Enrollment
288
Ages
30 Years to 90 Years
Sex
All
01

Study summary

Principal Investigator: Arshed A. Quyyumi, MD

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.

Read the 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 (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

02

Conditions studied

  • Cardiovascular Diseases

Keywords

  • Oxidative Stress
  • Endothelial Function
  • Flow Mediated Dilation
03

In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.

This study's enrollment of 288 is below the median of 573 across 1,485 observational studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

Emory University is the lead sponsor of 1,386 studies on the registry; 236 are open to participants now.

Of its 229 completed or terminated interventional studies of FDA-regulated products, 174 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
30 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Healthy normal subjects between the ages of 30-90.

Inclusion criteria

  • Ages 30-90.
  • 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

Exclusion Criteria:

  • Any oral antioxidants in the previous 2 weeks.
  • 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
05

Study design

Observational model
Ecologic or community
Time perspective
Cross-sectional
Enrollment
288 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna
06

Study locations

1 site
  • Emory University Hospital
    Atlanta, Georgia 30322, United States
07

References and documents

Publications

  • 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. PubMed 32554854 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00336570
Lead sponsor
Emory University
Collaborators
The Robert W. Woodruff Foundation
Responsible party
Arshed A. Quyyumi (Professor, Emory University) — Principal investigator
First posted
Jun 14, 2006
Start date
Feb 2006
Completion
Oct 2010
Last update
Nov 18, 2013

Study contacts

Arshed A Quyyumi, MD
principal investigator · Emory University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.

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