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Predictive Medicine Research. (PRE MED)
This study is currently recruiting participants.
Verified by Emory University, October 2006
Sponsors and Collaborators: Emory University
Woodruff Foundation
Information provided by: Emory University
ClinicalTrials.gov Identifier: NCT00336570
  Purpose

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.


Condition
Cardiovascular Diseases

U.S. FDA Resources
Study Type: Observational
Study Design: Natural History, Cross-Sectional, Defined Population, Prospective Study
Official Title: Predictive Medicine Research (PRE MED) :Investigation of Predictors of Health, Sub-Clinical and Clinical Organ System Diseases in Healthy Adult Population.

Further study details as provided by Emory University:

Estimated Enrollment: 288
Study Start Date: February 2006
Estimated Study Completion Date: February 2009
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

  Eligibility

Ages Eligible for Study:   30 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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:

· 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00336570

Contacts
Contact: Arshed A Quyyumi, MD, FACP, FRCP 1-404-712-3655 aquyyum@emory.edu
Contact: Muhammad Amer, MD 1-404-712-0170 mamer@emory.edu

Locations
United States, Georgia
Emory University Hospital Recruiting
Atlanta, Georgia, United States, 30322
Principal Investigator: Arshed A Quyyumi, MD, FACP,FRCP            
Sponsors and Collaborators
Emory University
Woodruff Foundation
Investigators
Study Director: Muhammad Amer, MD Emory University
Study Director: Johnson Pereira Emory University
  More Information

Study ID Numbers: 6012
Study First Received: June 12, 2006
Last Updated: October 12, 2006
ClinicalTrials.gov Identifier: NCT00336570  
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Oxidative Stress
Endothelial Function
Flow Mediated Dilation

Study placed in the following topic categories:
Dilatation, Pathologic
Stress
Healthy

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009