Predictive Medicine Research

This study has been completed.
Sponsor:
Collaborator:
The Robert W. Woodruff Foundation
Information provided by (Responsible Party):
Arshed A. Quyyumi, Emory University
ClinicalTrials.gov Identifier:
NCT00384761
First received: October 3, 2006
Last updated: November 15, 2013
Last verified: November 2013
  Purpose

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 Phase
Atherosclerosis, Endothelial Dysfunction
Phase 1

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Predictive Medicine Research: Investigation of Predictors of Health, Sub-clinical and Clinical Organ System Disease

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Oxidative Stress [ Time Frame: Cross Sectional ] [ Designated as safety issue: No ]

Enrollment: 223
Study Start Date: March 2006
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Healthy Individuals between ages 20-90

Criteria

Inclusion Criteria:

  • Ages 20-90+
  • 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:

  • Age <30
  • Any oral antioxidants in the previous 2 weeks
  • On lipid lowering medication in the past 8 weeks
  • History of substance abuse
  • Current cancer or history of cancer except basal cell cancer
  • Any heart disease except for corrected congenital ht disease
  • History of neurological disease
  • History of chronic GI disorders
  • History of inflammatory joint disorders
  • Known endocrine disorders
  • History of Chronic Pulmonary diseases e.g. COPD
  • Acute illness such as infection in the previous 4 weeks
  • Creatinine > 2
  • Liver enzymes >1.5X normal
  • Anemia (Hemoglobin < 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

For more information or patient referral call Johnson Pereira 404-275-0034, Rajinder Grover 404-686-7063, Muhammad Amer 404-805-4771 or Salman Sher 404-587-2667

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00384761

Locations
United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
The Robert W. Woodruff Foundation
Investigators
Principal Investigator: Arshed Quyyumi, MD Emory Hospital
Study Director: Muhammad Amer, MD Emory University
  More Information

Publications:
Responsible Party: Arshed A. Quyyumi, Professor, Emory University
ClinicalTrials.gov Identifier: NCT00384761     History of Changes
Other Study ID Numbers: IRB00024767a, PreMed 6012, 1190-2005
Study First Received: October 3, 2006
Last Updated: November 15, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 19, 2014