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临床试验/NCT00336570
NCT00336570已完成不适用

Predictive Medicine Research (PRE MED) :Investigation of Predictors of Health, Sub-clinical and Clinical Organ System Diseases in Healthy Adult Population.

Emory University1 个研究点 分布在 1 个国家目标入组 288 人开始时间: 2006年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
288
试验地点
1

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Cross Sectional

入排标准

年龄范围
30 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • · 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>
  • Fasting Glucose>
  • BP >135/85 on 3 repeated measures.
  • Current smoker or smoker in the last 5 years.
  • History of depression.
  • Inability to give informed consent.

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Arshed A. Quyyumi

Professor

Emory University

研究点 (1)

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Predictive Medicine Research. (PRE MED) | 临床试验