Examining the Link Between Trace Elements and Cardiovascular Disease Risk Factors in Young Adults

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Ka He, MD, MPH, ScD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00318734
First received: April 25, 2006
Last updated: December 9, 2011
Last verified: December 2011
  Purpose

Cardiovascular disease (CVD) affects millions of people in the United States; each year, more people die from CVD than from any other disease. There are many dietary and lifestyle factors that may increase the risk of developing CVD. Preliminary research has shown that the presence of certain trace elements may be associated with the development of CVD. This study will examine toenail clippings and laboratory data to evaluate the link between trace elements and CVD risk factors in young adults.


Condition
Cardiovascular Diseases
Metabolic Syndrome X
Hypertension
Inflammation
Atherosclerosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Trace Elements and CVD Risk Factors Among Young Adults

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • CVD risk factors [ Time Frame: 1987-2010 ] [ Designated as safety issue: No ]

Enrollment: 4362
Study Start Date: May 2006
Study Completion Date: April 2011
Detailed Description:

CVD is a disorder that affects the heart's ability to function normally. The most common cause of heart disease is narrowing or blockage of the coronary arteries, which supply blood to the heart. There are many risk factors for CVD, including inflammation, high blood pressure, high cholesterol, and obesity. Small quantities of trace elements, also known as micronutrients, are essential in maintaining a healthy body. Research has shown that some trace elements may be associated with the development of CVD, but more research is needed to confirm this connection. This study will examine concentrations of several trace elements in toenail samples of young adults participating in the Coronary Artery Risk Development in Young Adults (CARDIA) study. The CARDIA study is measuring changes in CVD risk factors in individuals as they age and is identifying lifestyle habits that influence those changes. The purpose of this study is to determine the link between trace elements and CVD risk factors in young adults. The results of this study may help to identify whether dietary, lifestyle, or environmental factors can be modified at a young age to prevent the development of CVD.

This study will examine laboratory and medical history data of participants who are already enrolled in the CARDIA study; there are no additional study visits specifically for this study. Toenail samples collected from participants during their Year 2 CARDIA study visit in the late 1980's will be examined to determine the presence of selenium, chromium, arsenic, and mercury. Participants' CARDIA study data will be reviewed and several CVD risk factors will be analyzed, including the thickness of heart arteries; calcium buildup within the arteries; inflammatory markers, such as high sensitivity C-reactive protein and interleukin 6; blood pressure levels; body weight; and levels of cholesterol, fat, and sugar.

  Eligibility

Ages Eligible for Study:   20 Years to 32 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Participating in the CARDIA study.

Criteria

Inclusion Criteria:

  • Enrolled in the CARDIA study; this current study will be using existing CARDIA study data and will not be recruiting any new participants
  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: NCT00318734

Locations
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7461
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Ka He, MD University of North Carolina, Chapel Hill
  More Information

No publications provided

Responsible Party: Ka He, MD, MPH, ScD, Associate Professor of Nutrition and Epidemiology, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00318734     History of Changes
Other Study ID Numbers: 1335, R01HL081572-01A1, R01 HL081572-01A1
Study First Received: April 25, 2006
Last Updated: December 9, 2011
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Arteriosclerosis
Atherosclerosis
Cardiovascular Diseases
Hypertension
Inflammation
Metabolic Syndrome X
Arterial Occlusive Diseases
Glucose Metabolism Disorders
Hyperinsulinism
Insulin Resistance
Metabolic Diseases
Pathologic Processes
Vascular Diseases
Micronutrients
Trace Elements
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014