|
Heart Disease Risk Factors in African Americans Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Heart Disease Risk Factors in African Americans conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Heart Disease Risk Factors in African Americans Clinical research trials and Heart Disease Risk Factors in African Americans health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Heart Disease Risk Factors in African Americans. Heart Disease Risk Factors in African Americans Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Heart Disease Risk Factors in African Americans clinical trial. Test subjects typically receive the most expert healthcare available for their Heart Disease Risk Factors in African Americans condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "H" Clinical Trials Conditions > Heart Disease Risk Factors in African Americans  Heart Disease Risk Factors in African Americans
Heart Disease Risk Factors in African Americans
For Condition: Coronary Disease,Obesity
Status: Recruiting
Sponsor(s): National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) ,
Synopsis: It is unknown if obesity contributes to the development of heart disease in African American men and women. This study was created to determine whether there is a relationship between sex and body size and the incidence of heart disease in African American men and women. Researchers will attempt to associate obesity with the presence of heart disease risk factors. Risk factors that will be studied include; total body fat, body fat distribution, fat content of the blood (triglyceride concentration, low density lipoproteins [LDL], and high density lipoproteins [HDL]), how fast fat is removed from the blood, and how well insulin works in the body. Scientific studies have shown that obesity and increased levels of fat content in the blood are important risk factors for heart disease in Caucasian women. However, similar studies in African American women have failed to show the same correlation. In fact, it appears that African American women in all three body weight groupings, nonobese, overweight, and obese experience high death rates due to heart disease. In addition, prior research has shown that obese African American men tend to have elevated levels of fat in the blood while African American women have normal blood fat levels. Therefore, if high levels of triglycerides (fat found in the blood) are not seen in non-diabetic obese African American women, it cannot be considered a risk factor in this population. This suggests that studies conducted on Caucasian women may not provide insight into heart disease risk factors in African American women. The study will take 120 healthy nondiabetic African American men and women (ages 18-50) grouped by sex (60 men and 60 women) and body mass index 3 subgroups; nonobese, overweight and obese). Diabetes undeniably increases the risk of heart disease. Therefore patients suffering from diabetes will not be included in the study. Candidates for the study will undergo a series of tests and examinations over 5 outpatient visits. Subjects will have body fat analyses, resting energy expenditure measurements, an EKG (electrocardiogram), and specific blood tests. Researchers believe this study will provide significant insight into the causes of obesity and heart disease in African Americans.
Details: This study is designed to investigate in African Americans the relationship of obesity to coronary artery disease risk factors, specifically fasting plasma triglyceride concentration and the triglyceride related risk factors of small dense low density lipoprotein (LDL), high density lipoprotein (HDL) and visceral fat. The Framingham Study has demonstrated that obesity and elevated triglyceride levels are important risk factors for coronary artery disease mortality in Caucasian women. However, studies that have had significant participation of African American women such as the Charleston Heart Study, have failed to show a relationship of obesity or central obesity to coronary artery disease mortality in African American women. In fact, it appears that African American women in all three body weight groupings, nonobese, overweight and obese experience high rates of mortality from coronary artery disease. Further our earlier research has demonstrated that obese African American men have elevated triglyceride levels but obese African American women have normal triglyceride levels. Consequently if elevated triglyceride levels do not occur in obese nondiabetic African American women, then elevated triglyceride levels can not represent a major cardiovascular risk for African American women. This suggests that studies of cardiovascular risk factors that have been carried out in predominantly Caucasian populations may not provide significant insight into cardiovascular risk for African Americans. The study, Heart Disease Risk Factors in African Americans, examines if there are differences by sex and body size in cardiovascular risk factors in African American men and women. We believe that obesity will be associated with a greater number and severity of cardiovascular risk factors in African American men. In contrast for African American women, cardiovascular risk factors that are etiologically linked to elevated triglyceride levels will not be magnified by obesity. Diabetes increases the risk of heart disease. Therefore diabetics will not be included in the study. Including diabetics would obscure the association between obesity and heart disease. This study will be a cross-sectional examination of 160 healthy, nondiabetic African American men and women (age range 18-50) grouped by sex (80 men and 80 women) and body mass index (3 subgroups: nonobese, overweight and obese). In a series of five outpatient visits to the NIH Clinical Center participants will have body fat analyses, resting energy expenditure measurements, an electrocardiogram, blood tests which include fasting lipid profiles, an oral glucose tolerance test, an intravenous glucose tolerance test, and postheparin lipoprotein lipase analysis. This study has the potential to provide significant insight into the pathophysiology of obesity and cardiovascular risk in African Americans.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: This is a study only of African Americans. Subjects will be allowed to participate if they self-identify as African Americans. The age range of the participants will be between 18 and 50 years. To participate in the study subjects should identify themselves as healthy. People with established coronary artery as evidenced by history of myocardial infarction, coronary artery bypass surgery or PTCA will be allowed to participate if they are not currently having angina. Women must give a history of regular monthly cycles (24-35 days) for at least one year. EXCLUSION CRITERIA: People that take medications that are known to alter the parameters which are under investigation in this study will be excluded. Subjects on thyroid hormone replacement will be included if their TSH is normal. Subjects taking oral contraceptives will not be enrolled. Subjects receiving antihypertensive medication will not be enrolled. All people with diabetes even if the diabetes is controlled with diet alone will not be enrolled in the study. Women must who are breastfeeding or have an infant that is less than four months of age will be excluded. Women with a history of irregular menstrual cycles in the year prior to the study will be excluded. Women in the following categories, regardless of age, will be excluded: history of hysterectomy, history of bilateral oophorectomy, use of Norplant or Depo-Provera for contraception. History of bleeding diathesis.
Total Enrollment: 242
Location and Contact Information:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 990002; 99-DK-0002
Study Start Date: October 6, 1998
Record last reviewed: September 26, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001853
Other Coronary Disease Studies:
1. Central Obesity and Disease Risk in Japanese Americans
2. Genomic Dissection of a QTL Affecting the Lipid Profile
3. Methods for Measuring Insulin Sensitivity
4. Genetic Determinants:Low HDL, High Triglycerides, Obesity
5. Obese Patients with Untreated Dyslipidemias
Related Studies:
Other Coronary Disease Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Heart Disease Risk Factors in African Americans
|
|
|
|
|
|
|
|
