Diabetes and Heart Disease Risk in Blacks
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|ClinicalTrials.gov Identifier: NCT00001853|
Recruitment Status : Recruiting
First Posted : November 4, 1999
Last Update Posted : October 22, 2020
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.
|Condition or disease|
|Cardiovascular Diabetes Obesity Hypertension|
This study is designed to investigate in blacks the relationship of risk for diabetes and heart disease from obesity plasma glucose and triglyceride concentrations and the triglyceride related risk factors of small dense low density lipoprotein (LDL), high density lipoprotein (HDL) and central obesity.
The Framingham Study demonstrated that obesity and elevated glucose and triglyceride levels are important risk factors for coronary artery disease in white women. However, studies that have had significant participation of black women such as the Charleston Heart Study, failed to show a relationship of obesity or triglyceride to coronary artery disease mortality in black women. In fact, black women independent of body weight or triglyceride levels experience high mortality from coronary artery disease. Our earlier research has demonstrated that obese black men have elevated triglyceride levels but obese black women have normal triglyceride levels. Consequently if elevated triglyceride levels do not occur in obese nondiabetic black women, then elevated triglyceride levels may not represent a major cardiovascular risk for black women.
The study, Diabetes and Heart Disease Risk in Blacks, is designed to determine the role of obesity, glucose and triglyceride on risk for heart disease in blacks. For this study of blacks, we will study 2 groups, African Americans and Black Africans living in the United States. African Americans must self-identify as African American, be born in the United States and have parents who self-identify as African American and were born in the United States. The second group will be blacks living in the United States but were born in Africa and whose parents were born in Africa.
We will recruit 1132 healthy, non-diabetic individuals (546 men, 586 women), age range 18-65, and body mass index (3 subgroups: nonobese, overweight and obese). We need to recruit more women than men because triglyceride and glucose levels are lower in women than men. Therefore a larger number of women are needed to see an effect. In 2 outpatient visits to the Clinical Center, participants will have body fat analyses, an electrocardiogram, an oral glucose tolerance test, questionnaires about sleep and stress and an intravenous glucose tolerance test. This study has the potential to provide significant insight and lead to the development of programs that help decrease diabetes and cardiovascular risk in blacks.
|Study Type :||Observational|
|Estimated Enrollment :||1132 participants|
|Official Title:||Diabetes and Heart Disease Risk in Blacks|
|Actual Study Start Date :||October 21, 1998|
Healthy adult African Americans born in the United States, with American born parents or born in Africa with African born parents.
- Diabetes and Heart Disease Risk [ Time Frame: By Subject ]Glucose Tolerance Status Lipid Profile Sickle Cell Trait Status Glucose 6 Phosphate Dehydrogenase Activity
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001853
|Contact: Chis W Dubose||(301) email@example.com|
|Contact: Anne E Sumner, M.D.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||Anne E Sumner, M.D.||National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|