Protocol Number: 99-DK-0002

Title:

Heart Disease Risk Factors in African Americans

Number:

99-DK-0002

Summary:

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.

Sponsoring Institute:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): American Indian or Alaskan Native

Asian/Pacific Islander

White (Not of Hispanic Origin)

Hispanic

Eligibility 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 takimg oral contraceptives will not be enrolled.

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.

Special Instructions: Currently Not Provided

Keywords:

Triglyceride

Insulin Resistance

Lipoprotein Lipase

Obesity

Visceral Fat

Recruitment Keywords:

None

Conditions:

Coronary Disease

Obesity

Investigational Drug(s):

None

Investigational Device(s):

None

Contacts:

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:

Obesity as an independent risk factor for cardiovascular disease: a 26-year follow-up of participants in the Framingham heart study

Body mass index and body girths as predictors of mortality in black and white women

The body mass index-mortality relationship in white and African American women

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
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