Diabetes and Heart Disease Risk in Blacks

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 3 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.

- INCLUSION CRITERIA:

Ethnicity: African Americans

To enroll participants must self-identify as African Americans and be born in the United
States, with American born parents or be born in Africa with African born parents. In the
future, we plan to expand the study to include other groups which self-identify as African
Americans (i.e. AfroCarribeans and Hispanic blacks).

Age: The age range of the participants will be between 18 and 50 years.

Medical History: To participate in the study subjects should identify themselves as
healthy.

Menstrual History: Women must give a history of regular monthly cycles (24-35 days) for at
least one year.

EXCLUSION CRITERIA:

African American Ethnicity other than American or West African ancestry. In the future, we
will expand the study to include other African American groups such as individuals of
Afro-Caribbean and Hispanic blacks.

Medications: People who take medications that are known to alter the parameters which are
under investigation in this study will be excluded. An example would be medications used to
treat hyperlipidemia such as statins, niacin, bile acid sequestrants and fibric acid
derivatives. Subjects on thyroid hormone replacement will be included if their TSH is
normal.

Diabetes: Because diabetes affects insulin sensitivity and TG levels all people with
diabetes even if the diabetes is controlled with diet alone will not be enrolled in the
study.

Breastfeeding: Women who are breastfeeding or have an infant that is less than four months
of age will be excluded. This is because the physiologic changes associated with
breastfeeding or recent childbirth affect the parameters under study.

Menstrual History: Women with a history of irregular menstrual cycles in the year prior to
the study will be excluded. Due to the requirement for regular menses, 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