| Conditions: |
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Coronary Disease - Obesity |
| Purpose: |
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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.
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| Study Summary: |
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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 [1]. 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 [2]. In fact, black women independent of body weight or
triglyceride levels experience high mortality from coronary artery disease [3]. Our earlier
research has demonstrated that obese black men have elevated triglyceride levels but obese
black women have normal triglyceride levels [4]. 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.
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| Criteria: |
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- 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
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| NCT ID: |
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NCT00001853 |
| Primary Contact: |
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Principal Investigator
Anne E Sumner, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Anne E Sumner, M.D.
Phone: (301) 402-7119
Email: annes@intra.niddk.nih.gov
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| Backup Contact: |
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N/A |
| Location Contact: |
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Bethesda, Maryland 20892
United States
For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)
Phone: 800-411-1222
Email: prpl@mail.cc.nih.gov
Site Status: Recruiting |