💬In plain words
What the trial is, and whether it could suit you
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 corr
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
* IINCLUSION AND EXCLUSION CRITERIA
CRITERIA FOR INCLUSION:
Ethnicity: Black
This is a study of adult African Americans and Blacks that were born in Africa but are now living in the United States. As African American people are multi-ethnic, we will in this initial investigation, study two different groups of African American. 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 both groups we will study sex differences in the role of obesity and TG levels on cardiovascular disease. 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).
Only blacks are included in this study because the focus of this study is on gender differences in blacks in risk factors for CAD, specifically obesity, TG levels and TG related CAD risk factors. Unlike Caucasian women, premenopausal black women do not appear to be as protected from heart disease as a result of their gender. One model to study this apparent decrease in gender-related cardioprotection in black women is to compare black men to black women. An alternative model would be to compare black women to Caucasian women. However, since the primary focus of this work is on gender differences rather than racial differences comparing black women to men is a superior model. Other racial groups do not share the loss of gender-related cardioprotection found in blacks, and have been excluded. Further the advantage of comparing black men and women is that this comparison provides a better control of dietary, cultural and genetic factors.
Age: The age range of the participants will be between 18 and 70 years. As stated in the original protocol on page 14: "Future investigations are planned which will involve similar comparisons between premenopausal and postmenopausal black women and between whites and blacks." To investigate risk for glucose intolerance, diabetes and cardiovascular risk factors, it is no longer sufficient to maintain the age range between 18 and 50 years. We need to expand to an age range with an increased prevalence of these risk factors.
Medical History: To participate in the study subjects should identify themselves as healthy. This is important so the broadest possible sample of people will enroll. The fact that people are healthy will be confirmed by the history, physical and laboratory tests done as part of the screening visit. 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.
CRITERIA FOR EXCLUSION:
Black Ethnicity other than American or African.
As stated in the inclusion criteria black people are a multi-ethnic group. In this initial investigation we are focusing on African Americans who are American born and Africans living in the United States who are African born. In the future, we will expand the study to include other groups of blacks 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. People taking medications to treat hyperlipidemia will be included but analyses will be adjusted to take this into account. 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.
Pregnant or Breastfeeding: Women who are pregnant, breastfeeding, or have an infant that is less than four months of age will be excluded. This is because the physiologic changes associated with pregnancy, breastfeeding or recent childbirth affect the parameters under study.
Menstrual History: Now that postmenopausal women are included, menstrual history will be taken but women with irregular menses and hysterectomy will not be excluded. Women between the ages of 40 and 55 years will have FSH checked for proper characterization. Women 56 years of age and older will be assumed to be postmenopausal. However, women on any type of injectable hormonal contraception will be excluded because hormonal contraception affects both TG levels and glucose metabolism.
Note: All potential subjects that call for an appointment asking to be scheduled for a screening visit, will be asked on the phone if they meet the criteria for enrollment specifically before they come in it to be certain they would not be automatically excluded based on existing and defined "EXCLUSION CRITERIA". Therefore they will be asked if they have diabetes, what medications they take, if they have a history of a bleeding disorder and if they are female, if they are pregnant or breastfeeding?
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