Diabetes and Heart Disease Risk in Blacks

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

About this trial

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 2000 healthy non-diabetic African American men and women (ages 18-70) 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 2 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

IINCLUSION AND

Disqualifiers

None

Trial population

Healthy volunteers of African descent,specifically African-born blacks and African Americans, recruited from the local area by flyer, newspaper advertisements, word of mouth and study personnel describing the study at community events.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

2,000 Participants
are grouped into 1 trial group
Group A: Healthy volunteers

Trial outcomes

Primary outcomes

1

Diabetes and Heart Disease Risk

Glucose Tolerance Status Lipid Profile Sickle Cell Trait Status Glucose 6 Phosphate Dehydrogenase Activity

Time frame
By Subject

Secondary outcomes

Other outcomes

Sponsors and contacts

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