Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001853
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
1999-11-03
Brief Title:
Diabetes and Heart Disease Risk in Blacks
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Diabetes and Heart Disease Risk in Blacks
Status:
RECRUITING
Status Verified Date:
2024-08-13
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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
Detailed Description:
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 2000 healthy non-diabetic individuals age range 18- 70 and body mass index 3 subgroups nonobese overweight and obese In 2 outpatient visits to the Clinical Center participants will have body fat analyses an electrocardiogram an oral glucose tolerance test questionnaires about sleep stress discrimination resilience etc and an intravenous glucose tolerance test or a beverage 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
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 2000 healthy non-diabetic individuals age range 18- 70 and body mass index 3 subgroups nonobese overweight and obese In 2 outpatient visits to the Clinical Center participants will have body fat analyses an electrocardiogram an oral glucose tolerance test questionnaires about sleep stress discrimination resilience etc and an intravenous glucose tolerance test or a beverage 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 99-DK-0002 | None | None | None |