Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00484861
Status:
COMPLETED
Last Update Posted:
2019-12-17
First Post:
2007-06-08
Brief Title:
Effect of Diet on Vascular Disease in Pre-Menopausal Women
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
The Effect of Diet on Vascular Disease A Study of African American and Caucasian Women
Status:
COMPLETED
Status Verified Date:
2017-02-14
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:
African Americans have a higher prevalence of vascular disease than Caucasians Vascular disease can lead to heart attacks strokes and even amputations Insulin a hormone which is secreted by the pancreas affects not only glucose and fat metabolism but also vascular disease Impairment of insulin s ability to remove glucose from the circulation is known as insulin resistance To overcome insulin resistance the pancreas secretes extra insulin These high levels of insulin affect circulating triglyceride levels by both promoting production of triglyceride by the liver and interfering with clearance of triglyceride from the circulation Triglyceride in turn contributes to the development of vascular disease by causing both inflammation and hypercoagulability
Surprisingly African Americans are more insulin resistant and have a higher rate of vascular disease than Caucasians but have lower triglyceride levels Because of the high rate of vascular diseases in African Americans our aim is to determine if the adverse effects of triglyceride occur at a lower level in African Americans than Caucasians To achieve this goal we will determine if there are differences in the effect of a meal on triglyceride levels and vascular function in a representative cohort of African American and Caucasian women
For this study we will enroll 96 women 48 African American and 48 Caucasian women We are recruiting women because ethnic differences in triglyceride are even greater in women than men We are enrolling women between the ages of 18 and 65 years The study will involve several outpatient visits to the NIH Clinical Center The first visit will be a screening to determine eligibility At the second visit a test to measure insulin resistance will be performed This test is called a frequently sampled intravenous glucose tolerance test The third visit will be for the test meal Before and at 2 4 and 6 hours after the meal blood will be drawn and vascular function measured Vascular function is determined by taking blood pressure and then measuring blood flow in the arm with ultrasound It is possible that individual differences in diet could affect the results of the vascular study on the day of the test meal Therefore for 7 days prior to the test meal the NIH Clinical Center will provide to each participant all their meals in the form of either trays or meals in a box These meals will be consistent with the typical American diet and be 33 fat 15 protein and 52 carbohydrate In designing these meals the dietician will take into account individual food preferences
This study is being performed in collaboration with the Harvard School of Public Health the University of Texas Southwestern Medical Center and Indiana University Therefore some blood drawn during Visits 2 and 3 will be sent coded without personal identifiers to each institution for analyses
Surprisingly African Americans are more insulin resistant and have a higher rate of vascular disease than Caucasians but have lower triglyceride levels Because of the high rate of vascular diseases in African Americans our aim is to determine if the adverse effects of triglyceride occur at a lower level in African Americans than Caucasians To achieve this goal we will determine if there are differences in the effect of a meal on triglyceride levels and vascular function in a representative cohort of African American and Caucasian women
For this study we will enroll 96 women 48 African American and 48 Caucasian women We are recruiting women because ethnic differences in triglyceride are even greater in women than men We are enrolling women between the ages of 18 and 65 years The study will involve several outpatient visits to the NIH Clinical Center The first visit will be a screening to determine eligibility At the second visit a test to measure insulin resistance will be performed This test is called a frequently sampled intravenous glucose tolerance test The third visit will be for the test meal Before and at 2 4 and 6 hours after the meal blood will be drawn and vascular function measured Vascular function is determined by taking blood pressure and then measuring blood flow in the arm with ultrasound It is possible that individual differences in diet could affect the results of the vascular study on the day of the test meal Therefore for 7 days prior to the test meal the NIH Clinical Center will provide to each participant all their meals in the form of either trays or meals in a box These meals will be consistent with the typical American diet and be 33 fat 15 protein and 52 carbohydrate In designing these meals the dietician will take into account individual food preferences
This study is being performed in collaboration with the Harvard School of Public Health the University of Texas Southwestern Medical Center and Indiana University Therefore some blood drawn during Visits 2 and 3 will be sent coded without personal identifiers to each institution for analyses
Detailed Description:
African Americans have a higher prevalence of vascular disease than Caucasians Vascular disease can lead to heart attacks strokes and even amputations Insulin a hormone which is secreted by the pancreas affects not only glucose and fat metabolism but also vascular disease Impairment of insulin s ability to remove glucose from the circulation is known as insulin resistance To overcome insulin resistance the pancreas secretes extra insulin These high levels of insulin affect circulating triglyceride levels by both promoting production of triglyceride by the liver and interfering with clearance of triglyceride from the circulation Triglyceride in turn contributes to the development of vascular disease by causing both inflammation and hypercoagulability
Surprisingly African Americans are more insulin resistant and have a higher rate of vascular disease than Caucasians but have lower triglyceride levels Because of the high rate of vascular diseases in African Americans our aim is to determine if the adverse effects of triglyceride occur at a lower level in African Americans than Caucasians To achieve this goal we will determine if there are differences in the effect of a meal on triglyceride levels and vascular function in a representative cohort of African American and Caucasian women
For this study we will enroll 96 women 48 African American and 48 Caucasian women We are recruiting women because ethnic differences in triglyceride are even greater in women than men We are enrolling women between the ages of 18 and 65 years The study will involve several outpatient visits to the NIH Clinical Center The first visit will be a screening to determine eligibility At the second visit a test to measure insulin resistance will be performed This test is called a frequently sampled intravenous glucose tolerance test The third visit will be for the test meal Before and at 2 4 and 6 hours after the meal blood will be drawn and vascular function measured Vascular function is determined by taking blood pressure and then measuring blood flow in the arm with ultrasound It is possible that individual differences in diet could affect the results of the vascular study on the day of the test meal Therefore for 7 days prior to the test meal the NIH Clinical Center will provide to each participant all their meals in the form of either trays or meals in a box These meals will be consistent with the typical American diet and be 33 fat 15 protein and 52 carbohydrate In designing these meals the dietician will take into account individual food preferences
This study is being performed in collaboration with the Harvard School of Public Health the University of Texas Southwestern Medical Center and Indiana University Therefore some blood drawn during Visits 2 and 3 will be sent coded without personal identifiers to each institution for analyses
Surprisingly African Americans are more insulin resistant and have a higher rate of vascular disease than Caucasians but have lower triglyceride levels Because of the high rate of vascular diseases in African Americans our aim is to determine if the adverse effects of triglyceride occur at a lower level in African Americans than Caucasians To achieve this goal we will determine if there are differences in the effect of a meal on triglyceride levels and vascular function in a representative cohort of African American and Caucasian women
For this study we will enroll 96 women 48 African American and 48 Caucasian women We are recruiting women because ethnic differences in triglyceride are even greater in women than men We are enrolling women between the ages of 18 and 65 years The study will involve several outpatient visits to the NIH Clinical Center The first visit will be a screening to determine eligibility At the second visit a test to measure insulin resistance will be performed This test is called a frequently sampled intravenous glucose tolerance test The third visit will be for the test meal Before and at 2 4 and 6 hours after the meal blood will be drawn and vascular function measured Vascular function is determined by taking blood pressure and then measuring blood flow in the arm with ultrasound It is possible that individual differences in diet could affect the results of the vascular study on the day of the test meal Therefore for 7 days prior to the test meal the NIH Clinical Center will provide to each participant all their meals in the form of either trays or meals in a box These meals will be consistent with the typical American diet and be 33 fat 15 protein and 52 carbohydrate In designing these meals the dietician will take into account individual food preferences
This study is being performed in collaboration with the Harvard School of Public Health the University of Texas Southwestern Medical Center and Indiana University Therefore some blood drawn during Visits 2 and 3 will be sent coded without personal identifiers to each institution for analyses
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| 07-DK-0163 | None | None | None |