Cardiovascular Diseases Clinical Trial
Official title:
The Effect of Diet on Vascular Disease: A Study of African American and Caucasian Women
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.
...
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.
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