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Sponsored by: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00484861 |
This study will examine the effect of the typical American diet on vascular disease risk in African-American and Caucasian women. Compared to other cultures, the American diet is high in fat. Fat in the typical American diet may explain why heart disease is the leading cause of death for American women.
Healthy pre-menopausal African-American and Caucasian women between 18 and 49 years of age who weigh less than 300 pounds may be eligible for this study.
Participants have 10 visits to the NIH Clinical Center to undergo the following procedures:
Visit 1
Medical history and physical exam, including questions about the subject's diet, exercise, family, education and employment.
Blood tests, urine tests and an electrocardiogram.
Visit 2
Brachial artery reactivity study: This test measures the rate at which blood flows through the brachial artery (a blood vessel in the arm). Ultrasound pictures of the arm are taken. Then a blood pressure cuff is placed on the arm and inflated for 5 minutes. After 5 minutes, the cuff is deflated and ultrasound pictures of the arm are taken again.
Glucose tolerance test: This test examines how well insulin is controlling the glucose (sugar) and fat in the blood. A catheter (plastic tube) is placed in a vein in each arm. The subject is given glucose through the catheter in one vein. After 20 minutes, a small amount of insulin is given through the same catheter. Blood samples are drawn through the catheter in the other arm at frequent intervals.
Visits 3-9
Dietary visits: Subjects come to the Clinical Center for 7 days to be weighed, eat breakfast and take home food for lunch, dinner, and snacks.
On one of these seven dietary visits, subjects have the following tests:
Visits 10
Test Meal: This visit is done to determine how a single meal affects fat levels and vascular function. Height, weight and blood pressure are measured.
Then, a catheter is placed in an arm vein and a blood sample is drawn. The brachial artery reactivity study is done as described for Visit 2. Then test meal consisting of a cheddar cheese omelet, orange juice and bagel with cream cheese is eaten. Blood is drawn and the brachial artery study is repeated at 2, 4 and 6 hours after the meal....
Condition |
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Cardiovascular Diseases Vascular Disease Inflammation Insulin Triglycerides |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | The Effect of Diet on Vascular Disease: A Study of Pre-Menopausal African American and Caucasian Women |
Estimated Enrollment: | 48 |
Study Start Date: | June 2007 |
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 48 women (24 African American and 24 Caucasian women). We are recruiting women because ethnic differences in triglyceride are even greater in women than men. To minimize the effect of age and menopause, we are enrolling women between the ages of 18 and 49 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.
Ages Eligible for Study: | 18 Years to 49 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
African American Women: Individuals will be considered to be African American if they self-identify as African American and were born in the United States. Further they must describe both parents as being African American and born in the United States.
Caucasian Women: Individuals will be considered to be Caucasian if they self-identify as Caucasian and were born in the United States. Further they must describe both parents as being Caucasian and born in the United States.
Healthy Volunteers: The potential enrollee must self identify as a normal volunteer and have this confirmed by having at the screening visit a normal complete blood count, glucose, BUN creatinine, liver and thyroid panel.
Age between 18 and 49 years: This age range is chosen because TG levels change at puberty and increase with age and postmenopausal status. However, we understand that vascular disease is not likely to be present in this age range. But our goal is not to detect vascular disease but to detect ethnic differences in the pathways that allow vascular disease to develop. Enrolling women between the ages of 18 and 49 years will minimize confounders and maximize our ability to detect differences in mechanism of action that are truly secondary to ethnicity rather than hormonal changes related to the life cycle.
Weight less than 136 kg (300 lbs): This weight restriction is necessitated by the limitations of the DXA scanner. The DXA platform cannot accommodate subjects who weigh more than 136 kg.
BMI between 20 and 45 kg/m(2): Women in both ethnic groups will be recruited across BMI nonobese and obese categories. Therefore we will enroll from each ethnic group 12 women with a BMI between 20 and 30 kg/m2 and 12 women with a BMI between 30 and 45 kg/m(2).
EXCLUSION CRITERIA:
Menopause: As the menopause can affect TG levels, menopausal women will be excluded. To ensure that menopausal women are excluded, FSH levels will be checked in women between the ages of 40 and 49 years. If the FSH level is elevated, the woman will be excluded.
Irregular menses: Women with irregular menses will be excluded. Irregular menses are a hallmark of the peri-menopause and polycystic ovarian disease (PCO). PCO adversely affects TG metabolism.
Refusal to agree to use barrier contraception: The DXA scan and CT scan should not be performed if the participant is pregnant. In addition, TG levels are directly affected by pregnancy. Even though we will perform pregnancy tests within 7 days of each visit, we also require that the subject agree to abstinence or barrier contraception throughout the study.
Medications which affect parameters under investigation: Examples include corticosteroids, oral contraceptives, hypoglycemic (oral or injection), hypolipidemic, antihypertensive and antipsychotic agents. Oral contraceptives, in particular, are exclusion criteria because the estrogen component of oral contraceptives increase TG levels and would therefore obscure the effect of the test meal on TG levels.
Medical Conditions which affect parameters under investigation: Examples include diabetes, thyroid disease, liver disease, pancreatitis, nephrotic syndrome.
Current Smokers: Smoking can affect TG levels, endothelial function and insulin resistance. Therefore current smokers will be excluded. Women who were past smokers but have not smoked for one year prior to enrollment will be allowed to participate.
Hispanics: The relationship between TG and insulin resistance in Hispanic White women is midway between African American and Caucasian women. Therefore in this initial study to be able to determine the maximum ethnic difference in the relationship between TG and insulin resistance, we will enroll in this protocol study women who self-identify as African American and Caucasian and not enroll women who self-identify as Hispanic.
Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
Contact: TTY | 1-866-411-1010 |
United States, Maryland | |
National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
Bethesda, Maryland, United States, 20892 |
Study ID Numbers: | 070163, 07-DK-0163 |
Study First Received: | June 8, 2007 |
Last Updated: | March 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00484861 History of Changes |
Health Authority: | United States: Federal Government |
Women Healthy Volunteers Triglyceride Healthy Volunteer HV |
Vascular Diseases Healthy Menopause Inflammation |
Pathologic Processes Vascular Diseases Cardiovascular Diseases Inflammation |