NCT00484861

Effect of Diet on Vascular Disease in Pre-Menopausal Women

Completed Last updated 17 December 2019

What this trial tests

trial in Cardiovascular Diseases in 47 participants. Completed in 14 February 2017.

Timeline

7 June 2007

14 February 2017

Quick facts

Lead sponsor	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	47
Start date	7 June 2007
Estimated completion	14 February 2017
Sites	1 location across United States

Conditions studied

• Cardiovascular Diseases — all drugs for Cardiovascular Diseases →
• Vascular Disease — all drugs for Vascular Disease →
• Inflammation — all drugs for Inflammation →
• Insulin — all drugs for Insulin →

Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Who can join

Adults 18 to 65, female only, with Cardiovascular Diseases or Vascular Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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.

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Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Worse cardiometabolic health in African immigrant men than African American men: reconsideration of the healthy immigrant effect.
   O'Connor MY, Thoreson CK, Ricks M, Courville AB, et al · · 2014 · cited 59× · PMID 24814168 · DOI 10.1089/met.2014.0026
2. Detection of abnormal glucose tolerance in Africans is improved by combining A1C with fasting glucose: the Africans in America Study.
   Sumner AE, Thoreson CK, O'Connor MY, Ricks M, et al · · 2015 · cited 39× · PMID 25338926 · DOI 10.2337/dc14-1179
3. ApoC-III and visceral adipose tissue contribute to paradoxically normal triglyceride levels in insulin-resistant African-American women.
   Sumner AE, Furtado JD, Courville AB, Ricks M, et al · · 2013 · cited 10× · PMID 24365086 · DOI 10.1186/1743-7075-10-73
4. Racial differences between African-American and white women in insulin resistance and visceral adiposity are associated with differences in apoCIII containing apoAI and apoB lipoproteins.
   Wang L, Sacks FM, Furtado JD, Ricks M, et al · · 2014 · cited 7× · PMID 25553059 · DOI 10.1186/1743-7075-11-56
5. Biochemical and clinical deficiency is uncommon in African immigrants despite a high prevalence of low vitamin D: the Africans in America study.
   Thoreson CK, Chung ST, Ricks M, Reynolds JC, et al · · 2015 · cited 6× · PMID 26001560 · DOI 10.1007/s00198-015-3169-z