Cardiovascular DiseasesNCT00484861
Effect of Diet on Vascular Disease in Pre-Menopausal Women
An observational study of Cardiovascular Diseases and Vascular Disease, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Vascular Disease, Inflammation
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2007to 14 Feb 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- Caucasian Women: Individuals will be considered to be Caucasian if they self-identify as Caucasian.
- 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 65 years: This age range is chosen because TG levels across the lifespan from early adulthood through to postmenopausal status. Weare using 65 years of age as a conventional upper limit. In addition, 65 years of age has been used as an age category cut-off by National Health and Nutrition Examination Surveys. Our goal is to detect ethnic differences in the pathways that allow vascular disease to develop. Enrolling women between the ages of 18 and 65 years, maximizes our ability to detect differences in mechanism of action that are truly secondary to ethnicity.
- 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/m2: Women in both ethnic groups will be recruited across BMI nonobese and obese categories. Therefore we will enroll approximately equal numbers of women from each ethnic group in both BMI categories BMI between 20 and 30 kg/m(2) and BMI between 30 and 45 kg/m(2).
Who cannot join
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
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.
Read more
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.
...
Read the 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.
- Conditions
- Cardiovascular Diseases, Vascular Disease, Inflammation, Insulin, Triglycerides
- Keywords
- Women, Healthy Volunteers, Triglyceride, Healthy Volunteer, HV
- Medical subject headings
- Cardiovascular Diseases, Vascular Diseases, Inflammation, Insulin Resistance
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in endothelial function after a meal.
Secondary outcomes (1)
Ability of the presence or absence of insulin resistance to predict change in endothelial function after a meal.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2007 (estimated)
- Study start7 Jun 2007
- Study completion14 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Anne E Sumner, M.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00484861
- Sponsor's protocol ID
- 070163
- Other IDs
- 07-DK-0163
- Status last verified
- 14 Feb 2017
- First submitted
- 8 Jun 2007
- Last updated
- 17 Dec 2019
- Results posted
- No
Publications
Ferdinand KC. Coronary artery disease in minority racial and ethnic groups in the United States. Am J Cardiol. 2006 Jan 16;97(2A):12A-19A. doi: 10.1016/j.amjcard.2005.11.011. Epub 2005 Dec 1.
PubMed 16442932Schwartz EA, Reaven PD. Molecular and signaling mechanisms of atherosclerosis in insulin resistance. Endocrinol Metab Clin North Am. 2006 Sep;35(3):525-49, viii. doi: 10.1016/j.ecl.2006.06.005.
PubMed 16959584Kissebah AH, Alfarsi S, Adams PW, Wynn V. Role of insulin resistance in adipose tissue and liver in the pathogenesis of endogenous hypertriglyceridaemia in man. Diabetologia. 1976 Dec;12(6):563-71. doi: 10.1007/BF01220632.
PubMed 187517Wang L, Sacks FM, Furtado JD, Ricks M, Courville AB, Sumner AE. 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. Nutr Metab (Lond). 2014 Dec 17;11(1):56. doi: 10.1186/1743-7075-11-56. eCollection 2014.
PubMed 25553059Sumner AE, Thoreson CK, O'Connor MY, Ricks M, Chung ST, Tulloch-Reid MK, Lozier JN, Sacks DB. Detection of abnormal glucose tolerance in Africans is improved by combining A1C with fasting glucose: the Africans in America Study. Diabetes Care. 2015 Feb;38(2):213-9. doi: 10.2337/dc14-1179. Epub 2014 Oct 22.
PubMed 25338926Sumner AE, Furtado JD, Courville AB, Ricks M, Younger-Coleman N, Tulloch-Reid MK, Sacks FM. ApoC-III and visceral adipose tissue contribute to paradoxically normal triglyceride levels in insulin-resistant African-American women. Nutr Metab (Lond). 2013 Dec 23;10(1):73. doi: 10.1186/1743-7075-10-73.
PubMed 24365086
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Diet on Vascular Disease: A Study of African American and Caucasian Women
- ClinicalTrials.gov ID
- NCT00484861
- Acronym / sponsor ID
- 070163
- Conditions
- Cardiovascular Diseases, Vascular Disease, Inflammation, Insulin, Triglycerides
- Keywords
- Women, Healthy Volunteers, Triglyceride, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 7 Jun 2007
- Study completion
- 14 Feb 2017
- First posted
- 11 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
...
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- Caucasian Women: Individuals will be considered to be Caucasian if they self-identify as Caucasian.
- 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 65 years: This age range is chosen because TG levels across the lifespan from early adulthood through to postmenopausal status. Weare using 65 years of age as a conventional upper limit. In addition, 65 years of age has been used as an age category cut-off by National Health and Nutrition Examination Surveys. Our goal is to detect ethnic differences in the pathways that allow vascular disease to develop. Enrolling women between the ages of 18 and 65 years, maximizes our ability to detect differences in mechanism of action that are truly secondary to ethnicity.
- 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.
Key exclusion criteria (4 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in endothelial function after a meal.
1 secondary outcome
Ability of the presence or absence of insulin resistance to predict change in endothelial function after a meal.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
- Background: PubMed 16442932Ferdinand KC. Coronary artery disease in minority racial and ethnic groups in the United States. Am J Cardiol. 2006 Jan 16;97(2A):12A-19A. doi: 10.1016/j.amjcard.2005.11.011. Epub 2005 Dec 1.
- Background: PubMed 16959584Schwartz EA, Reaven PD. Molecular and signaling mechanisms of atherosclerosis in insulin resistance. Endocrinol Metab Clin North Am. 2006 Sep;35(3):525-49, viii. doi: 10.1016/j.ecl.2006.06.005.
- Background: PubMed 187517Kissebah AH, Alfarsi S, Adams PW, Wynn V. Role of insulin resistance in adipose tissue and liver in the pathogenesis of endogenous hypertriglyceridaemia in man. Diabetologia. 1976 Dec;12(6):563-71. doi: 10.1007/BF01220632.
- Derived from this study: PubMed 25553059Wang L, Sacks FM, Furtado JD, Ricks M, Courville AB, Sumner AE. 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. Nutr Metab (Lond). 2014 Dec 17;11(1):56. doi: 10.1186/1743-7075-11-56. eCollection 2014.
- Derived from this study: PubMed 25338926Sumner AE, Thoreson CK, O'Connor MY, Ricks M, Chung ST, Tulloch-Reid MK, Lozier JN, Sacks DB. Detection of abnormal glucose tolerance in Africans is improved by combining A1C with fasting glucose: the Africans in America Study. Diabetes Care. 2015 Feb;38(2):213-9. doi: 10.2337/dc14-1179. Epub 2014 Oct 22.
- Derived from this study: PubMed 24365086Sumner AE, Furtado JD, Courville AB, Ricks M, Younger-Coleman N, Tulloch-Reid MK, Sacks FM. ApoC-III and visceral adipose tissue contribute to paradoxically normal triglyceride levels in insulin-resistant African-American women. Nutr Metab (Lond). 2013 Dec 23;10(1):73. doi: 10.1186/1743-7075-10-73.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne E Sumner, M.D. principal investigator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Vascular Disease, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in endothelial function after a meal.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00484861, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2019.