Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00074945
Status:
COMPLETED
Last Update Posted:
2017-10-06
First Post:
2003-12-23
Brief Title:
Obesity and Fatty Acid Flux Comparison Trials
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Comparison of Free Fatty Acid Flux in African Americans and Caucasians
Status:
COMPLETED
Status Verified Date:
2013-02-28
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:
This study will explore factors that affect obesity and obesity-related diseases in both Caucasians and African Americans By looking at the rate at which the human body burns calories while at rest resting energy expenditure or REE and at the rate at which fat travels through the blood fatty acid flux this study will examine the relationship between REE and fatty acid flux both of which are determinants of obesity Researchers will compare the test results of Caucasians and African Americans to determine if race has an effect on the relationship between REE and fatty acid flux
Volunteers must be between 18 and 49 years of age Equal numbers of typical weight overweight and obese participants will be recruited Candidates will be screened with a physical examination electrocardiogram and blood tests and will be interviewed about diet and exercise habits family and medical history and employment
Participants will be placed on a two-week maintenance diet prepared by a dietician to regulate and maintain calorie consumption and must visit an outpatient clinic for weight measurement for 10 consecutive weekdays During the two-week diet participants will also undergo two 20-minute computerized scans to measure abdominal and body fat At the end of the two weeks participants will then be hospitalized for two days to allow researchers to conduct blood tests oral glucose tests and a physical examination to measure REE and fatty acid flux levels for comparison
Volunteers must be between 18 and 49 years of age Equal numbers of typical weight overweight and obese participants will be recruited Candidates will be screened with a physical examination electrocardiogram and blood tests and will be interviewed about diet and exercise habits family and medical history and employment
Participants will be placed on a two-week maintenance diet prepared by a dietician to regulate and maintain calorie consumption and must visit an outpatient clinic for weight measurement for 10 consecutive weekdays During the two-week diet participants will also undergo two 20-minute computerized scans to measure abdominal and body fat At the end of the two weeks participants will then be hospitalized for two days to allow researchers to conduct blood tests oral glucose tests and a physical examination to measure REE and fatty acid flux levels for comparison
Detailed Description:
Thirty percent of Americans are obese Women are more severely affected than men African-Americans are more severely affected than Caucasians
To understand the metabolic consequences of obesity it is essential to know the rate at which free fatty acids FFA are released from adipose tissue Circulating FFA contribute to the complications of obesity particularly diabetes and heart disease As there are sex and race differences in the prevalence of all these conditions there may be sex and race differences in FFA flux FFA flux represents the rate at which FFA circulate FFA flux is the result of three processes going on at the same time 1 the rate FFA are released from adipose tissue 2 the rate circulating FFA are used for energy and 3 the rate FFA leaves the circulation to re-enter adipose tissue No data is available on whether sex and race differences in FFA flux exist Further when comparing subjects of different size sex and race it is unknown whether FFA flux should be corrected for lean body mass or resting energy expenditure
To determine if there are sex and race differences in FFA flux and to ensure adequate enrollment of both African American and Caucasians this investigation is a collaborative effort between the National Institutes of Health NIH in Bethesda Maryland and the Mayo Clinic in Olmsted County Minnesota The greater Washington DC metropolitan area where NIH is located has a large African-American community whereas over 90 percent of residents of Olmsted County are Caucasians Therefore sex differences in FFA flux in African Americans will be mainly studied at the National Institutes of Health Sex differences in FFA flux in Caucasians will be mainly studied at the Mayo Clinic But to confirm the ability to combine data from two different sites some Caucasians will be enrolled at NIH and some African Americans will be enrolled at the Mayo Clinic The results of the two studies will be combined to determine if there are race differences in FFA flux
At NIH 50 African-Americans 25M 25W age range 18-49 years and 14 Caucasians 7M 7W age range 18-49 years will be enrolled Equal numbers of normal weight overweight and obese subjects will be recruited As outpatients participants will be placed on weight maintaining diets for two weeks and then admitted for a two-day hospital stay On each in-hospital morning resting energy expenditure will be measured and stable isotopes infused to measure FFA flux Stable isotopes are naturally occurring forms of elements which are safe and non-radioactive
From the study of African-Americans at NIH it will be possible to determine if a the rate of FFA release in African-Americans is more highly related to lean body mass or to resting energy expenditure and b if there is a sex difference in this relationship Then as described above the results from the Mayo Clinic and NIH will be combined to determine if there are race differences in the FFA flux
To understand the metabolic consequences of obesity it is essential to know the rate at which free fatty acids FFA are released from adipose tissue Circulating FFA contribute to the complications of obesity particularly diabetes and heart disease As there are sex and race differences in the prevalence of all these conditions there may be sex and race differences in FFA flux FFA flux represents the rate at which FFA circulate FFA flux is the result of three processes going on at the same time 1 the rate FFA are released from adipose tissue 2 the rate circulating FFA are used for energy and 3 the rate FFA leaves the circulation to re-enter adipose tissue No data is available on whether sex and race differences in FFA flux exist Further when comparing subjects of different size sex and race it is unknown whether FFA flux should be corrected for lean body mass or resting energy expenditure
To determine if there are sex and race differences in FFA flux and to ensure adequate enrollment of both African American and Caucasians this investigation is a collaborative effort between the National Institutes of Health NIH in Bethesda Maryland and the Mayo Clinic in Olmsted County Minnesota The greater Washington DC metropolitan area where NIH is located has a large African-American community whereas over 90 percent of residents of Olmsted County are Caucasians Therefore sex differences in FFA flux in African Americans will be mainly studied at the National Institutes of Health Sex differences in FFA flux in Caucasians will be mainly studied at the Mayo Clinic But to confirm the ability to combine data from two different sites some Caucasians will be enrolled at NIH and some African Americans will be enrolled at the Mayo Clinic The results of the two studies will be combined to determine if there are race differences in FFA flux
At NIH 50 African-Americans 25M 25W age range 18-49 years and 14 Caucasians 7M 7W age range 18-49 years will be enrolled Equal numbers of normal weight overweight and obese subjects will be recruited As outpatients participants will be placed on weight maintaining diets for two weeks and then admitted for a two-day hospital stay On each in-hospital morning resting energy expenditure will be measured and stable isotopes infused to measure FFA flux Stable isotopes are naturally occurring forms of elements which are safe and non-radioactive
From the study of African-Americans at NIH it will be possible to determine if a the rate of FFA release in African-Americans is more highly related to lean body mass or to resting energy expenditure and b if there is a sex difference in this relationship Then as described above the results from the Mayo Clinic and NIH will be combined to determine if there are race differences in the FFA flux
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 |
|---|---|---|---|
| 04-DK-0061 | None | None | None |