Cardiovascular DiseasesNCT00005388
Visceral Fat, Metabolic Rate, and CHD Risk in Young Adults
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To measure visceral (intraabdominal) fat by computerized tomography (CT) scan and to measure resting metabolic rate by indirect calorimetry in 400 CARDIA subjects, ages 28-40 years (100 of each race/gender group) from the Oakland, California and Birmingham, Alabama centers. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Coronary Disease
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 1995to Mar 2004
- 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 Up to 100 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
About this study
To measure visceral (intraabdominal) fat by computerized tomography (CT) scan and to measure resting metabolic rate by indirect calorimetry in 400 CARDIA subjects, ages 28-40 years (100 of each race/gender group) from the Oakland, California and Birmingham, Alabama centers.
Read the detailed description
BACKGROUND:
The prevalence of obesity increased markedly in the United States from the 1960's to the 1980's, and varied by race and gender with particularly high rates of obesity among Black women. Reasons for the ethnic differences in the prevalence of obesity were not understood. This cross-sectional study was performed in conjunction with the 10-year follow-up examination for the Coronary Artery Risk Development in Young Adults (CARDIA) study, an NHLBI-funded longitudinal study of development of risk factors for coronary heart disease (CHD) in young black and white adults.
This study represented a unique opportunity to investigate factors that may influence the development of obesity, to better understand the relationship between obesity and cardiovascular risk factors, and to increase understanding of racial differences in adiposity.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
DESIGN NARRATIVE:
The cross-sectional study tested the hypothesis that visceral adipose tissue, the component of fat considered to be most strongly related to coronary heart disease (CHD) risk factors, differed in Black and white subjects. Specifically, the investigators proposed that Black subjects had less visceral adipose tissue for a given level of total body fat than white subjects. Further, the relationship between visceral adipose tissue and risk factors for CHD was similar in all subjects. This would explain the different relationship between obesity and CHD risk factors seen in Black vs white subjects. A second specific aim was to determine whether Black women had a lower resting energy expenditure than Black men or whites. This could explain the higher prevalence of obesity in Black women than in Black men or whites of either gender. CT scans were recorded on tape and shipped to the University of Colorado Health Sciences Center where visceral adipose tissue was quantified. Dietary intake and physical activity were measured as important covariates in the relationship between metabolic rate and adiposity, and thyroid function was measured as a determinant of resting energy expenditure. The CARDIA study provided funding for cardiovascular risk factor measurements, including blood pressure, lipids, insulin, glucose, smoking, and anthropometric measurements including dual energy absorptiometry (DEXA) measurements of total and regional body fat.
The study was renewed in 1999 through March 2004 to perform a five-year follow-up of the cohort.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Coronary Disease, Obesity
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Coronary Disease, Obesity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startSep 1995
- Study completionMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 Heart, Lung, and Blood Institute (NHLBI)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
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Stephen Sidney, Kaiser Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005388
- Sponsor's protocol ID
- 4294
- Other IDs
- R01HL053359
- Status last verified
- Apr 2004
- First submitted
- 25 May 2000
- Last updated
- 18 Feb 2016
- Results posted
- No
Publications
Sidney S, Lewis CE, Hill JO, Quesenberry CP Jr, Stamm ER, Scherzinger A, Tolan K, Ettinger B. Association of total and central adiposity measures with fasting insulin in a biracial population of young adults with normal glucose tolerance: the CARDIA study. Obes Res. 1999 May;7(3):265-72. doi: 10.1002/j.1550-8528.1999.tb00405.x.
PubMed 10348497Hill JO, Sidney S, Lewis CE, Tolan K, Scherzinger AL, Stamm ER. Racial differences in amounts of visceral adipose tissue in young adults: the CARDIA (Coronary Artery Risk Development in Young Adults) study. Am J Clin Nutr. 1999 Mar;69(3):381-7. doi: 10.1093/ajcn/69.3.381.
PubMed 10075320Sharp TA, Bell ML, Grunwald GK, Schmitz KH, Sidney S, Lewis CE, Tolan K, Hill JO. Differences in resting metabolic rate between white and African-American young adults. Obes Res. 2002 Aug;10(8):726-32. doi: 10.1038/oby.2002.99.
PubMed 12181380Simon JA, Murtaugh MA, Gross MD, Loria CM, Hulley SB, Jacobs DR Jr. Relation of ascorbic acid to coronary artery calcium: the Coronary Artery Risk Development in Young Adults Study. Am J Epidemiol. 2004 Mar 15;159(6):581-8. doi: 10.1093/aje/kwh079.
PubMed 15003962
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visceral Fat, Metabolic Rate, and CHD Risk in Young Adults
- ClinicalTrials.gov ID
- NCT00005388
- Acronym / sponsor ID
- 4294
- Conditions
- Cardiovascular Diseases, Heart Diseases, Coronary Disease, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Sep 1995
- Study completion
- Mar 2004 (actual)
- First posted
- 26 May 2000 (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.
To measure visceral (intraabdominal) fat by computerized tomography (CT) scan and to measure resting metabolic rate by indirect calorimetry in 400 CARDIA subjects, ages 28-40 years (100 of each race/gender group) from the Oakland, California and Birmingham, Alabama centers.
Detailed description
BACKGROUND:
The prevalence of obesity increased markedly in the United States from the 1960's to the 1980's, and varied by race and gender with particularly high rates of obesity among Black women. Reasons for the ethnic differences in the prevalence of obesity were not understood. This cross-sectional study was performed in conjunction with the 10-year follow-up examination for the Coronary Artery Risk Development in Young Adults (CARDIA) study, an NHLBI-funded longitudinal study of development of risk factors for coronary heart disease (CHD) in young black and white adults.
This study represented a unique opportunity to investigate factors that may influence the development of obesity, to better understand the relationship between obesity and cardiovascular risk factors, and to increase understanding of racial differences in adiposity.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
DESIGN NARRATIVE:
The cross-sectional study tested the hypothesis that visceral adipose tissue, the component of fat considered to be most strongly related to coronary heart disease (CHD) risk factors, differed in Black and white subjects. Specifically, the investigators proposed that Black subjects had less visceral adipose tissue for a given level of total body fat than white subjects. Further, the relationship between visceral adipose tissue and risk factors for CHD was similar in all subjects. This would explain the different relationship between obesity and CHD risk factors seen in Black vs white subjects. A second specific aim was to determine whether Black women had a lower resting energy expenditure than Black men or whites. This could explain the higher prevalence of obesity in Black women than in Black men or whites of either gender. CT scans were recorded on tape and shipped to the University of Colorado Health Sciences Center where visceral adipose tissue was quantified. Dietary intake and physical activity were measured as important covariates in the relationship between metabolic rate and adiposity, and thyroid function was measured as a determinant of resting energy expenditure. The CARDIA study provided funding for cardiovascular risk factor measurements, including blood pressure, lipids, insulin, glucose, smoking, and anthropometric measurements including dual energy absorptiometry (DEXA) measurements of total and regional body fat.
The study was renewed in 1999 through March 2004 to perform a five-year follow-up of the cohort.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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
Not reported in the source record.
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 18 Feb 2016.
- Background: PubMed 10348497Sidney S, Lewis CE, Hill JO, Quesenberry CP Jr, Stamm ER, Scherzinger A, Tolan K, Ettinger B. Association of total and central adiposity measures with fasting insulin in a biracial population of young adults with normal glucose tolerance: the CARDIA study. Obes Res. 1999 May;7(3):265-72. doi: 10.1002/j.1550-8528.1999.tb00405.x.
- Background: PubMed 10075320Hill JO, Sidney S, Lewis CE, Tolan K, Scherzinger AL, Stamm ER. Racial differences in amounts of visceral adipose tissue in young adults: the CARDIA (Coronary Artery Risk Development in Young Adults) study. Am J Clin Nutr. 1999 Mar;69(3):381-7. doi: 10.1093/ajcn/69.3.381.
- Background: PubMed 12181380Sharp TA, Bell ML, Grunwald GK, Schmitz KH, Sidney S, Lewis CE, Tolan K, Hill JO. Differences in resting metabolic rate between white and African-American young adults. Obes Res. 2002 Aug;10(8):726-32. doi: 10.1038/oby.2002.99.
- Background: PubMed 15003962Simon JA, Murtaugh MA, Gross MD, Loria CM, Hulley SB, Jacobs DR Jr. Relation of ascorbic acid to coronary artery calcium: the Coronary Artery Risk Development in Young Adults Study. Am J Epidemiol. 2004 Mar 15;159(6):581-8. doi: 10.1093/aje/kwh079.
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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.
Stephen Sidney
Kaiser Foundation
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 18 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005388, which also lists 4 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 18 Feb 2016.