Heart DiseasesNCT00005248
Adiposity and Fat Patterning in Black Americans
An observational study of Heart Diseases and Diabetes Mellitus, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To examine the relationships of obesity and fat patterning with morbidity and mortality in Black Americans. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Heart Diseases, Diabetes Mellitus, Obesity
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Aug 1989to Jul 1992
- 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
No eligibility criteria
About this study
To examine the relationships of obesity and fat patterning with morbidity and mortality in Black Americans.
Read the detailed description
BACKGROUND:
Studies have shown that fat patterning is an important risk factor for diabetes and possibly cardiovascular diseases. The Secretary's Task Force on Black and Minority Health in 1985 concluded that diabetes and cardiovascular diseases were among the six causes of death that contribute most to the disparity in death rates between Blacks and whites, yet the relationship of fat patterning with these diseases was largely unstudied in Blacks. Since there are known racial differences in growth rates, body proportions, and adiposity, it cannot be assumed that studies done on whites are applicable to Blacks.
The Charleston Heart Study began in 1960 with the examination of a random sample of 2181 residents of Charleston County. Approximately one-third of the sample was Black. The cohort was re-examined in 1963-1964, 1974-1975, and 1984-1985, and the fifth recall involving physical examination, electrocardiogram, echocardiograph, plasma glucose and lipid assays, physical disability assessment, and 24-hour Holter monitoring was completed. In the 1963-1964 recall, 102 high socioeconomic status Black men were added to the cohort. Also, in the 1963-1964 recall a battery of anthropometric measurements were taken on about half the cohort and these measurements and others were included in the 1987-1988 recall. Thus height, weight, reported weight at age 25, circumference of the chest at inhale and exhale, circumference at the umbilicus and mid-arm circumference were available on the same individuals from the 1963-1964 and the 1987-1988 examinations. In addition, skinfolds at the triceps, biceps, subscapular, suprailiac and lower thigh and circumference at the hips were measured in the latter recall. The fifth examination was completed in 1989 under separate NHLBI grant support.
DESIGN NARRATIVE:
Cross-sectional relationships were estimated between anthropometric measures of body dimensions such as abdominal, central and upper body fat patterning, and total adiposity and the dependent variables of diabetes, blood pressure, plasma lipids and glucose, and left ventricular wall thickness. Anthropometric predictors of diabetes, blood pressure, plasma lipids and glucose, and left ventricular wall thickness were identified over a 24 year interval. Anthropometric predictors of survival were identified over a 25 year period with reference to mortality for coronary heart disease, cardiovascular disease, and all-cause mortality. Body dimensions were described by race and sex groups and changes in the shapes of individuals over a 24 year interval were examined. The importance of changes in anthropometric measurements with aging was determined for the prediction of diabetes, blood pressure, plasma lipids and glucose, left ventricular wall thickness, mortality from all causes and from coronary heart disease and cardiovascular disease.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
- Conditions
- Heart Diseases, Diabetes Mellitus, Obesity
- Medical subject headings
- Heart Diseases, Diabetes Mellitus, 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 startAug 1989
- Study completionJul 1992
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005248
- Sponsor's protocol ID
- 1130
- Other IDs
- 5R01HL042305
- Status last verified
- May 2002
- First submitted
- 25 May 2000
- Last updated
- 18 Feb 2016
- Results posted
- No
Publications
Stevens J, Gautman SP, Keil JE. Body mass index and fat patterning as correlates of lipids and hypertension in an elderly, biracial population. J Gerontol. 1993 Nov;48(6):M249-54. doi: 10.1093/geronj/48.6.m249.
PubMed 8227994Stevens J, Keil JE, Waid LR, Gazes PC. Accuracy of current, 4-year, and 28-year self-reported body weight in an elderly population. Am J Epidemiol. 1990 Dec;132(6):1156-63. doi: 10.1093/oxfordjournals.aje.a115758.
PubMed 2260547
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
- Adiposity and Fat Patterning in Black Americans
- ClinicalTrials.gov ID
- NCT00005248
- Acronym / sponsor ID
- 1130
- Conditions
- Heart Diseases, Diabetes Mellitus, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Aug 1989
- Study completion
- Jul 1992 (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 examine the relationships of obesity and fat patterning with morbidity and mortality in Black Americans.
Detailed description
BACKGROUND:
Studies have shown that fat patterning is an important risk factor for diabetes and possibly cardiovascular diseases. The Secretary's Task Force on Black and Minority Health in 1985 concluded that diabetes and cardiovascular diseases were among the six causes of death that contribute most to the disparity in death rates between Blacks and whites, yet the relationship of fat patterning with these diseases was largely unstudied in Blacks. Since there are known racial differences in growth rates, body proportions, and adiposity, it cannot be assumed that studies done on whites are applicable to Blacks.
The Charleston Heart Study began in 1960 with the examination of a random sample of 2181 residents of Charleston County. Approximately one-third of the sample was Black. The cohort was re-examined in 1963-1964, 1974-1975, and 1984-1985, and the fifth recall involving physical examination, electrocardiogram, echocardiograph, plasma glucose and lipid assays, physical disability assessment, and 24-hour Holter monitoring was completed. In the 1963-1964 recall, 102 high socioeconomic status Black men were added to the cohort. Also, in the 1963-1964 recall a battery of anthropometric measurements were taken on about half the cohort and these measurements and others were included in the 1987-1988 recall. Thus height, weight, reported weight at age 25, circumference of the chest at inhale and exhale, circumference at the umbilicus and mid-arm circumference were available on the same individuals from the 1963-1964 and the 1987-1988 examinations. In addition, skinfolds at the triceps, biceps, subscapular, suprailiac and lower thigh and circumference at the hips were measured in the latter recall. The fifth examination was completed in 1989 under separate NHLBI grant support.
DESIGN NARRATIVE:
Cross-sectional relationships were estimated between anthropometric measures of body dimensions such as abdominal, central and upper body fat patterning, and total adiposity and the dependent variables of diabetes, blood pressure, plasma lipids and glucose, and left ventricular wall thickness. Anthropometric predictors of diabetes, blood pressure, plasma lipids and glucose, and left ventricular wall thickness were identified over a 24 year interval. Anthropometric predictors of survival were identified over a 25 year period with reference to mortality for coronary heart disease, cardiovascular disease, and all-cause mortality. Body dimensions were described by race and sex groups and changes in the shapes of individuals over a 24 year interval were examined. The importance of changes in anthropometric measurements with aging was determined for the prediction of diabetes, blood pressure, plasma lipids and glucose, left ventricular wall thickness, mortality from all causes and from coronary heart disease and cardiovascular disease.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
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 8227994Stevens J, Gautman SP, Keil JE. Body mass index and fat patterning as correlates of lipids and hypertension in an elderly, biracial population. J Gerontol. 1993 Nov;48(6):M249-54. doi: 10.1093/geronj/48.6.m249.
- Background: PubMed 2260547Stevens J, Keil JE, Waid LR, Gazes PC. Accuracy of current, 4-year, and 28-year self-reported body weight in an elderly population. Am J Epidemiol. 1990 Dec;132(6):1156-63. doi: 10.1093/oxfordjournals.aje.a115758.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Diseases and Diabetes Mellitus, 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 NCT00005248, which also lists 2 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.