Cardiovascular DiseasesNCT00005255
Ischemic Heart Disease Incidence and Indices of Body-fat Distribution
An observational study of Cardiovascular Diseases and Coronary Disease, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To determine the association between ischemic heart disease incidence and anthropometric indices of body-fat distribution. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Coronary Disease, Heart Diseases
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- May 1990to Apr 1995
- 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 determine the association between ischemic heart disease incidence and anthropometric indices of body-fat distribution.
Read the detailed description
BACKGROUND:
Previous studies have demonstrated that abdominal obesity can be predictive of ischemic heart disease. These prospective cohort studies employed simple indices of body-fat distribution such as waist-to-hip circumference ratio or subscapular skinfold. Their similar results suggested that increased abdominal obesity conferred a two-fold increased risk of ischemic heart disease among middle-aged men. The two proposed studies permitted testing of alternative fat-distribution indices which might be stronger risk factors for ischemic heart disease incidence than the waist-to-hip-ratio or the subscapular skinfold.
DESIGN NARRATIVE:
Two parallel case-control studies were conducted. In both studies, subjects were measured for girth, skinfold, abdominal sagittal diameter, height, and weight. Analyses for both protocols considered men and women separately. Possible confounders of the association between fat-distribution indices and ischemic heart disease were considered and if required, adjusted for in multivariate analyses. Possible confounders included race, age, tobacco use, alcohol use, diabetes, social class, hypertension, cholesterol levels, and physical activity levels.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
- Medical subject headings
- Cardiovascular Diseases, Coronary Disease, Heart Diseases, Myocardial Ischemia, 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 startMay 1990
- Study completionApr 1995
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005255
- Sponsor's protocol ID
- 1137
- Other IDs
- R01HL040844
- Status last verified
- May 2000
- First submitted
- 25 May 2000
- Last updated
- 18 Feb 2016
- Results posted
- No
Publications
Kahn HS, Williamson DF. Abdominal obesity and mortality risk among men in nineteenth-century North America. Int J Obes Relat Metab Disord. 1994 Oct;18(10):686-91.
PubMed 7866464Kahn HS. Choosing an index for abdominal obesity: an opportunity for epidemiologic clarification. J Clin Epidemiol. 1993 May;46(5):491-4. doi: 10.1016/0895-4356(93)90027-x.
PubMed 8369048Kahn HS, Simoes EJ, Koponen M, Hanzlick R. The abdominal diameter index and sudden coronary death in men. Am J Cardiol. 1996 Oct 15;78(8):961-4. doi: 10.1016/s0002-9149(96)00479-1.
PubMed 8888678Kahn HS. The accumulation of visceral adipose tissue may be influenced by intra-abdominal temperature. Obes Res. 1996 May;4(3):297-9. doi: 10.1002/j.1550-8528.1996.tb00550.x.
PubMed 8732966Kahn HS, Austin H, Williamson DF, Arensberg D. Simple anthropometric indices associated with ischemic heart disease. J Clin Epidemiol. 1996 Sep;49(9):1017-24. doi: 10.1016/0895-4356(96)00113-8.
PubMed 8780611
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
- Ischemic Heart Disease Incidence and Indices of Body-fat Distribution
- ClinicalTrials.gov ID
- NCT00005255
- Acronym / sponsor ID
- 1137
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- May 1990
- Study completion
- Apr 1995 (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 determine the association between ischemic heart disease incidence and anthropometric indices of body-fat distribution.
Detailed description
BACKGROUND:
Previous studies have demonstrated that abdominal obesity can be predictive of ischemic heart disease. These prospective cohort studies employed simple indices of body-fat distribution such as waist-to-hip circumference ratio or subscapular skinfold. Their similar results suggested that increased abdominal obesity conferred a two-fold increased risk of ischemic heart disease among middle-aged men. The two proposed studies permitted testing of alternative fat-distribution indices which might be stronger risk factors for ischemic heart disease incidence than the waist-to-hip-ratio or the subscapular skinfold.
DESIGN NARRATIVE:
Two parallel case-control studies were conducted. In both studies, subjects were measured for girth, skinfold, abdominal sagittal diameter, height, and weight. Analyses for both protocols considered men and women separately. Possible confounders of the association between fat-distribution indices and ischemic heart disease were considered and if required, adjusted for in multivariate analyses. Possible confounders included race, age, tobacco use, alcohol use, diabetes, social class, hypertension, cholesterol levels, and physical activity levels.
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 7866464Kahn HS, Williamson DF. Abdominal obesity and mortality risk among men in nineteenth-century North America. Int J Obes Relat Metab Disord. 1994 Oct;18(10):686-91.
- Background: PubMed 8369048Kahn HS. Choosing an index for abdominal obesity: an opportunity for epidemiologic clarification. J Clin Epidemiol. 1993 May;46(5):491-4. doi: 10.1016/0895-4356(93)90027-x.
- Background: PubMed 8888678Kahn HS, Simoes EJ, Koponen M, Hanzlick R. The abdominal diameter index and sudden coronary death in men. Am J Cardiol. 1996 Oct 15;78(8):961-4. doi: 10.1016/s0002-9149(96)00479-1.
- Background: PubMed 8732966Kahn HS. The accumulation of visceral adipose tissue may be influenced by intra-abdominal temperature. Obes Res. 1996 May;4(3):297-9. doi: 10.1002/j.1550-8528.1996.tb00550.x.
- Background: PubMed 8780611Kahn HS, Austin H, Williamson DF, Arensberg D. Simple anthropometric indices associated with ischemic heart disease. J Clin Epidemiol. 1996 Sep;49(9):1017-24. doi: 10.1016/0895-4356(96)00113-8.
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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 Cardiovascular Diseases and Coronary Disease, 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 NCT00005255, which also lists 5 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.