Cardiovascular DiseasesNCT00005348
Adipose Distribution and Atherosclerosis
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To relate distribution of adipose tissue measured by a then new imaging technique, Magnetic Resonance Imaging (MRI) to extracranial carotid atherosclerosis, cardiovascular disease risk factors, and to more conventional measures of fat distribution such as body mass index (BMI) and waist/hip ratio. 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, Carotid Stenosis
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Apr 1991to Mar 1993
- 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 relate distribution of adipose tissue measured by a then new imaging technique, Magnetic Resonance Imaging (MRI) to extracranial carotid atherosclerosis, cardiovascular disease risk factors, and to more conventional measures of fat distribution such as body mass index (BMI) and waist/hip ratio. The primary hypothesis was that patients with extracranial carotid atherosclerosis (cases) had more intra-abdominal fat and a higher ratio of intra-abdominal fat to total or subcutaneous fat than age-sex-race matched controls.
Read the detailed description
BACKGROUND:
The study was ancillary to an NIH funded population-based project, the Atherosclerosis Risk in Communities Study (ARIC) that is ongoing in Forsyth County, North Carolina.
DESIGN NARRATIVE:
Using MRI, the investigators sought to demonstrate strong relationships between intra-abdominal fat and a number of cardiovascular disease risk factors, including history of hypertension, diabetes, cigarette smoking, family history of cardiovascular disease, plasma concentrations of triglyceride, high density lipoprotein (HDL) cholesterol, HDL2 cholesterol, apo A1, Apo B, postprandial lipid response to a fat rich meal, glucose, insulin, sex hormone binding globulin, and total and free testosterone. Certain other risk factors were less certain to show a relation to intra-abdominal fat as measured by MRI, including various hemostatic factors, as well as certain dietary factors such as consumption of alcohol, dietary fat, and cholesterol, but this research afforded an opportunity to explore these relationships. Finally, the investigators proposed to relate intra-abdominal fat to more conventional measures of fat distribution (waist/hip ratio, subscapular skinfold thickness, etc.) in an attempt to identify strong correlates of intra-abdominal fat that could be more easily measured.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) recor
- Conditions
- Cardiovascular Diseases, Heart Diseases, Carotid Stenosis
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Carotid Stenosis
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 startApr 1991
- Study completionMar 1993
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- NCT00005348
- Sponsor's protocol ID
- 4217
- Other IDs
- R01HL046208
- Status last verified
- Apr 2000
- First submitted
- 25 May 2000
- Last updated
- 13 May 2016
- Results posted
- No
Publications
Terry JG, Hinson WH, Evans GW, Schreiner PJ, Hagaman AP, Crouse JR 3rd. Evaluation of magnetic resonance imaging for quantification of intraabdominal fat in human beings by spin-echo and inversion-recovery protocols. Am J Clin Nutr. 1995 Aug;62(2):297-301. doi: 10.1093/ajcn/62.2.297.
PubMed 7625335
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adipose Distribution and Atherosclerosis
- ClinicalTrials.gov ID
- NCT00005348
- Acronym / sponsor ID
- 4217
- Conditions
- Cardiovascular Diseases, Heart Diseases, Carotid Stenosis
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Apr 1991
- Study completion
- Mar 1993 (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 relate distribution of adipose tissue measured by a then new imaging technique, Magnetic Resonance Imaging (MRI) to extracranial carotid atherosclerosis, cardiovascular disease risk factors, and to more conventional measures of fat distribution such as body mass index (BMI) and waist/hip ratio. The primary hypothesis was that patients with extracranial carotid atherosclerosis (cases) had more intra-abdominal fat and a higher ratio of intra-abdominal fat to total or subcutaneous fat than age-sex-race matched controls.
Detailed description
BACKGROUND:
The study was ancillary to an NIH funded population-based project, the Atherosclerosis Risk in Communities Study (ARIC) that is ongoing in Forsyth County, North Carolina.
DESIGN NARRATIVE:
Using MRI, the investigators sought to demonstrate strong relationships between intra-abdominal fat and a number of cardiovascular disease risk factors, including history of hypertension, diabetes, cigarette smoking, family history of cardiovascular disease, plasma concentrations of triglyceride, high density lipoprotein (HDL) cholesterol, HDL2 cholesterol, apo A1, Apo B, postprandial lipid response to a fat rich meal, glucose, insulin, sex hormone binding globulin, and total and free testosterone. Certain other risk factors were less certain to show a relation to intra-abdominal fat as measured by MRI, including various hemostatic factors, as well as certain dietary factors such as consumption of alcohol, dietary fat, and cholesterol, but this research afforded an opportunity to explore these relationships. Finally, the investigators proposed to relate intra-abdominal fat to more conventional measures of fat distribution (waist/hip ratio, subscapular skinfold thickness, etc.) in an attempt to identify strong correlates of intra-abdominal fat that could be more easily measured.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) recor
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 13 May 2016.
- Background: PubMed 7625335Terry JG, Hinson WH, Evans GW, Schreiner PJ, Hagaman AP, Crouse JR 3rd. Evaluation of magnetic resonance imaging for quantification of intraabdominal fat in human beings by spin-echo and inversion-recovery protocols. Am J Clin Nutr. 1995 Aug;62(2):297-301. doi: 10.1093/ajcn/62.2.297.
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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 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 13 May 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 NCT00005348, which also lists 1 linked publication.
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 13 May 2016.