AtherosclerosisNCT00005405
Parity and Serum Lipids in White and Hispanic Women
An observational study of Atherosclerosis and Cardiovascular Diseases, run by University of Pennsylvania.
Trial summary
To analyze the relationships between parity (childbirth) or gravidity (pregnancy) and measures of lipids in groups of women from the Hispanic Health and Nutrition Examination Survey (Hispanic HANES) and the Framingham Heart Study. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Atherosclerosis, Cardiovascular Diseases, Heart Diseases
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 1991to Sep 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 analyze the relationships between parity (childbirth) or gravidity (pregnancy) and measures of lipids in groups of women from the Hispanic Health and Nutrition Examination Survey (Hispanic HANES) and the Framingham Heart Study.
Read the detailed description
BACKGROUND:
The relationships between parity or gravidity and measures of lipids in groups of women from the Hispanic Health and Nutrition Examination Survey (Hispanic HANES) and the Framingham Heart Study offered insights into the health of an important minority group in the United States and provided clues regarding hormonal mechanisms in lipoprotein metabolism.
DESIGN NARRATIVE:
In the Framingham cohort, the relationships among gravidity, LDL-cholesterol, HDL-cholesterol and total cholesterol were prospectively studied. Each of these serum lipids was tested as a potential mediator of associations between gravidity and various cardiovascular endpoints. In the Hispanic HANES, the associations among parity, gravidity, and lipid levels were examined in cross-sectional data on women of a different ethnic background in whom birth rates tended to be high. Secondary analysis of these two datasets was conducted, carefully considering aspects of the study designs. Bivariate analyses generated mean lipid levels within parity or gravidity groups. HDL, LDL, and total cholesterol were then stratified both by parity and other variables (such as age and smoking status) so that interactions could be considered. Multivariate analyses were used to analyze the effect of parity on lipids and cardiovascular disease events while controlling for a variety of potentially confounding factors (such as body mass index, subscapular/triceps, skinfold ratio, education, income, cigarette smoking, alcohol consumption, oral contraceptive use, estrogen replacement therapy, menopausal status and type of menopause). Interactions were also considered in multivariate models.
- Conditions
- Atherosclerosis, Cardiovascular Diseases, Heart Diseases
- Medical subject headings
- Atherosclerosis, Cardiovascular Diseases, Heart Diseases
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 1991
- Primary completionSep 1993
- Study completionSep 1993
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005405
- Sponsor's protocol ID
- 4322
- Other IDs
- R03HL046168
- Status last verified
- Jan 2016
- First submitted
- 25 May 2000
- Last updated
- 20 Jan 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parity and Serum Lipids in White and Hispanic Women
- ClinicalTrials.gov ID
- NCT00005405
- Acronym / sponsor ID
- 4322
- Conditions
- Atherosclerosis, Cardiovascular Diseases, Heart Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Sep 1991
- Primary completion
- Sep 1993 (actual)
- Study completion
- Sep 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 analyze the relationships between parity (childbirth) or gravidity (pregnancy) and measures of lipids in groups of women from the Hispanic Health and Nutrition Examination Survey (Hispanic HANES) and the Framingham Heart Study.
Detailed description
BACKGROUND:
The relationships between parity or gravidity and measures of lipids in groups of women from the Hispanic Health and Nutrition Examination Survey (Hispanic HANES) and the Framingham Heart Study offered insights into the health of an important minority group in the United States and provided clues regarding hormonal mechanisms in lipoprotein metabolism.
DESIGN NARRATIVE:
In the Framingham cohort, the relationships among gravidity, LDL-cholesterol, HDL-cholesterol and total cholesterol were prospectively studied. Each of these serum lipids was tested as a potential mediator of associations between gravidity and various cardiovascular endpoints. In the Hispanic HANES, the associations among parity, gravidity, and lipid levels were examined in cross-sectional data on women of a different ethnic background in whom birth rates tended to be high. Secondary analysis of these two datasets was conducted, carefully considering aspects of the study designs. Bivariate analyses generated mean lipid levels within parity or gravidity groups. HDL, LDL, and total cholesterol were then stratified both by parity and other variables (such as age and smoking status) so that interactions could be considered. Multivariate analyses were used to analyze the effect of parity on lipids and cardiovascular disease events while controlling for a variety of potentially confounding factors (such as body mass index, subscapular/triceps, skinfold ratio, education, income, cigarette smoking, alcohol consumption, oral contraceptive use, estrogen replacement therapy, menopausal status and type of menopause). Interactions were also considered in multivariate models.
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 20 Jan 2016.
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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 Atherosclerosis and Cardiovascular Diseases, run by University of Pennsylvania.
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 20 Jan 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?
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 20 Jan 2016.