HealthyNCT00853775
Family Research Study: Metabolism of Fats and Proteins in Specific Ethnic Groups
An observational study of Healthy and Heart Disease, run by University of California, Davis at 1 site in United States.
Trial summary
The purpose of this study is to determine whether lipoprotein(a), also called Lp(a), is a risk factor for cardiovascular (heart) disease. Lipoproteins are tiny particles that circulate in the blood. They contain cholesterol, fat, and protein in varying amounts depending on the body's need. Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy, Heart Disease
- How many people
- 325 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Dec 2012
- 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 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: We are recruiting 100 African American and 100 Caucasian families. The families that will be recruited will have two natural parents and two natural offspring.
Who may be able to join
- Of Caucasian or African descent
- Families must have 2 natural/biological parents and 2 natural/biological offspring
- 6 years old or older
Who cannot join
- Races other than African American or Caucasian
- Families without 2 natural/biological parents and 2 natural/biological offspring
- younger that 6 years old
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis CTSC Clinical Research Center (CCRC) at Veterans Affair Medical Center
Mather, California, 95655
About this study
Official title: Regulation of Lipoprotein(a) Metabolism in Humans With Reference to Ethnicity
The purpose of this study is to determine whether lipoprotein(a), also called Lp(a), is a risk factor for cardiovascular (heart) disease. Lipoproteins are tiny particles that circulate in the blood. They contain cholesterol, fat, and protein in varying amounts depending on the body's need. Higher levels of lipoproteins in the blood can cause an increased risk of heart disease.
The investigators believe that by studying the Lp(a) lipoprotein in Caucasians and African Americans, the investigators can assess for genetic variation factors related to cardiovascular (heart) disease. The investigators will be looking at 100 African-American families and 100 Caucasian families to confirm whether a higher Lp(a) level is an indicator of a higher risk for heart disease.
Read the detailed description
During the study visit the research staff will ask about the medical history, perform a brief physical exam, and draw approximately 4 teaspoons of blood of each family member.
- Conditions
- Healthy, Heart Disease
- Being tested
- No intervention, observational study
- Keywords
- heart disease, cardiovascular disease, lipoproteins, lipoprotein(a), Lp(a), apolipoprotein(a), apo(a), fats, proteins, metabolism
- Medical subject headings
- Heart Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention, observational studyOther
| Study group | Role | What they receive |
|---|---|---|
| African American Families | Families with 2 parents and 2 children - no intervention, observational study Receives: Other: No intervention, observational study | |
| Caucasian Families | Families with 2 parents and 2 children - no intervention, observational study Receives: Other: No intervention, observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genetic variation of Lp(a) levels in each group
Measured: five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2009 (estimated)
- Study startFeb 2009
- Primary completionMay 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Enrolment
- 325 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Lars Berglund, M.D., Ph.D., Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00853775
- Sponsor's protocol ID
- 200816533
- Other IDs
- 2R01HL062705-05A2
- Status last verified
- May 2017
- First submitted
- 25 Feb 2009
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regulation of Lipoprotein(a) Metabolism in Humans With Reference to Ethnicity
- ClinicalTrials.gov ID
- NCT00853775
- Acronym / sponsor ID
- 200816533
- Conditions
- Healthy, Heart Disease
- Keywords
- heart disease, cardiovascular disease, lipoproteins, lipoprotein(a), Lp(a), apolipoprotein(a), apo(a), fats
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 325 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Feb 2009
- Primary completion
- May 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 2 Mar 2009 (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.
The purpose of this study is to determine whether lipoprotein(a), also called Lp(a), is a risk factor for cardiovascular (heart) disease. Lipoproteins are tiny particles that circulate in the blood. They contain cholesterol, fat, and protein in varying amounts depending on the body's need. Higher levels of lipoproteins in the blood can cause an increased risk of heart disease.
The investigators believe that by studying the Lp(a) lipoprotein in Caucasians and African Americans, the investigators can assess for genetic variation factors related to cardiovascular (heart) disease. The investigators will be looking at 100 African-American families and 100 Caucasian families to confirm whether a higher Lp(a) level is an indicator of a higher risk for heart disease.
Detailed description
During the study visit the research staff will ask about the medical history, perform a brief physical exam, and draw approximately 4 teaspoons of blood of each family member.
Study design
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| African American Families | – | Other: No intervention, observational studyFamilies with 2 parents and 2 children - no intervention, observational study |
| Caucasian Families | – | Other: No intervention, observational studyFamilies with 2 parents and 2 children - no intervention, observational study |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- We are recruiting 100 African American and 100 Caucasian families. The families that will be recruited will have two natural parents and two natural offspring.
Key inclusion criteria (3 listed)
- Of Caucasian or African descent
- Families must have 2 natural/biological parents and 2 natural/biological offspring
- 6 years old or older
Key exclusion criteria (3 listed)
- Races other than African American or Caucasian
- Families without 2 natural/biological parents and 2 natural/biological offspring
- younger that 6 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention, observational study | Other | African American Families, Caucasian Families |
Primary outcome
Genetic variation of Lp(a) levels in each group
Time frame: five years
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 30 May 2017.
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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.
Lars Berglund, M.D., Ph.D. principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy and Heart Disease, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. 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 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does the primary outcome measure?
Genetic variation of Lp(a) levels in each group (time frame: five years). It is what the study was designed to measure, not a finding.
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 30 May 2017.