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Family Research Study: Metabolism of Fats and Proteins in Specific Ethnic Groups

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00853775
Recruitment Status : Completed
First Posted : March 2, 2009
Last Update Posted : May 30, 2017
Information provided by (Responsible Party):

Study Description
Brief 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. 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.

Condition or disease Intervention/treatment
Healthy Heart Disease Other: No intervention, observational study

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

Study Type : Observational
Actual Enrollment : 325 participants
Observational Model: Family-Based
Time Perspective: Cross-Sectional
Official Title: Regulation of Lipoprotein(a) Metabolism in Humans With Reference to Ethnicity
Study Start Date : February 2009
Primary Completion Date : May 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
African American Families
Families with 2 parents and 2 children - no intervention, observational study
Other: No intervention, observational study
Caucasian Families
Families with 2 parents and 2 children - no intervention, observational study
Other: No intervention, observational study

Outcome Measures

Primary Outcome Measures :
  1. Genetic variation of Lp(a) levels in each group [ Time Frame: five years ]

Biospecimen Retention:   Samples With DNA
plasma, DNA, white blood cell

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.

Inclusion Criteria:

  • Of Caucasian or African descent
  • Families must have 2 natural/biological parents and 2 natural/biological offspring
  • 6 years old or older

Exclusion Criteria:

  • Races other than African American or Caucasian
  • Families without 2 natural/biological parents and 2 natural/biological offspring
  • younger that 6 years old
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00853775

United States, California
UC Davis CTSC Clinical Research Center (CCRC) at Veterans Affair Medical Center
Mather, California, United States, 95655
Sponsors and Collaborators
University of California, Davis
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Lars Berglund, M.D., Ph.D. University of California, Davis
More Information

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT00853775     History of Changes
Other Study ID Numbers: 200816533
2R01HL062705-05A2 ( U.S. NIH Grant/Contract )
First Posted: March 2, 2009    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017

Keywords provided by University of California, Davis:
heart disease
cardiovascular disease

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases