Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Information provided by (Responsible Party):
Lars Berglund, MD, University of California, Davis Identifier:
First received: February 25, 2009
Last updated: February 6, 2015
Last verified: February 2015

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 Intervention
Heart Disease
Other: No intervention, observational study

Study Type: Observational
Study Design: Observational Model: Family-Based
Time Perspective: Cross-Sectional
Official Title: Regulation of Lipoprotein(a) Metabolism in Humans With Reference to Ethnicity

Resource links provided by NLM:

Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Genetic variation of Lp(a) levels in each group [ Time Frame: five years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

plasma, DNA, white blood cell

Enrollment: 325
Study Start Date: February 2009
Study Completion Date: December 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
African American Families
Families with 2 parents and 2 children - no intervention, observational study
Other: No intervention, observational study
Not applicable
Caucasian Families
Families with 2 parents and 2 children - no intervention, observational study
Other: No intervention, observational study
Not applicable

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.


Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
Principal Investigator: Lars Berglund, M.D., Ph.D. University of California, Davis
  More Information

Additional Information:
No publications provided

Responsible Party: Lars Berglund, MD, Director, UC Davis CTSC, University of California, Davis Identifier: NCT00853775     History of Changes
Other Study ID Numbers: 200816533-2, 2R01HL062705-05A2
Study First Received: February 25, 2009
Last Updated: February 6, 2015
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases processed this record on February 27, 2015