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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2010 by University of California, Davis
Sponsor:
Collaborators:
Information provided by:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00853775
First received: February 25, 2009
Last updated: February 1, 2010
Last verified: January 2010
  Purpose

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
Healthy
Heart Disease

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


Estimated Enrollment: 800
Study Start Date: February 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
African American Families
Caucasian Families

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.

  Eligibility

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.

Criteria

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 ClinicalTrials.gov identifier: NCT00853775

Contacts
Contact: Tina Tran 916-703-9127

Locations
United States, California
UC Davis CTSC Clinical Research Center (CCRC) at Veterans Affair Medical Center Recruiting
Mather, California, United States, 95655
Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: Lars Berglund, M.D., Ph.D. University of California, Davis
  More Information

Additional Information:
No publications provided

Responsible Party: Lars Berglund, M.D., Ph.D., University of California, Davis
ClinicalTrials.gov Identifier: NCT00853775     History of Changes
Other Study ID Numbers: 200816533-2, 2R01HL062705-05A2
Study First Received: February 25, 2009
Last Updated: February 1, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Davis:
heart disease
cardiovascular disease
lipoproteins
lipoprotein(a)
Lp(a)
apolipoprotein(a)
apo(a)
fats
proteins
metabolism

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 01, 2014