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Understanding the Genetic Basis of Familial Combined Hyperlipidemia in Mexican Individuals

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00365235
First Posted: August 17, 2006
Last Update Posted: January 12, 2012
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.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Paivi Pajukanta, University of California, Los Angeles
  Purpose
Familial combined hyperlipidemia (FCHL) is an inherited disorder characterized by elevated levels of cholesterol and triglycerides; it often occurs in Mexican individuals with coronary heart disease (CHD). The purpose of this study is to identify the specific genes that predispose Mexican individuals to FCHL.

Condition
Hyperlipidemia, Familial Combined Coronary Disease

Study Type: Observational
Study Design: Observational Model: Family-Based
Time Perspective: Cross-Sectional
Official Title: Genetic Susceptibility to Common Lipid Disorders in Mexico

Further study details as provided by Paivi Pajukanta, University of California, Los Angeles:

Primary Outcome Measures:
  • Identifying the specific genes that predispose Mexican individuals to FCHL [ Time Frame: Measured through the use of genetic samples ]

Biospecimen Retention:   Samples With DNA
Whole blood sample is taken from all participants and adipose tissue sample from a subgroup.

Enrollment: 998
Study Start Date: July 2006
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Detailed Description:

CHD is the leading cause of death in Mexico. Dyslipidemia that is characterized by high total cholesterol, high triglycerides, and low "good" high-density lipoprotein (HDL) cholesterol is a risk factor for developing CHD. Research has shown that the Mexican population has an increased tendency towards dyslipidemia, but it is not known what genetic factors contribute to this predisposition. This study will examine the genetic basis of FCHL, which is an inherited form of dyslipidemia characterized by elevated levels of total cholesterol and triglycerides. FCHL is a major contributing factor in CHD; 20% of individuals with CHD under the age of 60 have FCHL. The purpose of this study is to identify and characterize the specific DNA sequence variations that predispose Mexican individuals to FCHL. Results of this study may aid in the development of appropriate prevention and screening techniques.

This study will enroll individuals in Mexico who have FCHL. Participants will attend one study visit for blood collection and DNA sampling. Family members of participants will be contacted and asked to provide a DNA sample also. A select group of participants will return for a second study visit for RNA sampling. Study researchers will analyze participants' DNA and RNA samples, as well as two FCHL genes identified in previous research studies.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Study subjects are Mexicans visiting the Dyslipidemia Clinic at the Instituto Nacional de Ciencias Medicas y Nutricion, Salvador Zubiran, Mexico City, and their family members
Criteria

Inclusion Criteria:

  • Elevated levels of serum total cholesterol, triglycerides, or both
  • Elevated levels of serum apolipoprotein B (using the Mexican population percentiles)

Exclusion Criteria:

  • Tendon xanthomas
  • Kidney disease
  • Thyroid disorder
  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): NCT00365235


Locations
Mexico
Instituto Nacional De Ciencias Medicas y Nutricion
Mexico City, Mexico, 14000
Sponsors and Collaborators
University of California, Los Angeles
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Paivi E. Pajukanta, MD, PhD David Geffen School of Medicine at UCLA, Department of Human Genetics
  More Information

Responsible Party: Paivi Pajukanta, Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00365235     History of Changes
Other Study ID Numbers: 1348
R01HL082762-01A1 ( U.S. NIH Grant/Contract )
First Submitted: August 16, 2006
First Posted: August 17, 2006
Last Update Posted: January 12, 2012
Last Verified: January 2012

Additional relevant MeSH terms:
Hyperlipidemias
Hyperlipoproteinemias
Coronary Disease
Coronary Artery Disease
Hyperlipidemia, Familial Combined
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn