Understanding the Genetic Basis of Familial Combined Hyperlipidemia in Mexican Individuals

Sponsor

University of California, Los Angeles (Other)

Overall Status

Completed

CT.gov ID

NCT00365235

Collaborator

National Heart, Lung, and Blood Institute (NHLBI) (NIH)

998

Enrollment

Location

Duration (Months)

16.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Hyperlipidemia, Familial Combined Coronary Disease

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.

Study Design

Study Type:

Observational

Actual Enrollment :

998 participants

Observational Model:

Family-Based

Time Perspective:

Cross-Sectional

Official Title:

Genetic Susceptibility to Common Lipid Disorders in Mexico

Study Start Date :

Jul 1, 2006

Actual Primary Completion Date :

Jun 1, 2011

Actual Study Completion Date :

Jun 1, 2011

Outcome Measures

Primary Outcome Measures

Identifying the specific genes that predispose Mexican individuals to FCHL [Measured through the use of genetic samples]

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Paivi Pajukanta, Professor, University of California, Los Angeles

ClinicalTrials.gov Identifier:

NCT00365235

Other Study ID Numbers:

1348
R01HL082762-01A1

First Posted:

Aug 17, 2006

Last Update Posted:

Jan 12, 2012

Last Verified:

Jan 1, 2012

Additional relevant MeSH terms:

Coronary Disease

Hyperlipidemia, Familial Combined

Hyperlipidemias

Hyperlipoproteinemias

Study Results

No Results Posted as of Jan 12, 2012