Understanding the Genetic Basis of Familial Combined Hyperlipidemia in Mexican Individuals

Coronary Disease Clinical Trial

Official title:

Genetic Susceptibility to Common Lipid Disorders in Mexico

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00365235
• Other study ID #: 1348
• Secondary ID: R01HL082762-01A1
• Status: Completed
• Phase: N/A
• First received: August 16, 2006
• Last updated: January 11, 2012
• Start date: July 2006
• Est. completion date: June 2011

Study information

• Verified date: January 2012
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 998
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 10 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Family-Based, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Hyperlipidemia, Familial Combined
• Hyperlipidemias

Locations

Country	Name	City	State
Mexico	Instituto Nacional De Ciencias Medicas y Nutricion	Mexico City

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identifying the specific genes that predispose Mexican individuals to FCHL		Measured through the use of genetic samples	No