Clinical trial NCT00365235: Understanding the Genetic Basis of Familial Combined Hyperlipidemia in Mexican Individuals
Official title: Genetic Susceptibility to Common Lipid Disorders in Mexico
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperlipidemia, Familial Combined
Coronary Disease
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2006-08-17
Enrollment: 998
Sex: ALL
Minimum age (years): 10
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: CROSS_SECTIONAL
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

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.

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 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

Primary outcomes:
measure: Identifying the specific genes that predispose Mexican individuals to FCHL
timeFrame: Measured through the use of genetic samples
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Instituto Nacional De Ciencias Medicas y Nutricion
Study officials:
affiliation: David Geffen School of Medicine at UCLA, Department of Human Genetics
name: Paivi E. Pajukanta, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: