Clinical trial NCT00005187: Cardiovascular Risk Profile Among Mexican-Americans
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Atherosclerosis
Heart Diseases
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2000-05-26
Enrollment: 2058
Sex: ALL
Minimum age (years): 7
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Mexican American residents of Starr County, Texas.

Brief summary: To characterize the epidemiology and genetics of apolipoproteins A-I, A-II, B, C-II, C-III, and E in a population of Mexican-Americans in Starr County, Texas.

Detailed description: BACKGROUND:

Evidence has established that the distribution and burden of several common chronic diseases among Mexican-Americans differ from that in the general population. These diseases include diabetes (almost exclusively noninsulin dependent diabetes), hypertension, and gallbladder disorders. While progress was made towards an elucidation of their epidemiology within this population, there was a paucity of data regarding other cardiovascular risk factors, most notably, the distribution of lipoproteins and their constituent apoproteins. With regard to the apolipoproteins, there were only minimal data from any population dealing with their distribution and relationships in the general population or pedigrees. This project provided as complete a profile on the distribution of metabolic cardiovascular risk factors as could be claimed for any other study of comparable size and provided baseline values for apo A-I, A-II, B, C-II, C-III and E.

DESIGN NARRATIVE:

One thousand randomly selected individuals were given a complete physical examination. From those 1,000, 100 probands with gallbladder disease were selected. Approximately 1,200 first degree relatives of the probands were invited to participate in the study and given a physical examination. Additionally, 100 control individuals, their spouses and first degree relatives were followed longitudinally for five years. Blood samples were obtained for determination of total cholesterol, LDL cholesterol, HDL2 and HDL3 cholesterol, and genetic markers. Data were collected on age, sex, body mass and fat distribution, diet, smoking, and alcohol consumption. Annual follow-up assessed the dynamics of changes in apolipoprotein levels and profiles and those factors which contributed to their change. The random and longitudinal data were combined with pedigree data to determine the effects of major genes, polygenes, and the environment on the variability of each apolipoprotein and on the relationship between these and other risk factors. An assessment was made in 100 individuals of the contribution of genetic variability at the DNA level in determining apolipoprotein levels.

Eligibility criteria: Participation in prior survey of Starr County, Texas where 1,004 representative individuals of the population aged 15 and older were selected. The community was first mapped and random blocks selected. All individuals in households on selected blocks were enumerated and then 1 age eligible individual from each household was selected for a complete physical evaluation. From these, 250 individuals were identified as probands and their, primarily, first degree relatives were selected for the same examination. 1,254 individuals were seen in this phase.

These individuals became eligible for the more complete profiling of apolipoproteins funded by the referenced grant.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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citation: Hanis CL, Hewett-Emmett D, Douglas TC, Schull WJ. Lipoprotein and apolipoprotein levels among Mexican-Americans in Starr County, Texas. Arterioscler Thromb. 1991 Jan-Feb;11(1):123-9. doi: 10.1161/01.atv.11.1.123.
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citation: Hanis CL, Hewett-Emmett D, Kubrusly LF, Maklad MN, Douglas TC, Mueller WH, Barton SA, Yoshimaru H, Kubrusly DB, Gonzalez R, et al. An ultrasound survey of gallbladder disease among Mexican Americans in Starr County, Texas: frequencies and risk factors. Ethn Dis. 1993 Winter;3(1):32-43.
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