Cardiovascular DiseasesNCT00005187
Cardiovascular Risk Profile Among Mexican-Americans
An observational study of Cardiovascular Diseases and Atherosclerosis, run by The University of Texas Health Science Center, Houston.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 100 years
- Conditions the study is for
- Cardiovascular Diseases, Atherosclerosis, Heart Diseases
- How many people
- 2,058 participants
- Where
- No sites listed yet
- Study dates
- Apr 1986to Mar 1992
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Mexican American residents of Starr County, Texas.
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.
About this study
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.
Read the 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.
- Conditions
- Cardiovascular Diseases, Atherosclerosis, Heart Diseases
- Medical subject headings
- Cardiovascular Diseases, Atherosclerosis, Heart Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startApr 1986
- Primary completionMar 1992
- Study completionMar 1992
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 2,058 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Craig L Hanis, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005187
- Sponsor's protocol ID
- 1065
- Other IDs
- R01HL034823
- Status last verified
- Apr 2019
- First submitted
- 25 May 2000
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Reichley KB, Mueller WH, Hanis CL, Joos SK, Tulloch BR, Barton S, Schull WJ. Centralized obesity and cardiovascular disease risk in Mexican Americans. Am J Epidemiol. 1987 Mar;125(3):373-86. doi: 10.1093/oxfordjournals.aje.a114544.
PubMed 3812446Mueller WH, Wear ML, Hanis CL, Barton SA, Schull WJ. Body circumferences as alternatives to skinfold measurements of body fat distribution in Mexican-Americans. Int J Obes. 1987;11(4):309-18.
PubMed 3667064Chakraborty R, Hanis CL. Non-random sampling in human genetics: estimation of familial correlations, model testing, and interpretation. Stat Med. 1987 Jul-Aug;6(5):629-46. doi: 10.1002/sim.4780060511.
PubMed 3659672Schull WJ and Hanis CL: Genetic Versus Environmental Influences on Disease: Perspectives from Obesity. In: Cruickshank K, Beevers DG (Eds), Ethnic Factors in Health and Disease. Hertfordshire, England: John Wright Medical Publishers. 1989.
Hanis CL and Schull WJ: Diabetes Among Mexican-Americans in Starr County, Texas: Definition and Disease. In: Diabetes Among Mexican-Americans in Texas. Austin, Texas: The Texas Diabetes Council, 1987
Boerwinkle E, Hanis CL, Chan L. A unique length polymorphism in the signal peptide region of the apolipoprotein B gene in Mexican-Americans. Nucleic Acids Res. 1990 Dec 11;18(23):7193. doi: 10.1093/nar/18.23.7193.
PubMed 2263508Hanis CL, Bertin TK. Identification of an insulin receptor exon 8 NsiI polymorphism using the polymerase chain reaction. Nucleic Acids Res. 1990 Oct 11;18(19):5923. doi: 10.1093/nar/18.19.5923. No abstract available.
PubMed 1977145Boerwinkle E, Chen SH, Visvikis S, Hanis CL, Siest G, Chan L. Signal peptide-length variation in human apolipoprotein B gene. Molecular characteristics and association with plasma glucose levels. Diabetes. 1991 Nov;40(11):1539-44. doi: 10.2337/diab.40.11.1539.
PubMed 1936612Hanis CL, Douglas TC, Hewett-Emmett D. Apolipoprotein A-IV protein polymorphism: frequency and effects on lipids, lipoproteins, and apolipoproteins among Mexican-Americans in Starr County, Texas. Hum Genet. 1991 Jan;86(3):323-5. doi: 10.1007/BF00202422.
PubMed 1997391Hanis 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.
PubMed 1987989Schull WJ, Hanis CL. Genetics and public health in the 1990s. Annu Rev Public Health. 1990;11:105-25. doi: 10.1146/annurev.pu.11.050190.000541. No abstract available.
PubMed 2191654Hanis 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.
PubMed 8508103Hanis CL, Hewett-Emmett D, Douglas TC, Bertin TK, Schull WJ. Effects of the apolipoprotein E polymorphism on levels of lipids, lipoproteins, and apolipoproteins among Mexican-Americans in Starr County, Texas. Arterioscler Thromb. 1991 Mar-Apr;11(2):362-70. doi: 10.1161/01.atv.11.2.362.
PubMed 1998654
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Risk Profile Among Mexican-Americans
- ClinicalTrials.gov ID
- NCT00005187
- Acronym / sponsor ID
- 1065
- Conditions
- Cardiovascular Diseases, Atherosclerosis, Heart Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,058 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Apr 1986
- Primary completion
- Mar 1992 (actual)
- Study completion
- Mar 1992 (actual)
- First posted
- 26 May 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 7 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Mexican American residents of Starr County, Texas.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
- Background: PubMed 3812446Reichley KB, Mueller WH, Hanis CL, Joos SK, Tulloch BR, Barton S, Schull WJ. Centralized obesity and cardiovascular disease risk in Mexican Americans. Am J Epidemiol. 1987 Mar;125(3):373-86. doi: 10.1093/oxfordjournals.aje.a114544.
- Background: PubMed 3667064Mueller WH, Wear ML, Hanis CL, Barton SA, Schull WJ. Body circumferences as alternatives to skinfold measurements of body fat distribution in Mexican-Americans. Int J Obes. 1987;11(4):309-18.
- Background: PubMed 3659672Chakraborty R, Hanis CL. Non-random sampling in human genetics: estimation of familial correlations, model testing, and interpretation. Stat Med. 1987 Jul-Aug;6(5):629-46. doi: 10.1002/sim.4780060511.
- BackgroundSchull WJ and Hanis CL: Genetic Versus Environmental Influences on Disease: Perspectives from Obesity. In: Cruickshank K, Beevers DG (Eds), Ethnic Factors in Health and Disease. Hertfordshire, England: John Wright Medical Publishers. 1989.
- BackgroundHanis CL and Schull WJ: Diabetes Among Mexican-Americans in Starr County, Texas: Definition and Disease. In: Diabetes Among Mexican-Americans in Texas. Austin, Texas: The Texas Diabetes Council, 1987
- Background: PubMed 2263508Boerwinkle E, Hanis CL, Chan L. A unique length polymorphism in the signal peptide region of the apolipoprotein B gene in Mexican-Americans. Nucleic Acids Res. 1990 Dec 11;18(23):7193. doi: 10.1093/nar/18.23.7193.
- Background: PubMed 1977145Hanis CL, Bertin TK. Identification of an insulin receptor exon 8 NsiI polymorphism using the polymerase chain reaction. Nucleic Acids Res. 1990 Oct 11;18(19):5923. doi: 10.1093/nar/18.19.5923. No abstract available.
- Background: PubMed 1936612Boerwinkle E, Chen SH, Visvikis S, Hanis CL, Siest G, Chan L. Signal peptide-length variation in human apolipoprotein B gene. Molecular characteristics and association with plasma glucose levels. Diabetes. 1991 Nov;40(11):1539-44. doi: 10.2337/diab.40.11.1539.
- Background: PubMed 1997391Hanis CL, Douglas TC, Hewett-Emmett D. Apolipoprotein A-IV protein polymorphism: frequency and effects on lipids, lipoproteins, and apolipoproteins among Mexican-Americans in Starr County, Texas. Hum Genet. 1991 Jan;86(3):323-5. doi: 10.1007/BF00202422.
- Background: PubMed 1987989Hanis 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.
- Background: PubMed 2191654Schull WJ, Hanis CL. Genetics and public health in the 1990s. Annu Rev Public Health. 1990;11:105-25. doi: 10.1146/annurev.pu.11.050190.000541. No abstract available.
- Background: PubMed 8508103Hanis 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Atherosclerosis, run by The University of Texas Health Science Center, Houston.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005187, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2019.