Cardiovascular DiseasesNCT00005205
Incidence of Diabetes and Cardiovascular Disease in Mexican Americans
An observational study of Cardiovascular Diseases and Heart Diseases, run by The University of Texas Health Science Center at San Antonio.
Trial summary
To determine the incidence of type II diabetes and cardiovascular disease among Mexican-American and non-Hispanic whites in a 15 to 24 year follow-up of the San Antonio Heart Study 1 participants. Also, to perform a 15 to 24 year mortality follow-up of the cohort and to examine the "Hispanic paradox". Read more about this study
- Who is it for?
- Ages 24 to 64 years
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Myocardial Infarction
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Aug 1987to Jul 2003
- 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 24 to 64 years
- All sexes
- No healthy volunteers
- Adult
No eligibility criteria
About this study
To determine the incidence of type II diabetes and cardiovascular disease among Mexican-American and non-Hispanic whites in a 15 to 24 year follow-up of the San Antonio Heart Study 1 participants. Also, to perform a 15 to 24 year mortality follow-up of the cohort and to examine the "Hispanic paradox".
Read the detailed description
BACKGROUND:
The San Antonio Heart Study 1 was a population-based survey of diabetes and cardiovascular risk factors in Mexican Americans and non-Hispanic whites conducted from 1979 to 1982. Participants included all men and non-pregnant women ages 24 to 64, who resided in households randomly sampled from three socio-culturally distinct neighborhoods of San Antonio. The low-income barrio residents were almost exclusively traditional Mexican-Americans. The middle-income neighborhood was ethnically balanced with equal numbers of Mexican Americans and Anglos whereas the upper income suburb was approximately 90 percent Anglo. Risk factors measured included obesity, glucose intolerance, hypertriglyceridemia, low levels of high density lipoprotein cholesterol, and blood pressure. The total number of people who were examined medically was 2,386, divided as follows: 1,288 Mexican Americans; 929 Anglos; and 169 other Hispanics such as Cubans. The San Antonio Heart Study 1 was designed to test the hypothesis that as Mexican Americans became progressively more affluent and accultured to mainstream United States culture, they would gradually lose their diabetic pattern of cardiovascular risk factors of obesity, diabetes, and hypertriglyceridemia.
Mexican Americans are the second largest minority group in the United States. Despite this, as recently as 1977, little was known about their health status. In recent years this situation has begun to change with publication of results from several major studies including the San Antonio Heart Study, the Starr County Study, and most recently the Hispanic Health and Nutrition Examination Survey (HHANES).
DESIGN NARRATIVE:
Beginning in 1987, each participant in the prospective San Antonio Heart Study 1 was recalled as close as possible to the eighth anniversary of his or her baseline examination and re-examined. Subjects had fasting lipid and lipoprotein determinations, a glucose tolerance test to diagnose incident cases of non-insulin dependent diabetes mellitus according to the National Diabetes Data Group criteria, blood pressure measurements, a resting electrocardiogram, and completed a questionnaire to elicit information on possible cardiovascular endpoints. Medical records were obtained to document the endpoints. Subjects with a history of peripheral vascular disease or diabetes had ankle/arm blood pressure ratios determined before and after exercise. Deaths were ascertained in the course of routine follow-up supplemented by search of state health department and National Death Index records. Death certificates were requested and for those certificates indicating diabetes or cardiovascular disease as the cause of death, hospital or physician records were requested and reviewed. Standardized criteria were used to validate cause of death. Endpoints included diabetes, sudden cardiac death, non-fatal (including silent) myocardial infarction, angina pectoris, cerebrovascular and peripheral vascular disease. The study was renewed in 1992 to continue follow-up.
The study was renewed in 1998 to perform a 15 to 24 year mortality follow-up of the cohort. Time dependencies in the ethnic mortality ratio were examined as well as other covariates such as biochemical parameters, hemodynamic variables, and anthropometric variables such as socioeconomic status, health care access and utilization and migrant status. A sample of 200 Mexican-American and 200 non-Hispanic white death certificates were verified by medical record review. The purpose of the review was to determine whether Mexican Americans, deemed to have died of cardiovascular causes based on medical record review, were more or less likely to have cardiovascular codes (ICDA 390-459) listed on their death certificates than non-Hispanic whites deemed to have died of these causes. The review aided in the interpretation of data relating to possible ethnic differences in cause-specific mortality based on death certificate coding.
The study should help to explain whether the "Hispanic paradox" is an artifact of underascertainment of deaths in this group. The "Hispanic paradox" refers to the concept that all-cause and cardiovascular (CV) mortality are widely thought to be lower in Hispanics, including Mexican Americans, than in non-Hispanic whites in the United States. Preliminary mortality data from this study suggest that all-cause mortality is actually higher in Mexican Americans than in non-Hispanic whites in San Antonio.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Myocardial Infarction, Angina Pectoris, Death, Sudden, Cardiac, Cerebrovascular Disorders
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Myocardial Infarction, Angina Pectoris, Death, Sudden, Cardiac, Cerebrovascular Disorders, Peripheral Vascular Diseases, Coronary Disease
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 startAug 1987
- Study completionJul 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (86)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 at San AntonioThe 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
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Michael Stern, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005205
- Sponsor's protocol ID
- 1084
- Other IDs
- R01HL036820
- Status last verified
- Mar 2016
- First submitted
- 25 May 2000
- Last updated
- 8 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Haffner SM, Mykkanen L, Gruber KK, Rainwater DL, Laakso M. Lack of association between sex hormones and Lp(a) concentrations in American and Finnish men. Arterioscler Thromb. 1994 Jan;14(1):19-24. doi: 10.1161/01.atv.14.1.19.
PubMed 8274474Haffner SM, Gonzales C, Valdez RA, Mykkanen L, Hazuda HP, Mitchell BD, Monterrosa A, Stern MP. Is microalbuminuria part of the prediabetic state? The Mexico City Diabetes Study. Diabetologia. 1993 Oct;36(10):1002-6. doi: 10.1007/BF02374491.
PubMed 8243847Haffner SM, Diehl AK, Valdez R, Mitchell BD, Hazuda HP, Morales P, Stern MP. Clinical gallbladder disease in NIDDM subjects. Relationship to duration of diabetes and severity of glycemia. Diabetes Care. 1993 Sep;16(9):1276-84. doi: 10.2337/diacare.16.9.1276.
PubMed 8404432Stern MP, Valdez RA, Haffner SM, Mitchell BD, Hazuda HP. Stability over time of modern diagnostic criteria for type II diabetes. Diabetes Care. 1993 Jul;16(7):978-83. doi: 10.2337/diacare.16.7.978.
PubMed 8359106Haffner SM, Mykkanen L, Stern MP, Valdez RA, Heisserman JA, Bowsher RR. Relationship of proinsulin and insulin to cardiovascular risk factors in nondiabetic subjects. Diabetes. 1993 Sep;42(9):1297-302. doi: 10.2337/diab.42.9.1297.
PubMed 8349041Stern MP, Morales PA, Valdez RA, Monterrosa A, Haffner SM, Mitchell BD, Hazuda HP. Predicting diabetes. Moving beyond impaired glucose tolerance. Diabetes. 1993 May;42(5):706-14. doi: 10.2337/diab.42.5.706.
PubMed 8482427Haffner SM, Morales PA, Gruber MK, Hazuda HP, Stern MP. Cardiovascular risk factors in non-insulin-dependent diabetic subjects with microalbuminuria. Arterioscler Thromb. 1993 Feb;13(2):205-10. doi: 10.1161/01.atv.13.2.205.
PubMed 8427856Morales PA, Mitchell BD, Valdez RA, Hazuda HP, Stern MP, Haffner SM. Incidence of NIDDM and impaired glucose tolerance in hypertensive subjects. The San Antonio Heart Study. Diabetes. 1993 Jan;42(1):154-61. doi: 10.2337/diab.42.1.154.
PubMed 8420812Haffner SM, Morales PA, Hazuda HP, Stern MP. Level of control of hypertension in Mexican Americans and non-Hispanic whites. Hypertension. 1993 Jan;21(1):83-8. doi: 10.1161/01.hyp.21.1.83.
PubMed 8418027Haffner SM, Miettinen H, Stern MP. Relatively more atherogenic coronary heart disease risk factors in prediabetic women than in prediabetic men. Diabetologia. 1997 Jun;40(6):711-7. doi: 10.1007/s001250050738.
PubMed 9222652Haffner SM, Miettinen H, Stern MP. Are risk factors for conversion to NIDDM similar in high and low risk populations? Diabetologia. 1997 Jan;40(1):62-6. doi: 10.1007/s001250050643.
PubMed 9028719Wei M, Stern MP, Haffner SM. Serum leptin levels in Mexican Americans and non-Hispanic whites: association with body mass index and cigarette smoking. Ann Epidemiol. 1997 Feb;7(2):81-6. doi: 10.1016/s1047-2797(96)00114-7.
PubMed 9099395Wei M, Gaskill SP, Haffner SM, Stern MP. Waist circumference as the best predictor of noninsulin dependent diabetes mellitus (NIDDM) compared to body mass index, waist/hip ratio and other anthropometric measurements in Mexican Americans--a 7-year prospective study. Obes Res. 1997 Jan;5(1):16-23. doi: 10.1002/j.1550-8528.1997.tb00278.x.
PubMed 9061711Haffner SM, Miettinen H, Gaskill SP, Stern MP. Decreased insulin action and insulin secretion predict the development of impaired glucose tolerance. Diabetologia. 1996 Oct;39(10):1201-7. doi: 10.1007/BF02658507.
PubMed 8897008Wei M, Valdez RA, Mitchell BD, Haffner SM, Stern MP, Hazuda HP. Migration status, socioeconomic status, and mortality rates in Mexican Americans and non-Hispanic whites: the San Antonio Heart Study. Ann Epidemiol. 1996 Jul;6(4):307-13. doi: 10.1016/s1047-2797(96)00026-9.
PubMed 8876841
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Diabetes and Cardiovascular Disease in Mexican Americans
- ClinicalTrials.gov ID
- NCT00005205
- Acronym / sponsor ID
- 1084
- Conditions
- Cardiovascular Diseases, Heart Diseases, Myocardial Infarction, Angina Pectoris, Death, Sudden, Cardiac, Cerebrovascular Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Aug 1987
- Study completion
- Jul 2003
- 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 determine the incidence of type II diabetes and cardiovascular disease among Mexican-American and non-Hispanic whites in a 15 to 24 year follow-up of the San Antonio Heart Study 1 participants. Also, to perform a 15 to 24 year mortality follow-up of the cohort and to examine the "Hispanic paradox".
Detailed description
BACKGROUND:
The San Antonio Heart Study 1 was a population-based survey of diabetes and cardiovascular risk factors in Mexican Americans and non-Hispanic whites conducted from 1979 to 1982. Participants included all men and non-pregnant women ages 24 to 64, who resided in households randomly sampled from three socio-culturally distinct neighborhoods of San Antonio. The low-income barrio residents were almost exclusively traditional Mexican-Americans. The middle-income neighborhood was ethnically balanced with equal numbers of Mexican Americans and Anglos whereas the upper income suburb was approximately 90 percent Anglo. Risk factors measured included obesity, glucose intolerance, hypertriglyceridemia, low levels of high density lipoprotein cholesterol, and blood pressure. The total number of people who were examined medically was 2,386, divided as follows: 1,288 Mexican Americans; 929 Anglos; and 169 other Hispanics such as Cubans. The San Antonio Heart Study 1 was designed to test the hypothesis that as Mexican Americans became progressively more affluent and accultured to mainstream United States culture, they would gradually lose their diabetic pattern of cardiovascular risk factors of obesity, diabetes, and hypertriglyceridemia.
Mexican Americans are the second largest minority group in the United States. Despite this, as recently as 1977, little was known about their health status. In recent years this situation has begun to change with publication of results from several major studies including the San Antonio Heart Study, the Starr County Study, and most recently the Hispanic Health and Nutrition Examination Survey (HHANES).
DESIGN NARRATIVE:
Beginning in 1987, each participant in the prospective San Antonio Heart Study 1 was recalled as close as possible to the eighth anniversary of his or her baseline examination and re-examined. Subjects had fasting lipid and lipoprotein determinations, a glucose tolerance test to diagnose incident cases of non-insulin dependent diabetes mellitus according to the National Diabetes Data Group criteria, blood pressure measurements, a resting electrocardiogram, and completed a questionnaire to elicit information on possible cardiovascular endpoints. Medical records were obtained to document the endpoints. Subjects with a history of peripheral vascular disease or diabetes had ankle/arm blood pressure ratios determined before and after exercise. Deaths were ascertained in the course of routine follow-up supplemented by search of state health department and National Death Index records. Death certificates were requested and for those certificates indicating diabetes or cardiovascular disease as the cause of death, hospital or physician records were requested and reviewed. Standardized criteria were used to validate cause of death. Endpoints included diabetes, sudden cardiac death, non-fatal (including silent) myocardial infarction, angina pectoris, cerebrovascular and peripheral vascular disease. The study was renewed in 1992 to continue follow-up.
The study was renewed in 1998 to perform a 15 to 24 year mortality follow-up of the cohort. Time dependencies in the ethnic mortality ratio were examined as well as other covariates such as biochemical parameters, hemodynamic variables, and anthropometric variables such as socioeconomic status, health care access and utilization and migrant status. A sample of 200 Mexican-American and 200 non-Hispanic white death certificates were verified by medical record review. The purpose of the review was to determine whether Mexican Americans, deemed to have died of cardiovascular causes based on medical record review, were more or less likely to have cardiovascular codes (ICDA 390-459) listed on their death certificates than non-Hispanic whites deemed to have died of these causes. The review aided in the interpretation of data relating to possible ethnic differences in cause-specific mortality based on death certificate coding.
The study should help to explain whether the "Hispanic paradox" is an artifact of underascertainment of deaths in this group. The "Hispanic paradox" refers to the concept that all-cause and cardiovascular (CV) mortality are widely thought to be lower in Hispanics, including Mexican Americans, than in non-Hispanic whites in the United States. Preliminary mortality data from this study suggest that all-cause mortality is actually higher in Mexican Americans than in non-Hispanic whites in San Antonio.
Study design
Who may qualify
- Ages
- 24 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 8 Mar 2016.
- Background: PubMed 8274474Haffner SM, Mykkanen L, Gruber KK, Rainwater DL, Laakso M. Lack of association between sex hormones and Lp(a) concentrations in American and Finnish men. Arterioscler Thromb. 1994 Jan;14(1):19-24. doi: 10.1161/01.atv.14.1.19.
- Background: PubMed 8243847Haffner SM, Gonzales C, Valdez RA, Mykkanen L, Hazuda HP, Mitchell BD, Monterrosa A, Stern MP. Is microalbuminuria part of the prediabetic state? The Mexico City Diabetes Study. Diabetologia. 1993 Oct;36(10):1002-6. doi: 10.1007/BF02374491.
- Background: PubMed 8404432Haffner SM, Diehl AK, Valdez R, Mitchell BD, Hazuda HP, Morales P, Stern MP. Clinical gallbladder disease in NIDDM subjects. Relationship to duration of diabetes and severity of glycemia. Diabetes Care. 1993 Sep;16(9):1276-84. doi: 10.2337/diacare.16.9.1276.
- Background: PubMed 8359106Stern MP, Valdez RA, Haffner SM, Mitchell BD, Hazuda HP. Stability over time of modern diagnostic criteria for type II diabetes. Diabetes Care. 1993 Jul;16(7):978-83. doi: 10.2337/diacare.16.7.978.
- Background: PubMed 8349041Haffner SM, Mykkanen L, Stern MP, Valdez RA, Heisserman JA, Bowsher RR. Relationship of proinsulin and insulin to cardiovascular risk factors in nondiabetic subjects. Diabetes. 1993 Sep;42(9):1297-302. doi: 10.2337/diab.42.9.1297.
- Background: PubMed 8482427Stern MP, Morales PA, Valdez RA, Monterrosa A, Haffner SM, Mitchell BD, Hazuda HP. Predicting diabetes. Moving beyond impaired glucose tolerance. Diabetes. 1993 May;42(5):706-14. doi: 10.2337/diab.42.5.706.
- Background: PubMed 8427856Haffner SM, Morales PA, Gruber MK, Hazuda HP, Stern MP. Cardiovascular risk factors in non-insulin-dependent diabetic subjects with microalbuminuria. Arterioscler Thromb. 1993 Feb;13(2):205-10. doi: 10.1161/01.atv.13.2.205.
- Background: PubMed 8420812Morales PA, Mitchell BD, Valdez RA, Hazuda HP, Stern MP, Haffner SM. Incidence of NIDDM and impaired glucose tolerance in hypertensive subjects. The San Antonio Heart Study. Diabetes. 1993 Jan;42(1):154-61. doi: 10.2337/diab.42.1.154.
- Background: PubMed 8418027Haffner SM, Morales PA, Hazuda HP, Stern MP. Level of control of hypertension in Mexican Americans and non-Hispanic whites. Hypertension. 1993 Jan;21(1):83-8. doi: 10.1161/01.hyp.21.1.83.
- Background: PubMed 9222652Haffner SM, Miettinen H, Stern MP. Relatively more atherogenic coronary heart disease risk factors in prediabetic women than in prediabetic men. Diabetologia. 1997 Jun;40(6):711-7. doi: 10.1007/s001250050738.
- Background: PubMed 9028719Haffner SM, Miettinen H, Stern MP. Are risk factors for conversion to NIDDM similar in high and low risk populations? Diabetologia. 1997 Jan;40(1):62-6. doi: 10.1007/s001250050643.
- Background: PubMed 9099395Wei M, Stern MP, Haffner SM. Serum leptin levels in Mexican Americans and non-Hispanic whites: association with body mass index and cigarette smoking. Ann Epidemiol. 1997 Feb;7(2):81-6. doi: 10.1016/s1047-2797(96)00114-7.
- Individual participant dataSharing planned: No
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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.
Michael Stern principal investigator
University of Texas
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, run by The University of Texas Health Science Center at San Antonio.
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 8 Mar 2016. 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 NCT00005205, which also lists 86 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 8 Mar 2016.