Cardiovascular DiseasesNCT00005146
Diabetes and Cardiovascular Risk In Mexico City (San Antonio Heart Study)
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 factors beyond obesity which contribute to diabetes and cardiovascular risk in Mexicans and Mexican Americans. To test the hypothesis that at any given level of adiposity Mexican Americans will be more insulin resistant than Anglos and that the insulin resistance in Mexican Americans is proportional to… Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Diabetes Mellitus, Non-insulin Dependent
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- May 1979to Aug 2002
- 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 Up to 100 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To determine factors beyond obesity which contribute to diabetes and cardiovascular risk in Mexicans and Mexican Americans. To test the hypothesis that at any given level of adiposity Mexican Americans will be more insulin resistant than Anglos and that the insulin resistance in Mexican Americans is proportional to the degree of Native American ancestry.
Read the detailed description
BACKGROUND:
The present study was preceded by the earlier San Antonio Heart Study 1 supported under this grant. The San Antonio Heart Study 1 was a population-based survey of diabetes and cardiovascular risk factors in Mexican American 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 was designed to test the hypothesis that as Mexican Americans became progressively more affluent and acculturated to 'mainstream' United States culture, they would gradually lose their diabetic pattern of cardiovascular risk factors of obesity, diabetes, and hypertriglyceridemia.
DESIGN NARRATIVE:
Beginning in 1979, a random sample was conducted to select participants. Sampling was performed to match the two groups on obesity, thereby enabling an analysis of the ethnic differences in diabetes and cardiovascular risk factors independent of the confounding effects of obesity. For those selected, an interview and medical examination were conducted in a mobile clinic. The interview consisted of a personal and family history of diabetes and cardiovascular risk, knowledge of and attitudes towards cardiovascular risk factors, dietary questionnaire, Rose Angina questionnaire, intermittent claudication questionnaire, and medication history. The medical examination consisted of anthropometric measurements, plasma glucose, plasma insulin, hemoglobin, serum cholesterol, triglyceride, HDL, LDL, and VLDL, genetic markers, blood pressure, skin color and electrocardiogram. It was estimated that 400 diabetics would be available over the four years of the study to permit a Diabetic Recall Examination. The purpose of the Diabetic Recall Examination was to assess possible end-organ complications of diabetes involving the eye, kidney, peripheral and autonomic nervous systems, and the peripheral vascular system. The assessment provided baseline data on diabetics which was used for a prospective incidence study. Beginning in 1989, a prevalence survey of type II diabetes mellitus and cardiovascular risk factors was conducted in a low-income barrio in Mexico City. Information collected on this population included demographic data, socioeconomic status, level of acculturation, medical history, diet, exercise, and smoking. The physical examination included measurements of blood pressure, obesity, body fat distribution, and skin color. The laboratory examination included measurements of lipids and lipoproteins, oral glucose tolerance tests, fasting and post-glucose load insulin concentrations and genetic markers.
Beginning in FY 1989, Michael Stern and associates carried out an epidemiologic study of type II diabetes mellitus and cardiovascular risk factors in a low-income barrio of Mexico City and compared results to those obtained in San Antonio. They recruited and interviewed subjects for data on demographics, socioeconomic status, level of acculturation, medical history, health habits including diet, physical exercise, and smoking. The physical examination included blood pressure, obesity, body fat distribution, skin color, the latter to estimate percent Native American genetic admixture. The laboratory examination included measurements of lipids and lipoproteins, an oral glucose tolerance test to determine the prevalence of diabetes according to the National Diabetes Data Group criteria, fasting and post-glucose load insulin concentrations, and genetic markers.
The study was renewed in 1996 through August, 2001. A 3.25 year followup examination (FU1) of a cohort of 2,296 Mexican men and women, ages 35-64 years at baseline, was completed. The cohort was re-examined at 3.25-year intervals (6.5 years (FU2) and 9.75 years (FU3) after baseline). The investigators tested the hypothesis that different risk factors would prevail in the early (more than 3.25 years prior to conversion to diabetes) than in the late (3.25 years or less prior to conversion) prediabetic period. They hypothesized that in the early prediabetic period risk factors associated with the Insulin Resistance Syndrome would predominate, i.e., high "specific" insulin concentration (measured by a specific immunoassay), hypertriglyceridemia, low HDL-cholesterol, and hypertension, whereas in the late prediabetic period factors associated with insulin secretory failure, i.e., increased proinsulin and low "specific" insulin, would predominate.
Michael Stern and associates assessed carotid wall thickness by ultrasonography on all subjects at FU1 and planned to repeat this at FU2. They measured advanced glycation endproduct (AGE)-modified apolipoprotein B and a panel of inflammatory risk factors (serum albumin, serum amyloid A, alpha1-acid glycoprotein, and C-reactive protein) on stored contingency specimens from baseline and FU1 in order to determine if these factors predicted accelerated thickening of carotid walls and/or the development of type II diabetes. They also quantified the extent to which carotid wall thickness and ECG documented myocardial infarction preceded clinical diabetes as predicted by the "common soil" hypothesis, i.e., the hypothesis that both type II diabetes and atherosclerosis have common genetic and environmental antecedents.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Diabetes Mellitus, Non-insulin Dependent, Diabetes Mellitus
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Diabetes Mellitus, Type 2, Diabetes Mellitus
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 startMay 1979
- Study completionAug 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (182)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, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005146
- Sponsor's protocol ID
- 1017
- Other IDs
- R01HL024799
- 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
Stern MP, Pugh JA, Gaskill SP, Hazuda HP. Knowledge, attitudes, and behavior related to obesity and dieting in Mexican Americans and Anglos: the San Antonio Heart Study. Am J Epidemiol. 1982 Jun;115(6):917-28. doi: 10.1093/oxfordjournals.aje.a113379.
PubMed 7091149Stern MP, Gaskill SP, Hazuda HP, Gardner LI, Haffner SM. Does obesity explain excess prevalence of diabetes among Mexican Americans? Results of the San Antonio Heart Study. Diabetologia. 1983 Apr;24(4):272-7. doi: 10.1007/BF00282712.
PubMed 6862133Malina RM, Little BB, Stern MP, Gaskill SP, Hazuda HP. Ethnic and social class differences in selected anthropometric characteristics of Mexican American and Anglo adults: the San Antonio Heart Study. Hum Biol. 1983 Dec;55(4):867-83. No abstract available.
PubMed 6674108Relethford JH, Stern MP, Gaskill SP, Hazuda HP. Social class, admixture, and skin color variation in Mexican-Americans and Anglo-Americans living in San Antonio, Texas. Am J Phys Anthropol. 1983 May;61(1):97-102. doi: 10.1002/ajpa.1330610110.
PubMed 6869517Hazuda HP, Stern MP, Gaskill SP, Haffner SM, Gardner LI. Ethnic differences in health knowledge and behaviors related to the prevention and treatment of coronary heart disease. The San Antonio Heart Study. Am J Epidemiol. 1983 Jun;117(6):717-28. doi: 10.1093/aje/117.6.717.
PubMed 6859027Haffner SM, Rosenthal M, Hazuda HP, Stern MP, Franco LJ. Evaluation of three potential screening tests for diabetes mellitus in a biethnic population. Diabetes Care. 1984 Jul-Aug;7(4):347-53. doi: 10.2337/diacare.7.4.347.
PubMed 6468231Gardner LI Jr, Stern MP, Haffner SM, Gaskill SP, Hazuda HP, Relethford JH, Eifler CW. Prevalence of diabetes in Mexican Americans. Relationship to percent of gene pool derived from native American sources. Diabetes. 1984 Jan;33(1):86-92. doi: 10.2337/diab.33.1.86.
PubMed 6690348Stern MP, Rosenthal M, Haffner SM, Hazuda HP, Franco LJ. Sex difference in the effects of sociocultural status on diabetes and cardiovascular risk factors in Mexican Americans. The San Antonio Heart Study. Am J Epidemiol. 1984 Dec;120(6):834-51. doi: 10.1093/oxfordjournals.aje.a113956.
PubMed 6507426Deyo RA, Diehl AK, Hazuda H, Stern MP. A simple language-based acculturation scale for Mexican Americans: validation and application to health care research. Am J Public Health. 1985 Jan;75(1):51-5. doi: 10.2105/ajph.75.1.51.
PubMed 3966599Rosenthal M, McMahan CA, Stern MP, Eifler CW, Haffner SM, Hazuda HP, Franco LJ. Evidence of bimodality of two hour plasma glucose concentrations in Mexican Americans: results from the San Antonio Heart study. J Chronic Dis. 1985;38(1):5-16. doi: 10.1016/0021-9681(85)90003-7.
PubMed 3972950Haffner SM, Knapp JA, Stern MP, Hazuda HP, Rosenthal M, Franco LJ. Coffee consumption, diet, and lipids. Am J Epidemiol. 1985 Jul;122(1):1-12. doi: 10.1093/oxfordjournals.aje.a114067.
PubMed 4014187Franco LJ, Stern MP, Rosenthal M, Haffner SM, Hazuda HP, Comeaux PJ. Prevalence, detection, and control of hypertension in a biethnic community. The San Antonio Heart Study. Am J Epidemiol. 1985 May;121(5):684-96. doi: 10.1093/aje/121.5.684.
PubMed 4014160Knapp JA, Haffner SM, Young EA, Hazuda HP, Gardner L, Stern MP. Dietary intakes of essential nutrients among Mexican-Americans and Anglo-Americans: the San Antonio Heart Study. Am J Clin Nutr. 1985 Aug;42(2):307-16. doi: 10.1093/ajcn/42.2.307.
PubMed 4025200Stern MP: Diabetes in Hispanic Americans. In: Diabetes in America Harris MI, Hamman R (Eds). U.S. Government Printing Office, NIH Publication No. 85-1468, Washington DC, pp IX-1-11, Aug 1985
Stern MP, Rosenthal M, Haffner SM. A new concept of impaired glucose tolerance. Relation to cardiovascular risk. Arteriosclerosis. 1985 Jul-Aug;5(4):311-4. doi: 10.1161/01.atv.5.4.311. No abstract available.
PubMed 4015505
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
- Diabetes and Cardiovascular Risk In Mexico City (San Antonio Heart Study)
- ClinicalTrials.gov ID
- NCT00005146
- Acronym / sponsor ID
- 1017
- Conditions
- Cardiovascular Diseases, Heart Diseases, Diabetes Mellitus, Non-insulin Dependent, Diabetes Mellitus
- 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
- May 1979
- Study completion
- Aug 2002 (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 determine factors beyond obesity which contribute to diabetes and cardiovascular risk in Mexicans and Mexican Americans. To test the hypothesis that at any given level of adiposity Mexican Americans will be more insulin resistant than Anglos and that the insulin resistance in Mexican Americans is proportional to the degree of Native American ancestry.
Detailed description
BACKGROUND:
The present study was preceded by the earlier San Antonio Heart Study 1 supported under this grant. The San Antonio Heart Study 1 was a population-based survey of diabetes and cardiovascular risk factors in Mexican American 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 was designed to test the hypothesis that as Mexican Americans became progressively more affluent and acculturated to 'mainstream' United States culture, they would gradually lose their diabetic pattern of cardiovascular risk factors of obesity, diabetes, and hypertriglyceridemia.
DESIGN NARRATIVE:
Beginning in 1979, a random sample was conducted to select participants. Sampling was performed to match the two groups on obesity, thereby enabling an analysis of the ethnic differences in diabetes and cardiovascular risk factors independent of the confounding effects of obesity. For those selected, an interview and medical examination were conducted in a mobile clinic. The interview consisted of a personal and family history of diabetes and cardiovascular risk, knowledge of and attitudes towards cardiovascular risk factors, dietary questionnaire, Rose Angina questionnaire, intermittent claudication questionnaire, and medication history. The medical examination consisted of anthropometric measurements, plasma glucose, plasma insulin, hemoglobin, serum cholesterol, triglyceride, HDL, LDL, and VLDL, genetic markers, blood pressure, skin color and electrocardiogram. It was estimated that 400 diabetics would be available over the four years of the study to permit a Diabetic Recall Examination. The purpose of the Diabetic Recall Examination was to assess possible end-organ complications of diabetes involving the eye, kidney, peripheral and autonomic nervous systems, and the peripheral vascular system. The assessment provided baseline data on diabetics which was used for a prospective incidence study. Beginning in 1989, a prevalence survey of type II diabetes mellitus and cardiovascular risk factors was conducted in a low-income barrio in Mexico City. Information collected on this population included demographic data, socioeconomic status, level of acculturation, medical history, diet, exercise, and smoking. The physical examination included measurements of blood pressure, obesity, body fat distribution, and skin color. The laboratory examination included measurements of lipids and lipoproteins, oral glucose tolerance tests, fasting and post-glucose load insulin concentrations and genetic markers.
Beginning in FY 1989, Michael Stern and associates carried out an epidemiologic study of type II diabetes mellitus and cardiovascular risk factors in a low-income barrio of Mexico City and compared results to those obtained in San Antonio. They recruited and interviewed subjects for data on demographics, socioeconomic status, level of acculturation, medical history, health habits including diet, physical exercise, and smoking. The physical examination included blood pressure, obesity, body fat distribution, skin color, the latter to estimate percent Native American genetic admixture. The laboratory examination included measurements of lipids and lipoproteins, an oral glucose tolerance test to determine the prevalence of diabetes according to the National Diabetes Data Group criteria, fasting and post-glucose load insulin concentrations, and genetic markers.
The study was renewed in 1996 through August, 2001. A 3.25 year followup examination (FU1) of a cohort of 2,296 Mexican men and women, ages 35-64 years at baseline, was completed. The cohort was re-examined at 3.25-year intervals (6.5 years (FU2) and 9.75 years (FU3) after baseline). The investigators tested the hypothesis that different risk factors would prevail in the early (more than 3.25 years prior to conversion to diabetes) than in the late (3.25 years or less prior to conversion) prediabetic period. They hypothesized that in the early prediabetic period risk factors associated with the Insulin Resistance Syndrome would predominate, i.e., high "specific" insulin concentration (measured by a specific immunoassay), hypertriglyceridemia, low HDL-cholesterol, and hypertension, whereas in the late prediabetic period factors associated with insulin secretory failure, i.e., increased proinsulin and low "specific" insulin, would predominate.
Michael Stern and associates assessed carotid wall thickness by ultrasonography on all subjects at FU1 and planned to repeat this at FU2. They measured advanced glycation endproduct (AGE)-modified apolipoprotein B and a panel of inflammatory risk factors (serum albumin, serum amyloid A, alpha1-acid glycoprotein, and C-reactive protein) on stored contingency specimens from baseline and FU1 in order to determine if these factors predicted accelerated thickening of carotid walls and/or the development of type II diabetes. They also quantified the extent to which carotid wall thickness and ECG documented myocardial infarction preceded clinical diabetes as predicted by the "common soil" hypothesis, i.e., the hypothesis that both type II diabetes and atherosclerosis have common genetic and environmental antecedents.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older 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 7091149Stern MP, Pugh JA, Gaskill SP, Hazuda HP. Knowledge, attitudes, and behavior related to obesity and dieting in Mexican Americans and Anglos: the San Antonio Heart Study. Am J Epidemiol. 1982 Jun;115(6):917-28. doi: 10.1093/oxfordjournals.aje.a113379.
- Background: PubMed 6862133Stern MP, Gaskill SP, Hazuda HP, Gardner LI, Haffner SM. Does obesity explain excess prevalence of diabetes among Mexican Americans? Results of the San Antonio Heart Study. Diabetologia. 1983 Apr;24(4):272-7. doi: 10.1007/BF00282712.
- Background: PubMed 6674108Malina RM, Little BB, Stern MP, Gaskill SP, Hazuda HP. Ethnic and social class differences in selected anthropometric characteristics of Mexican American and Anglo adults: the San Antonio Heart Study. Hum Biol. 1983 Dec;55(4):867-83. No abstract available.
- Background: PubMed 6869517Relethford JH, Stern MP, Gaskill SP, Hazuda HP. Social class, admixture, and skin color variation in Mexican-Americans and Anglo-Americans living in San Antonio, Texas. Am J Phys Anthropol. 1983 May;61(1):97-102. doi: 10.1002/ajpa.1330610110.
- Background: PubMed 6859027Hazuda HP, Stern MP, Gaskill SP, Haffner SM, Gardner LI. Ethnic differences in health knowledge and behaviors related to the prevention and treatment of coronary heart disease. The San Antonio Heart Study. Am J Epidemiol. 1983 Jun;117(6):717-28. doi: 10.1093/aje/117.6.717.
- Background: PubMed 6468231Haffner SM, Rosenthal M, Hazuda HP, Stern MP, Franco LJ. Evaluation of three potential screening tests for diabetes mellitus in a biethnic population. Diabetes Care. 1984 Jul-Aug;7(4):347-53. doi: 10.2337/diacare.7.4.347.
- Background: PubMed 6690348Gardner LI Jr, Stern MP, Haffner SM, Gaskill SP, Hazuda HP, Relethford JH, Eifler CW. Prevalence of diabetes in Mexican Americans. Relationship to percent of gene pool derived from native American sources. Diabetes. 1984 Jan;33(1):86-92. doi: 10.2337/diab.33.1.86.
- Background: PubMed 6507426Stern MP, Rosenthal M, Haffner SM, Hazuda HP, Franco LJ. Sex difference in the effects of sociocultural status on diabetes and cardiovascular risk factors in Mexican Americans. The San Antonio Heart Study. Am J Epidemiol. 1984 Dec;120(6):834-51. doi: 10.1093/oxfordjournals.aje.a113956.
- Background: PubMed 3966599Deyo RA, Diehl AK, Hazuda H, Stern MP. A simple language-based acculturation scale for Mexican Americans: validation and application to health care research. Am J Public Health. 1985 Jan;75(1):51-5. doi: 10.2105/ajph.75.1.51.
- Background: PubMed 3972950Rosenthal M, McMahan CA, Stern MP, Eifler CW, Haffner SM, Hazuda HP, Franco LJ. Evidence of bimodality of two hour plasma glucose concentrations in Mexican Americans: results from the San Antonio Heart study. J Chronic Dis. 1985;38(1):5-16. doi: 10.1016/0021-9681(85)90003-7.
- Background: PubMed 4014187Haffner SM, Knapp JA, Stern MP, Hazuda HP, Rosenthal M, Franco LJ. Coffee consumption, diet, and lipids. Am J Epidemiol. 1985 Jul;122(1):1-12. doi: 10.1093/oxfordjournals.aje.a114067.
- Background: PubMed 4014160Franco LJ, Stern MP, Rosenthal M, Haffner SM, Hazuda HP, Comeaux PJ. Prevalence, detection, and control of hypertension in a biethnic community. The San Antonio Heart Study. Am J Epidemiol. 1985 May;121(5):684-96. doi: 10.1093/aje/121.5.684.
- 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
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 NCT00005146, which also lists 182 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.