Clinical trial NCT00005205: Incidence of Diabetes and Cardiovascular Disease in Mexican Americans
Official title: Incidence of Diabetes and Cardiovascular Disease in Mexican Americans
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Heart Diseases
Myocardial Infarction
Angina Pectoris
Death, Sudden, Cardiac
Cerebrovascular Disorders
Peripheral Vascular Diseases
Coronary Disease
Diabetes Mellitus, Non-insulin Dependent
Diabetes Mellitus
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2000-05-26
Sex: ALL
Minimum age (years): 24
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no

Brief 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".

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.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Texas
name: Michael Stern
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Pugh JA, Tuley MR, Hazuda HP, Stern MP. The influence of outpatient insurance coverage on the microvascular complications of non-insulin-dependent diabetes in Mexican Americans. J Diabetes Complications. 1992 Oct-Dec;6(4):236-41. doi: 10.1016/1056-8727(92)90058-s.
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citation: Gonzelez C, Stern MP, Mitchell BD, Valdez RA, Haffner SM, Perez BA. Clinical characteristics of type II diabetic subjects consuming high versus low carbohydrate diets in Mexico City and San Antonio, Texas. Diabetes Care. 1994 May;17(5):397-404. doi: 10.2337/diacare.17.5.397.
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citation: Gonzalez-Villalpando C, Stern MP, Haffner SM, Gonzalez Villapando ME, Gaskill S, Rivera Martinez D. Prevalence of hypertension in a Mexican population according to the Sixth Report of the Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure. J Cardiovasc Risk. 1999 Jun;6(3):177-81. doi: 10.1177/204748739900600309.
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citation: Wei M, Gibbons LW, Mitchell TL, Kampert JB, Stern MP, Blair SN. Low fasting plasma glucose level as a predictor of cardiovascular disease and all-cause mortality. Circulation. 2000 May 2;101(17):2047-52. doi: 10.1161/01.cir.101.17.2047.
citation: Haffner SM, Mykkanen L, Festa A, Burke JP, Stern MP. Insulin-resistant prediabetic subjects have more atherogenic risk factors than insulin-sensitive prediabetic subjects: implications for preventing coronary heart disease during the prediabetic state. Circulation. 2000 Mar 7;101(9):975-80. doi: 10.1161/01.cir.101.9.975.
citation: Lorenzo C, Serrano-Rios M, Martinez-Larrad MT, Gabriel R, Williams K, Gonzalez-Villalpando C, Stern MP, Hazuda HP, Haffner S. Prevalence of hypertension in Hispanic and non-Hispanic white populations. Hypertension. 2002 Feb;39(2):203-8. doi: 10.1161/hy0202.103439.
citation: del Rincon ID, Williams K, Stern MP, Freeman GL, Escalante A. High incidence of cardiovascular events in a rheumatoid arthritis cohort not explained by traditional cardiac risk factors. Arthritis Rheum. 2001 Dec;44(12):2737-45. doi: 10.1002/1529-0131(200112)44:123.0.CO;2-%23.
citation: Lorenzo C, Serrano-Rios M, Martinez-Larrad MT, Gabriel R, Williams K, Gonzalez-Villalpando C, Stern MP, Hazuda HP, Haffner SM. Was the historic contribution of Spain to the Mexican gene pool partially responsible for the higher prevalence of type 2 diabetes in mexican-origin populations? The Spanish Insulin Resistance Study Group, the San Antonio Heart Study, and the Mexico City Diabetes Study. Diabetes Care. 2001 Dec;24(12):2059-64. doi: 10.2337/diacare.24.12.2059.
citation: Burke JP, Williams K, Haffner SM, Villalpando CG, Stern MP. Elevated incidence of type 2 diabetes in San Antonio, Texas, compared with that of Mexico City, Mexico. Diabetes Care. 2001 Sep;24(9):1573-8. doi: 10.2337/diacare.24.9.1573.
citation: Burke JP, Hazuda HP, Stern MP. Rising trend in obesity in Mexican Americans and non-Hispanic whites: is it due to cigarette smoking cessation? Int J Obes Relat Metab Disord. 2000 Dec;24(12):1689-94. doi: 10.1038/sj.ijo.0801439.
citation: Stern MP, Williams K, Haffner SM. Identification of persons at high risk for type 2 diabetes mellitus: do we need the oral glucose tolerance test? Ann Intern Med. 2002 Apr 16;136(8):575-81. doi: 10.7326/0003-4819-136-8-200204160-00006.
citation: Stern MP, Fatehi P, Williams K, Haffner SM. Predicting future cardiovascular disease: do we need the oral glucose tolerance test? Diabetes Care. 2002 Oct;25(10):1851-6. doi: 10.2337/diacare.25.10.1851.
citation: Hunt KJ, Williams K, Resendez RG, Hazuda HP, Haffner SM, Stern MP. All-cause and cardiovascular mortality among diabetic participants in the San Antonio Heart Study: evidence against the "Hispanic Paradox". Diabetes Care. 2002 Sep;25(9):1557-63. doi: 10.2337/diacare.25.9.1557.
citation: Lorenzo C, Serrano-Rios M, Martinez-Larrad MT, Gabriel R, Williams K, Gomez-Gerique JA, Stern MP, Haffner SM. Central adiposity determines prevalence differences of the metabolic syndrome. Obes Res. 2003 Dec;11(12):1480-7. doi: 10.1038/oby.2003.198.
citation: Ferrannini E, Nannipieri M, Williams K, Gonzales C, Haffner SM, Stern MP. Mode of onset of type 2 diabetes from normal or impaired glucose tolerance. Diabetes. 2004 Jan;53(1):160-5. doi: 10.2337/diabetes.53.1.160.
citation: Hunt KJ, Resendez RG, Williams K, Haffner SM, Stern MP, Hazuda HP. All-cause and cardiovascular mortality among Mexican-American and non-Hispanic White older participants in the San Antonio Heart Study- evidence against the "Hispanic paradox". Am J Epidemiol. 2003 Dec 1;158(11):1048-57. doi: 10.1093/aje/kwg249.
citation: Del Rincon I, Williams K, Stern MP, Freeman GL, O'Leary DH, Escalante A. Association between carotid atherosclerosis and markers of inflammation in rheumatoid arthritis patients and healthy subjects. Arthritis Rheum. 2003 Jul;48(7):1833-40. doi: 10.1002/art.11078.
citation: Lorenzo C, Okoloise M, Williams K, Stern MP, Haffner SM; San Antonio Heart Study. The metabolic syndrome as predictor of type 2 diabetes: the San Antonio heart study. Diabetes Care. 2003 Nov;26(11):3153-9. doi: 10.2337/diacare.26.11.3153.
citation: Burke JP, Williams K, Narayan KM, Leibson C, Haffner SM, Stern MP. A population perspective on diabetes prevention: whom should we target for preventing weight gain? Diabetes Care. 2003 Jul;26(7):1999-2004. doi: 10.2337/diacare.26.7.1999.
citation: Hanley AJ, Williams K, Gonzalez C, D'Agostino RB Jr, Wagenknecht LE, Stern MP, Haffner SM; San Antonio Heart Study; Mexico City Diabetes Study; Insulin Resistance Atherosclerosis Study. Prediction of type 2 diabetes using simple measures of insulin resistance: combined results from the San Antonio Heart Study, the Mexico City Diabetes Study, and the Insulin Resistance Atherosclerosis Study. Diabetes. 2003 Feb;52(2):463-9. doi: 10.2337/diabetes.52.2.463.
citation: Meigs JB, Williams K, Sullivan LM, Hunt KJ, Haffner SM, Stern MP, Gonzalez Villalpando C, Perhanidis JS, Nathan DM, D'Agostino RB Jr, D'Agostino RB Sr, Wilson PW. Using metabolic syndrome traits for efficient detection of impaired glucose tolerance. Diabetes Care. 2004 Jun;27(6):1417-26. doi: 10.2337/diacare.27.6.1417.
citation: Stern MP, Williams K, Gonzalez-Villalpando C, Hunt KJ, Haffner SM. Does the metabolic syndrome improve identification of individuals at risk of type 2 diabetes and/or cardiovascular disease? Diabetes Care. 2004 Nov;27(11):2676-81. doi: 10.2337/diacare.27.11.2676.
citation: Hunt KJ, Resendez RG, Williams K, Haffner SM, Stern MP; San Antonio Heart Study. National Cholesterol Education Program versus World Health Organization metabolic syndrome in relation to all-cause and cardiovascular mortality in the San Antonio Heart Study. Circulation. 2004 Sep 7;110(10):1251-7. doi: 10.1161/01.CIR.0000140762.04598.F9. Epub 2004 Aug 23.