This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The prevalence of type 2 diabetes is significantly higher in ethnic minorities and these individuals are morel likely to get complications from their type 2 diabetes, including kidney disease. Individuals with kidney disease are more likely to have heart disease;the risk profile as well as the disease burden in Mexican Americans with type 2 diabetes mellitus and kidney disease has never been defined. The study is a prospective, observational, cohort study of Mexican Americans and Non Hispanic Whites with diabetic nephropathy. The purpose of this study is to define the baseline atherosclerotic burden (as assessed by coronary artery calcification) , the rate of progression of atherosclerotic burden and the total as well as cardiovascular mortality in a cohort of Mexican Americans with diabetic nephropathy and compare it to a cohort of non-Hispanic whites with diabetic nephropathy. Furthermore, the contribution of several risk factors for atherosclerosis to explain the ethnic differences in coronary artery calcification burden will be studied. Two emerging factors (plasma homocysteine and serum leptin levels) as well as several socio-economic variables will be studied to determine their contribution to the ethnic differences in coronary artery calcification burden. For this study, 125 Mexican American and 125 Non-Hispanic White patients, that meet the clinical definition of diabetic nephropathy and attend the clinics at either Harbor-UCLA Medical Center or University of California-Irvine, will be recruited. At the baseline clinic visit, the patients will undergo a history, physical examination, urine and blood tests, nutritional assessment, 12-lead electrocardiogram and an electron beam computed tomography (EBCT). Additionally, an assessment of socio-economic status will be made by administering a questionnaire to the patient. This questionnaire will assess household income, educational level, employment status as well as access to health care. At 12 months, the entire assessment, except for the EBCT scan, will be repeated. At 24 months, the clinical assessment as well as EBCT will be repeated. The patients will be contacted via telephone at 6-month intervals to maximize chances of a complete follow-up, to determine the need for hospitalization (morbid outcomes) as well as mortality. The reason for hospitalization or death will be corroborated by a review of the patient's medical records, either at Harbor-UCLA Medical Center or at any other hospital. Even after the completion of the 24 months of followup, the patients will be followed for the entire duration of the study - this will mean that the patients will be followed for variable lengths of times - the patients that are enrolled early on will have the longest period of follow-up. Finally, 5 ml of serum and 5 ml of urine in each of the patients will be stored at -70oC for future investigations. The study is an observational study and the study related procedures (history, physical examination, urine exam, venipuncture and EBCT) have been extensively used in humans. There are no study-related interventions. A summary of the clinical as well as EBCT evaluation will be sent to the patients (with instructions to take the summary of evaluations to their physician) as well as to their physicians (if we are able to reliably determine the names/address of the physician). This will ensure that appropriate medical care is provided to the patients, based upon the tests done as a part of their participation in their study. Thus, the risks of participation in the study are: exposure to radiation, risk of venipuncture, discomfort realted to answering questions regarding their socio-economic status and possible loss of privacy. All women with reproductive potential, will undergo a urine pregnancy test before being sent for EBCT scan. The benefits of the study include a comprehensive evaluation of cardiovascular risk factors as well as atherosclerotic burden - this information will be communicated to the patients as well as their physician (if possilble) and this may lead to appropriate health care interventions. Thus, in balance, the risk-benefit ratio favor the study.

National Institute of Health (NIH)
National Center for Research Resources (NCRR)
General Clinical Research Centers Program (M01)
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Special Emphasis Panel (ZRR1-CR-5 (01))
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La Biomed Research Institute/ Harbor UCLA Medical Center
United States
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