CARDIOVASCULAR DISEASE AND DIABETIC NEPHROPATHY

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。少数民族2型糖尿病的患病率明显更高，这些人更容易从2型糖尿病中获得并发症，包括肾脏疾病。患有肾脏疾病的人更容易患心脏病；墨西哥裔美国人患2型糖尿病和肾病的风险概况和疾病负担从未明确。该研究是一项前瞻性、观察性、队列研究，研究对象为墨西哥裔美国人和非西班牙裔白人糖尿病肾病患者。本研究的目的是确定患有糖尿病肾病的墨西哥裔美国人队列的基线动脉粥样硬化负担（通过冠状动脉钙化来评估）、动脉粥样硬化负担的进展速度、总死亡率和心血管死亡率，并将其与患有糖尿病肾病的非西班牙裔白人队列进行比较。此外，将研究几种动脉粥样硬化危险因素对解释冠状动脉钙化负担的种族差异的贡献。将研究两个新出现的因素（血浆同型半胱氨酸和血清瘦素水平）以及几个社会经济变量，以确定它们对冠状动脉钙化负担的种族差异的贡献。在本研究中，将招募125名墨西哥裔美国人和125名非西班牙裔白人患者，这些患者符合糖尿病肾病的临床定义，并在港-加州大学洛杉矶分校医学中心或加州大学欧文分校就诊。在基线门诊就诊时，患者将接受病史、体格检查、尿液和血液检查、营养评估、12导联心电图和电子束计算机断层扫描（EBCT）。此外，将通过对患者进行问卷调查来评估社会经济地位。这份调查表将评估家庭收入、教育水平、就业状况以及获得保健的机会。在12个月时，除EBCT扫描外，将重复进行整个评估。在24个月时，将重复临床评估和EBCT。将每隔6个月通过电话联系患者，以最大限度地提高完整随访的机会，以确定住院的需要（病态结果）以及死亡率。住院或死亡的原因将通过检查患者在港湾-加州大学洛杉矶分校医疗中心或任何其他医院的医疗记录来证实。即使在完成24个月的随访后，患者也将在整个研究期间接受随访——这意味着患者将接受不同时间长度的随访——早期登记的患者将接受最长时间的随访。最后，每位患者5 ml血清和5 ml尿液将在-70℃保存，以备将来调查。本研究为观察性研究，研究相关程序（病史、体格检查、尿液检查、静脉穿刺、EBCT）已广泛应用于人类。没有研究相关的干预措施。临床和EBCT评估的摘要将被发送给患者（并指示将评估摘要交给他们的医生）以及他们的医生（如果我们能够可靠地确定医生的姓名/地址）。这将确保根据患者参与研究时所做的测试，向患者提供适当的医疗护理。因此，参与这项研究的风险是：暴露于辐射，静脉穿刺的风险，与回答有关其社会经济地位的问题有关的不适，以及可能丧失隐私。所有有生育潜力的女性，在进行EBCT扫描之前，将进行尿液妊娠试验。这项研究的好处包括对心血管危险因素和动脉粥样硬化负担的全面评估，这些信息将传达给患者和他们的医生（如果可能的话），这可能导致适当的卫生保健干预。因此，总的来说，风险收益比有利于这项研究。

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 related 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 possible) and this may lead to appropriate health care interventions. Thus, in balance, the risk-benefit ratio favor the study.