CARDIOVASCULAR DISEASE AND DIABETIC NEPHROPATHY

心血管疾病和糖尿病肾病

• 批准号: 7952229
• 负责人: RAJNISH MEHROTRA
• 金额: $ 6.42万
• 依托单位: LUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-12-01 至 2009-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7952229
• 关键词: Address; Atherosclerosis; Blood Tests; California; Cardiovascular Diseases; Cardiovascular system; Caring; Cessation of life; Clinic; Clinic Visits; Clinical; Clinical Research; Clinical assessments; Cohort Studies; Computer Retrieval of Information on Scientific Projects Database; Diabetic Nephropathy; Economics; Educational Status; Electrocardiogram; Electron Beam Tomography; Employment Status; Enrollment; Ensure; Equilibrium; Evaluation; Exposure to; Funding; Future; Grant; Health Services Accessibility; Healthcare; Homocysteine; Homocystine; Hospitalization; Hospitals; Household; Human; Income; Individual; Institution; Instruction; Intervention; Investigation; Kidney Diseases; Lead; Length; Leptin; Medical; Medical Records; Medical center; Mexican Americans; Names; Non-Insulin-Dependent Diabetes Mellitus; Not Hispanic or Latino; Nutrition Assessment; Observational Study; Outcome; Patients; Physical Examination; Physicians; Plasma; Pregnancy Tests; Prevalence; Privacy; Procedures; Questionnaires; Radiation; Recording of previous events; Recruitment Activity; Research; Research Personnel; Resources; Risk; Risk Factors; Scanning; Serum; Socioeconomic Status; Source; Telephone; Testing; Time; United States National Institutes of Health; Universities; Urine; Venipunctures; Woman; base; burden of illness; cardiovascular risk factor; cohort; coronary artery calcification; ethnic difference; ethnic minority population; follow-up; heart disease risk; meetings; mortality; prospective; reproductive; risk benefit ratio

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.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目和 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 少数民族中 2 型糖尿病的患病率明显较高，这些人更有可能出现 2 型糖尿病并发症，包括肾脏疾病。患有肾脏疾病的人更容易患心脏病；患有 2 型糖尿病和肾病的墨西哥裔美国人的风险状况和疾病负担从未被明确过。 该研究是一项针对患有糖尿病肾病的墨西哥裔美国人和非西班牙裔白人的前瞻性、观察性队列研究。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荷（通过冠状动脉钙化评估）、动脉粥样硬化负荷的进展率以及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，还将研究动脉粥样硬化的几种危险因素对解释冠状动脉钙化负担的种族差异的贡献。将研究两个新兴因素（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影响。 在这项研究中，将招募 125 名墨西哥裔美国人和 125 名非西班牙裔白人患者，他们符合糖尿病肾病的临床定义，并在港口-加州大学洛杉矶分校医疗中心或加州大学欧文分校的诊所就诊。在基线临床访视时，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，还将通过向患者进行问卷调查来评估社会经济状况。该调查问卷将评估家庭收入、教育水平、就业状况以及获得医疗保健的情况。 12 个月时，除 EBCT 扫描外，整个评估将重复进行。 24 个月时，将重复进行临床评估和 EBCT。我们将每隔 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，以确定是否需要住院（发病结果）以及死亡率。住院或死亡的原因将通过对患者在加州大学洛杉矶分校港口医疗中心或任何其他医院的医疗记录进行审查来证实。 即使在完成 24 个月的随访后，患者仍将在整个研究期间接受随访 - 这意味着患者将接受不同长度的随访 - 早期入组的患者将获得最长的随访时间。最后，每名患者的5ml血清和5ml尿液将保存在-70℃下以备将来研究。 该研究是一项观察性研究，研究相关程序（病史、体格检查、尿液检查、静脉穿刺和 EBCT）已广泛应用于人类。没有与研究相关的干预措施。临床和 EBCT 评估的摘要将发送给患者（并附有将评估摘要交给医生的说明）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过程中进行的测试，为患者提供适当的医疗护理。因此，参与研究的风险是：暴露于辐射、静脉穿刺的风险、回答有关其社会经济地位的问题所带来的不适以及可能丧失隐私。所有具有生育潜力的女性在进行 EBCT 扫描之前都将接受尿妊娠测试。该研究的好处包括对心血管危险因素以及动脉粥样硬化负担进行全面评估——这些信息将传达给患者及其医生（如果可能），这可能会导致适当的医疗保健干预措施。因此，总的来说，风险收益比有利于这项研究。