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.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 在少数民族中，2型糖尿病的患病率明显更高，这些人可能会从2型糖尿病（包括肾脏疾病）中获得并发症。患有肾脏疾病的人更可能患有心脏病。墨西哥裔美国人患有2型糖尿病和肾脏疾病的风险特征以及疾病负担从未定义。 这项研究是对墨西哥裔美国人和非西班牙裔白人患有糖尿病肾病的前瞻性，观察性的，同类的研究。这项研究的目的是定义基线动脉粥样硬化负担（通过冠状动脉钙化评估），动脉粥样硬化负担的进展率以及墨西哥裔美国人患有糖尿病性肾病的墨西哥群体中的总和心血管死亡率，并与非疾病症的同胞相比，并与之相比。此外，将研究动脉粥样硬化的几个危险因素的贡献，以解释冠状动脉钙化负担的种族差异。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种族差异的贡献。 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，这些患者符合糖尿病性肾病的临床定义，并将招募在Harbour-UCLA医学中心或加利福尼亚大学 - IRVINE分校的诊所。在基线诊所就诊时，患者将接受病史，体格检查，尿液和血液检查，营养评估，12铅心电图和电子束计算机断层扫描（EBCT）。此外，通过向患者进行问卷调查来评估社会经济状况。该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机会。在12个月时，将重复整个评估，除EBCT扫描外。在24个月时，将重复临床评估以及EBCT。将通过电话以6个月的间隔与患者联系，以最大程度地进行全面随访的机会，以确定住院（病态结局）和死亡率的需求。住院或死亡的原因将通过对患者的医疗记录进行审查，无论是在港口 - 乌克萨邦医疗中心还是其他医院的审查来证实。 即使在随访的24个月后完成后，在整个研究期间都会遵循患者的遵循 - 这意味着将在可变的时间下跟踪患者 - 早期入学的患者将是最长的随访时间。最后，每个患者的5 mL血清和5 mL尿液将存储在-70oC中，以进行以后的研究。 这项研究是一项观察性研究，研究相关的程序（病史，体格检查，尿液检查，静脉穿刺和EBCT）已在人类中广泛使用。没有与研究有关的干预措施。临床和EBCT评估的摘要将发送给患者（指示将评估摘要给其医生）以及其医生（如果我们能够可靠地确定医生的名称/地址）。这将确保根据他们参与研究的一部分进行的测试，向患者提供适当的医疗服务。因此，参与研究的风险是：暴露于辐射，静脉穿刺风险，不舒服的不适，以回答有关其社会经济状况的问题以及可能失去隐私的问题。所有具有生殖潜力的妇女将在发送EBCT扫描之前进行尿液妊娠试验。这项研究的好处包括对心血管危险因素以及动脉粥样硬化负担进行全面评估 - 这些信息将与患者及其医师（如果可能的话）传达，这可能会导致适当的医疗干预措施。因此，在平衡上，风险效益比有利于这项研究。