CODA: COvid and Diabetes Assessment

CODA：新冠肺炎和糖尿病评估

基本信息

批准号：
10755899
负责人：
Jason Perry Block
金额：
$ 599.96万
依托单位：
VANDERBILT UNIVERSITY MEDICAL CENTER
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-07-21 至 2027-06-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10755899
关键词：
2019-nCoV Adult American Antibodies Area Beta Cell Biological Markers Biological Process Blood Vessels CDC42 gene COVID-19 COVID-19 diagnosis COVID-19 impact COVID-19 pandemic COVID-19 patient COVID-19 surveillance COVID-19 test COVID-19 treatment Cell physiology Cessation of life Child Childhood Childhood diabetes Clinical Clinical Research Consent Data Deterioration Development Diabetes Mellitus Diagnosis Electronic Health Record Environmental Risk Factor Epidemiology Family Fibrosis Funding Future Genomics Glucose tolerance test Health Health Services Research Health system Individual Infection Inflammation Informatics Infrastructure Insulin Resistance Insulin-Dependent Diabetes Mellitus Internet Intervention Intervention Studies Link Long COVID Metabolic Multicenter Trials Non-Insulin-Dependent Diabetes Mellitus Nucleocapsid Obesity Observational Study Outcome Outpatients Participant Patients Physiological Physiology Population Post-Acute Sequelae of SARS-CoV-2 Infection Process Public Health Records Registries Research Resources Risk Role SARS-CoV-2 exposure SARS-CoV-2 infection SARS-CoV-2 negative Serology test Site Standardization Structure Study Subject Surveys Telephone Testing Thrombophilia Time United States National Institutes of Health Work cohort community engagement coronavirus disease data hub drug repurposing electronic health data epidemiology study experience glycemic control improved member metabolomics pandemic disease patient oriented patient portal patient registry patient subsets recruit social type 2 diabetes in children type I and type II diabetes

项目摘要

Project Summary Several studies have found that infection with SARS-CoV-2 and COVID-19 diagnosis are associated with the development and progression of both Type 1 (T1D) and Type 2 Diabetes (T2D), possibly through infection of beta cells, increased insulin resistance, increased inflammation and fibrosis, and other biological processes. The proposed study will take advantage of robust existing infrastructure to rapidly identify, recruit, and retain diverse cohorts of English and Spanish speaking pediatric and adult patients with recently diagnosed T1D or T2D. The study will include 1600 study participants diagnosed with diabetes in the last 3 months, who have had a known COVID-19 infection in the past 90 days and those with recent diagnosis of diabetes and no known COVID-19 infection in the past year. The study will leverage PCORnet, a unique national network of over 60 health systems with electronic health record (EHR) data on over 80 million patients and a track record for successful study recruitment. We will query EHR records to swiftly identify potential study subjects with recent diagnosis of diabetes and contact them via patient portals, telephone, face-to-face encounters, and other approaches. We will also leverage the T1D Exchange (T1DX), a national network of 54 diabetes centers and an online patient registry of 17,000 individuals with T1D. Consented participants will partake in regular web/mobile or telephone surveys leveraging a previously developed REDCap/Twilio platform. Participants will also come to sites for regular serological testing, and a subsample will participate in more robust testing of glucose tolerance, biomarkers, and vascular function. This data will be supplemented by longitudinal EHR data from participating sites and across PCORnet. Participants will be followed for 2 years. Aim 1 will examine if patients with recent T2D who have recent COVID-19 are more likely to have worse glycemic control, increased inflammation and increased insulin resistance than patients without recent COVID-19. Aim 2 will examine if patients with recent T1D who have recent COVID-19 are more likely to have worse glycemic control, increased inflammation and more rapid reduction in beta cell function than patients without recent COVID-19. Aim 3 will evaluate a subset of patients with diabetes to examine if COVID-19 is associated with worse vascular function, increased inflammation and hypercoagulability. Aim 4 will explore the role of genomic/social/environmental factors on inflammation and metabolic function. Aim 5 will leverage EHR data to explore the role of COVID-19 and COVID-19 treatments on diabetes development and diabetes-related outcomes across the pandemic. The study will be led by a team with significant experience related to COVID-19, post-acute sequelae of COVID-19 (PASC), obesity and diabetes in children and adults, epidemiological research, informatics, health services research, genomics, metabolomics, physiology, patient and family engagement and other areas. The proposed work will provide a deeper understanding of the relationship between COVID-19 and diabetes, that can support future interventions and public health approaches to improve health.

项目摘要几项研究发现，SARS-COV-2和COVID-19诊断的感染与 1型（T1D）和2型糖尿病（T2D）的发展和进展，可能是通过感染 β细胞，胰岛素抵抗增加，炎症和纤维化增加以及其他生物学过程。拟议的研究将利用可靠的现有基础设施来迅速识别，招募和保留近期诊断为T1D或 T2D。该研究将包括过去三个月中诊断为糖尿病的1600名研究参与者在过去的90天内患有已知的Covid-19感染，最近诊断为糖尿病的感染过去一年中已知的Covid-19感染。该研究将利用PCORNET，这是一个独特的国家网络超过60多个具有电子健康记录（EHR）数据的卫生系统超过8000万患者和往绩记录成功的研究招聘。我们将询问EHR记录以迅速确定潜在的研究主题糖尿病的最新诊断，并通过患者门户，电话，面对面遭遇和其他方法。我们还将利用T1D交易所（T1DX），这是一个由54个糖尿病中心组成的国家网络还有17,000名T1D患者的在线患者注册表。同意的参与者将定期参加 Web/Mobile或电话调查利用先前开发的Redcap/Twilio平台。参与者会也要进入定期的血清学测试站点，子样本将参与更强大的测试葡萄糖耐受性，生物标志物和血管功能。这些数据将通过纵向EHR数据补充从参与站点和整个PCORNET。参与者将被遵循2年。 AIM 1将检查是否最近患有最近COVID-19的T2D患者更有可能具有较差的血糖控制，增加了炎症和胰岛素抵抗增加比没有最近COVID-19的患者。 AIM 2会检查是否是否最近患有最近COVID-19的T1D患者更有可能具有较差的血糖控制，增加了与没有最近COVID-19的患者相比，Beta细胞功能的炎症和更快的降低。目标3意志评估一部分糖尿病患者的子集，以检查COVID-19是否与较差的血管功能有关，炎症和高凝性增加。 AIM 4将探讨基因组/社会/环境的作用炎症和代谢功能的因素。 AIM 5将利用EHR数据探索Covid-19的作用和199跨大流行的糖尿病发育和与糖尿病相关的结果的共同治疗。这研究将由与19岁的Covid-19，Covid-19的急性后遗症有关的团队领导。（PASC），儿童和成人的肥胖和糖尿病，流行病学研究，信息学，卫生服务研究，基因组学，代谢组学，生理学，患者和家庭参与以及其他领域。提议工作将对Covid-19和糖尿病之间的关系有更深入的了解，可以支持未来的干预措施和公共卫生方法来改善健康。