The Impact of Diabetes on Patients with Glomerular Disease: CureGN-Diabetes

糖尿病对肾小球疾病患者的影响：CureGN-Diabetes

基本信息

批准号：
10370293
负责人：
Andrew Stephen Bomback
金额：
$ 65.11万
依托单位：
UNIV OF NORTH CAROLINA CHAPEL HILL
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-03-11 至 2027-01-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10370293
关键词：
Address Adult Affect Ancillary Study Area Biological Markers Biopsy Calcineurin inhibitor Cardiovascular Diseases Cardiovascular system Caring Categories Characteristics Chronic Kidney Failure Clinical Clinical Data Collection Complex Data Data Collection Diabetes Mellitus Diabetic Nephropathy Diagnosis Disease Enrollment Epidemiology Exclusion Focal Segmental Glomerulosclerosis Foot Process Funding Future Healthcare Histologic Histopathology Hospitalization IGA Glomerulonephritis Immune System Diseases Immunosuppression Individual Infection Infrastructure Kidney Knowledge Lesion Lesion by Morphology Letters Literature Longitudinal Studies Longitudinal cohort Longitudinal observational study Mediating Membranous Glomerulonephritis Minority Morbidity - disease rate Morphology Movement National Institute of Diabetes and Digestive and Kidney Diseases Natural History Nodular glomerulosclerosis Outcome Parents Pathologic Pathology Pathway interactions Patient Care Patient-Focused Outcomes Patients Pattern Persons Population Productivity Protocols documentation Quality of life Renal glomerular disease Research Research Personnel Resources Risk Sclerosis Severities Site Specificity Standardization Steroids Time Tissues Treatment outcome United States National Institutes of Health Variant Work biobank clinical research site cohort comorbidity cost data curation data harmonization diabetic diagnostic value disease diagnosis disease heterogeneity follow-up immunomodulatory therapies improved individual patient infection risk kidney biopsy multi-ethnic personalized care precision medicine predict clinical outcome primary outcome prognostic value prospective recruit tool treatment risk

项目摘要

ABSTRACT Primary glomerular diseases often occur in patients with prexisting diabetes mellitus, a common and systemic illness which increases the risk for infection, cardiovascular and progressive chronic kidney disease. The diagnosis, pathology, treatment, complications and outcomes of primary glomerular diseases may be modified by the risks associated with diabetes, however, the literature is greatly lacking in this area. Such information is crucial to optimizing beneficial therapies and minimizing complications and cost in the care of glomerular disease patients. CureGN-Diabetes is a prospective, longitudinal observational study of patients with one of the four most common primary glomerular diseases: IgA nephropathy (IgAN), focal segmental glomerulosclerosis (FSGS), minimal change disease (MCD), and membranous nephropathy (MN). It is an ancillary study to the parent CureGN study which is currently in its second cycle of NIH/NIDDK funding and has enrolled 2400 patients with IgAN, FSGS, MCD and MN, but excluded patients with diabetes prevalent at the time of glomerular disease diagnosis. The exclusion of diabetes had an unexpected and disproportionate effect on recruitment among minorities and sites in the southeastern U.S., as these populations suffer among the highest rates of diabetes. CureGN-Diabetes will fill this gap in the CureGN study and will also leverage control data from the TRIDENT Study, a longitudinal cohort of patients with biopsy proven diabetic glomerulosclerosis. Harmonization of data from CureGN, TRIDENT and CureGN-Diabetes, will provide an opportunity to study the effects of primary glomerular disease alone, diabetic glomerulosclerosis alone and the combined effects of primary glomerular disease AND diabetes. The aims of CureGN-GN Diabetes include: 1) To recruit and follow a multiethnic cohort of 300 adult patients with diabetes mellitus and biopsy documented IgAN, FSGS, MN, and MCD; 2) To assess the impact of diabetes on presenting features (clinical and histopathologic) and long term outcomes in patients with IgAN, FSGS, MN, and MCD; AND 3) To identify individual and clusters of morphologic lesions which carry diagnostic and prognostic value. A strength of this study is the significant overlap between investigators and clinical sites involved in the CureGN and TRIDENT studies, which will expedite the efficiency and productivity emanating from this work. Furthermore, the CureGN-Diabetes Study will add to the available biorepositories of CureGN and TRIDENT, enriching the resources for future biomarker and mechanistic studies of primary glomerular disease versus diabetes-mediated pathways

抽象的原发性肾小球疾病通常发生在患有糖尿病的患者中，糖尿病是一种常见的全身性疾病疾病会增加感染、心血管疾病和进行性慢性肾病的风险。这原发性肾小球疾病的诊断、病理、治疗、并发症和结果可能会改变然而，由于与糖尿病相关的风险，该领域的文献非常缺乏。此类信息是对于优化有益疗法并最大限度地减少肾小球护理的并发症和成本至关重要疾病患者。 CureGN-Diabetes 是一项针对患有以下疾病之一的患者的前瞻性纵向观察研究四种最常见的原发性肾小球疾病：IgA 肾病 (IgAN)、局灶性节段性肾病肾小球硬化症（FSGS）、微小病变（MCD）和膜性肾病（MN）。它是一个母体 CureGN 研究的辅助研究，该研究目前正处于 NIH/NIDDK 资助的第二个周期，并且已经招募了 2400 名 IgAN、FSGS、MCD 和 MN 患者，但排除了当时流行的糖尿病患者肾小球疾病诊断时间。排除糖尿病产生了意想不到且不成比例的效果关于在美国东南部的少数族裔和地点进行招募，因为这些人口在糖尿病发病率最高。 CureGN-Diabetes 将填补 CureGN 研究中的这一空白，并且还将利用控制来自 TRIDENT 研究的数据，该研究是活检证实患有糖尿病肾小球硬化症的患者的纵向队列。来自 CureGN、TRIDENT 和 CureGN-Diabetes 的数据的协调将为研究单独原发性肾小球疾病、单独糖尿病肾小球硬化的影响以及以下因素的综合影响原发性肾小球疾病和糖尿病。 CureGN-GN 糖尿病的目标包括： 1) 招募和跟踪由 300 名成年糖尿病患者组成的多种族队列，活检记录有 IgAN、FSGS、MN 和 MCD； 2) 评估糖尿病对临床特征（临床和组织病理学）和长期的影响 IgAN、FSGS、MN 和 MCD 患者的结局；以及 3) 识别个体和群体具有诊断和预后价值的形态学病变。这项研究的一个优点是显着参与 CureGN 和 TRIDENT 研究的研究者和临床中心之间存在重叠，这将加快这项工作的效率和生产力。此外，CureGN-糖尿病研究将添加到 CureGN 和 TRIDENT 的可用生物存储库中，丰富未来生物标志物的资源原发性肾小球疾病与糖尿病介导途径的机制研究