Concept Clearances

Approved Concepts for Requests for Applications (RFAs), Program Announcements (PAs), and Requests for Proposals (RFPs)

Concepts represent an early planning stage for potential NIDDK initiatives and describe their basic purpose, scope, and objectives. Through the Concept Clearance process, NIDDK receives input from the NIDDK Advisory Council regarding the merits of research concepts. Council approval of a concept does not guarantee it will become a funded initiative; that decision is made based on scientific and programmatic priorities and the availability of funds.

Concepts presented to the NIDDK Advisory Council will be posted on the NIDDK website to enhance transparency and make the NIDDK research community aware of potential initiatives. The resultant initiative, in the form of program announcements (PA/PAR/PAS), requests for applications (RFA), and requests for proposals (RFP), may differ from the concepts in the final wording of the titles or other programmatic or scientific aspects.

Concepts

May 2022

Parkinson’s disease (PD) is the second most common and fastest growing neurodegenerative disorder, with approximately 60,000 Americans diagnosed annually. The incidence of PD increases with age regardless of gender and treatments target only symptoms as no therapies exist for the neurodegeneration in PD...

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Urologic Chronic Pelvic Pain Syndrome (UCPPS),characterized by pain in the pelvic region usually associated with diverse urologic symptoms, is widely prevalent and highly debilitating for men and women. Despite numerous past clinical trial efforts there are currently no broadly effective therapies and clinical management is often based on trial and error...

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The purpose of this proposal is to build on current technology and ongoing clinical research to address barriers that limit progress toward physiological pancreatic hormone replacement open- and closed-loop systems...

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This initiative will support ancillary studies using samples from participating type 1 diabetes clinical trials and studies. These studies are expected to generate scientific discoveries on type 1 diabetes primary pathogenesis and on biomarkers of disease progression or clinical responses to interventions leading to improved prevention and cure of type 1 diabetes...

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Modern medicine lacks reliable tools, methods, and procedures for comprehensive and dynamic assessment of renal function that is inadequately captured by the GFR estimation, is inclusive of all renal compartment specific functions, and accurately measures diverse states, physiologic processes, and disease pathologies...

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Cystic Fibrosis (CF) is one of the most common, life-limiting genetic diseases. Cystic Fibrosis Related Diabetes (CFRD) is a poorly understood and clinically significant complication that affects about half of adult CF patients...

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Digital Health Technology has the potential to revolutionize the approach to health conditions within the NIDDK mission. Wearable and smartphone technologies enable collection of health-related data such as physiological variables, physical activity, dietary intake, sleep quality, behavioral input, and data related to social determinants of health, including environmental conditions or geolocations associated with adverse health outcomes...

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The NIDDK’s Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN) seeks to improve our understanding of urinary urgency and associated symptoms so that it can be better diagnosed and more effectively treated in the adult population...

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One major grand challenge in Type 1 Diabetes (T1D) is that the exact disease etiology still not fully understood. We do not know what triggers the disease initiation, how triggering events lead to perpetuating β-cell destruction, nor how the interactions of on-site cell types contribute. Solving this challenge is critical for early detection, prevention and forunderstanding its heterogeneity and subtypes...

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The Human Islet Research Network (HIRN) is major research initiative investigating basic and preclinical aspects of type 1 diabetes islet biology. The HIRN currently involves five consortia including the Consortium on Beta Cell Death and Survival (CBDS), Consortium on Human Islet Biomimetics (CHIB), Consortium on Modeling Autoimmune Interactions (CMAI), Consortium on Targeting and Regeneration (CTAR), and the Human Pancreas Analysis Consortium (HPAC)...

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Research from the HIRN-Consortium on Modeling Autoimmune Interactions (CMAI) and HIRN-Consortium on Human Islet Biomimetics (CHIB) has made tremendous progress in establishing reagents, tools, and models to study immune mediated diabetes. The proposed new HIRN-Consortium on Modeling of Autoimmune Diabetes (CMAD) will build upon these technologies to further our understanding of how human type 1 diabetes develops...

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The gastrointestinal (GI) microbiota, and mucosal interactions play a critical role in homeostasis, energy metabolism, host immunity, permeability, and transmission of metabolic signals along the GI-brain axis. Altered microbial composition and metabolism have been implicated in a variety of both communicable (i.e., infectious diseases) and non-communicable diseases including diabetes, obesity, inflammatory bowel disease (IBD), and cancer...

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Type 2 Diabetes (T2D) is a heterogeneous disease that encompasses individuals who are hyperglycemic, but lack specific markers of other forms of diabetes. As a result, T2D represents a “catch-all” diagnosis in which patients are grouped according to relatively simple measures of glycemia, irrespective of the underlying pathophysiology driving elevated blood glucose...

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Exposure to health impeding social determinants of health (SDOH) contributes to poor obesity, diabetes, and kidney disease outcomes. Adverse SDOH disproportionately affect economically disadvantaged and minority populations and contribute to avoidable health inequities that characterize NIDDK diseases...

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The KUH Summer Undergraduate Research Experience (R25) Program is a rapidly growing and increasingly popular mechanism to support early outreach to undergraduate students and bring these young, talented trainees into the KUH research community. These awards provide support for undergraduate students to participate in a 10-week hands-on research experience, paired with appropriate didactic training in the areas of kidney, urologic, and hematologic sciences...

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The overarching goal of the KUH FAMILY Training Coordinating Center is to provide a home for all KUH trainees and junior investigators. This initiative is intended to build on the momentum being generated by the U2C Institutional Network Awards, the R25 KUH Summer Undergraduate Research Experience Awards, and other KUH-sponsored scientific consortia and training mechanisms that are actively recruiting an increasing number of trainees into the KUH space...

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This is a proposal for a workshop to identify multidisciplinary, state of the art approaches, and scientific gaps in clinical and translational research focused on congenital obstructive uropathy. Prenatal urinary tract dilation (hydronephrosis) occurs in 1-2% of pregnancies and is bilateral in 20-40%; a substantial proportion is associated with obstruction at some level within the urinary tract...

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The purpose of this funding opportunity is to combine access to existing patient datasets and developmental ‘omic resources with innovative, more widely-applicable, software tools for identification of novel disease pathways, especially in non-malignant hematologic diseases...

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Emerging evidence suggests nuclear architecture (e.g. nuclear membrane/envelope, nucleoskeleton, and nuclear structure) significantly impacts cellular developmental states and gene expression, likely through regulation and modification of chromatin conformation and states...

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The purpose of this initiative is to expand the Physiology of the Weight Reduced State (POWERS) clinical trial consortium funded via RFAs DK-19-017 and -018, to allow for molecular analysis of tissues (blood, muscle, adipose and stool) collected during the study...

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NIDDK recognizes the need to increase diversity in the biomedical workforce. Data indicate that individuals from NIH-defined underrepresented groups enter biomedical science in lower numbers, are less successful at obtaining NIH grant support and are less likely to be promoted into leadership positions...

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Approximately half of hemodialysis patients experience debilitating fatigue following their treatment. A thematic study described this fatigue from the patient’s perspective as “Draining,” “You can’t get up, do nothing same day as treatment,” and “The rest of the day is trying to recover.”...

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The Rare and Atypical Diabetes Network (RADIANT) is multidisciplinary group of investigators with expertise in diabetes, clinical phenotyping, genetics, metabolomics, and bioinformatics at 14 clinical centers, 5 specialized laboratories, and a data coordinating center. RADIANT is enrolling individuals and families with rare and atypical diabetes for in-depth, phenotypic and genetic analyses to help characterize new subtypes of diabetes and to provide insights on mechanisms underlying more common forms of type 2 diabetes...

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The purpose of this initiative is to support observational and translational research to better understand the natural history of the primary glomerulopathies (GNs) in a range of adult and pediatric individuals; understand clinical and molecular factors associated with varied outcomes; and to provide a platform for further study of GNs via ancillary studies that harness data and biosample collections for discovery of underlying causes and treatment targets...

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The goal of this proposed initiative is to provide a data resource on incidence, prevalence, mortality, and cost of kidney disease in the United States, satisfying a Congressional legislative mandate (OBRA 1986). This resource provides an invaluable resource for renal epidemiologists and colleagues in other government agencies, as well as providing a ready access to data for young investigators...

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The goal of this proposal is to provide a resource for the research, lay, and clinical community for the descriptive epidemiology of non-malignant (“benign”) urologic diseases and disorders. This resource will serve as a critical platform to understand the burden of these diseases and disorders and for young investigators to acquire investigational skills in urologic epidemiology...

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The goal of this proposal is to enhance capability of currently-funded career development award recipients (“K” awardees) to conduct research as they complete their transition to fully independent investigator status. The opportunity would support limited scope projects that could include pilot and feasibility studies; secondary analyses of existing data; small, self-contained research projects; development of research methodology; and development of new research technology...

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NIDDK supports clinical research on the diseases of internal medicine and related subspecialty fields as well as many basic science disciplines, including end-stage liver disease. To understand the pathophysiology of the diseases that lead to end-stage liver disease it is essential for researchers to have access to liver tissue and cells from a variety of liver diseases as well as normal livers...

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This initiative is to support an initial workshop to engage stakeholders from across the spectrum of Benign Prostatic Hyperplasia (BPH) research and its connection to Male Lower Urinary Tract Symptoms (LUTS). Importantly, patient perspectives will be included to focus the research agenda on outcomes central to BPH/LUTS patients and their partners...

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January 2022

Adults with childhood-onset Type 1 Diabetes (T1D) have significant cognitive impairment compared to comparably aged individuals without diabetes. Impaired cognition may exacerbate difficulties associated with long-term diabetes management...

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This Funding Opportunity Announcement (FOA) will solicit new applications to the Consortium on Targeting and Regeneration (CTAR) that will continue to support the development of innovative strategies to increase or protect functional human beta cell mass in patients with Type-1 Diabetes (T1D)...

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The NIDDK information network (dkNET) was originally conceived in 2011 in response to community needs in Big Data biomedical research, with an initial focus on sharing of data and resources within the NIDDK research community. Since then, the needs and challenges...

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November 2021

The impact of pain on patient quality of life for diseases and conditions within the mission of the NIDDK is enormous. Despite prior research efforts, our understanding of the underlying biological and clinical contributors of pain remains limited...

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September 2021

The overarching goal of the Advancing Gender Inclusive Excellence (AGIE) - Coordinating Center is to support a coordinating center that will provide the organizational framework for the management, direction, and overall coordination of all common activities aimed at investigating...

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Repeated episodes of hypoglycemia result in impaired awareness of hypoglycemia (IAH) and blunting of counter-regulatory responses (CRR) required to restore normal glycemia. T1DM individuals with IAH experience severe hypoglycemic episodes with...

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Mass Spectrometry (MS)-based assays have several inherent advantages when compared to traditional ELISA. The main research goal of this initiative is to develop MS-based assays for peptides and proteins of interest to...

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The New Investigator Gateway Award in T1D Research is designed to ensure that a robust pipeline of talented new investigators will continue to embark on successful careers in T1D research. In addition to providing support for preliminary research...

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The overarching goal of this NIDDK Partnerships with Professional Societies to Enhance Scientific Workforce Diversity and Promote Scientific Leadership program is to support educational activities that enhance the diversity of the biomedical, behavioral, and clinical research workforce. This program focuses on...

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Critical to the success of the NIH mission is promoting diversity in the extramural scientific workforce. Over the years, NIDDK and OMHRC have initiated programs that have trained several thousands of individuals from communities underrepresented in the scientific workforce. However, very few of these efforts have...

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May 2021

The ChiLDReN Network has undertaken a comprehensive genomics effort across the various rare cholestatic liver diseases currently under study. As of February 2021, a total of 2581 whole exome sequences have been...

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This proposal seeks support for a pilot program using the established CareerTrac system for tracking outcomes of supported trainees in our institutional training programs. CareerTrac is housed within the Program Analysis Branch of NIEHS and provides data for short- and long-term program evaluation and portfolio analysis...

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This initiative will support the development of tools and experimental platforms for the purification and characterization of Extracellular Vesicles (EV) originating from the human pancreatic islet and its broader tissue environment in healthy individuals, and individuals with type 1 diabetes (T1D) or at-risk of developing the disease...

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The Chronic Kidney Disease in Children (CKiD) cohort study is a multi-site, transdisciplinary effort that has made foundational discoveries in understanding childhood kidney disease while creating a platform for additional clinical studies and...

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This concept proposes to renew support for the Chronic Renal Insufficiency Cohort (CRIC), a long-standing observational study of individuals with chronic kidney disease (CKD). The goals of the study are to identify risk factors for both progression of...

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Drug Induced Liver Injury (DILI) is the most common cause of acute liver failure in the US and the major reason for the FDA not to approve or to withdraw drugs from the US market, limiting therapeutic alternatives for patients...

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DDEMD has prioritized health equity research. A fundamental approach for tackling health disparities and promoting equity involves meaningful stakeholder engagement with individuals and communities that...

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Obesity in children remains a major public health problem, with the most recent prevalence among youth ages to 2-19 years estimated at 20%. Research suggests that high-risk growth trajectories emerge during infancy and early childhood and tend to persist, suggesting...

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Although our understanding of biology and disease continues to increase, there are still numerous failures to advance efficacious and safe therapeutics, leaving significant unmet medical needs. The NIDDK has established a presence in therapeutics translation and, through this initiative, created a route for innovative R01 applications to be solicited and appropriately reviewed...

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The NIH/National Medical Association (NMA) Travel Award Program and the Network of Minority Health Research Investigators (NMRI) are two longstanding programs within the NIDDK Office of Minority Health Research Coordination (OMHRC) that are designed to build capacity and promote outreach. Both programs...

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The purpose of the Development Of Clinician-Scientists in Diabetes research (Diabetes-DOCS) Program is to support the development of physicians committed to a career in diabetes research. The Diabetes-DOCS program is intended to remedy the dearth of pediatric endocrinologists and physicians from other specialties who conduct outstanding, innovative research into the causes and consequences of diabetes...

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The Trial to Assess Chelation Therapy 2 (TACT2) will test if edetate disodium-based chelation and oral multi-vitamins reduces cardiovascular events in people with diabetes and a history of myocardial infarction...

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The purpose of the High Impact, Interdisciplinary Science grants program is to support scientific studies that may lay the foundation for new fields of investigation within the mission of the NIDDK. The interdisciplinary approach encouraged by this FOA is expected to generate a research resource or tool and/or foster discovery-based or hypothesis-generating science that...

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There is an on-going need to support teams of investigators to propose studies that will contribute to a higher resolution understanding of the organization of the human pancreatic tissue environment by describing the composition and function of important components of the pancreatic islet and peri-islet tissue architecture, the cell-cell relationships...

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The iMALT clinical intervention trial utilizes a telemetric intervention to alter complications due to immune suppression non-adherence. iMALT was operational when the COVID-19 pandemic adversely affected the enrollment rate...

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Islet dysfunction is a hallmark of both type 1 and type 2 diabetes. Because of this, decades of study have produced an extensive understanding of islet biology, the vast majority focusing on beta-cells specifically or on islets as independent units distinct from the exocrine pancreas in which they are embedded...

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Exposure to health impeding social determinants of health (SDOH) contributes to poor obesity, diabetes, and kidney disease outcomes. Adverse SDOH disproportionately affect economically disadvantaged and minority populations and contribute to the avoidable health inequities that characterize NIDDK disease areas...

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Marginalized racial and ethnic groups who have been subject to structural racism experience disparate health outcomes relative to more privileged groups. Structural racism affects access to and quality of care, as well as access to social...

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Effective mentoring is critical for successful career advancement in academic biomedical research, particularly at early career stages where budding investigators begin to formulate their research focus, develop insights, and needed scientific skill sets. Researchers from underrepresented groups (URGs) typically receive less mentoring...

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The purpose of this initiative is to continue supporting research related to the role of lymphatics in health and disease in the digestive system. Lymphatics malfunctions have been implicated in several disease states including...

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This concept will solicit new and renewal applications for the Multidisciplinary Urologic Research (KURe) Career Development program. This institutional career development program was initiated in 2009 with the goal of recruiting young investigators into benign urological research...

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The National Centers for Metabolic Phenotyping in Live Models of Obesity and Diabetes (MPMOD) will provide complex, technically difficult metabolic, physiologic and behavioral phenotyping and consulting services to...

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The overarching goal of this initiative is to reduce health disparities in type 1 diabetes mellitus (T1D) through improving technology usage within individuals from minority racial and ethnic backgrounds. Significant disparities exist in both health outcomes and health technology usage within T1D. Health outcomes data indicate...

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Current clinical practice guidelines recommend lowering phosphate levels to the normal range in dialysis patients to mitigate morbidity and mortality from coronary calcification, however, we have no randomized controlled data to...

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The purpose of the Kidney, Urology or Hematology (KUH) Predoctoral to Postdoctoral Fellow Transition Awards (F99/K00) is to recruit exceptional graduate students from diverse research disciplines and backgrounds to pursue postdoctoral training focused on Kidney, Urology or Hematology (K, U, or H) research. Talented graduate students from disciplines including...

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The program on Promoting Organ and Tissue Donation Among Diverse Populations was initially launched in FY2002 to address the disparities in organ and tissue donation among racial and ethnic minority communities. To date, awarded projects have focused on community-based programs to increase...

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Foot ulcers are a common and costly complication of diabetes that burden patients and their families with lengthy and often unsuccessful treatments frequently resulting in a lower extremity amputation. The NIDDK Diabetic Foot Consortium...

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Early identification of type 1 diabetes (T1D) risk and the onset of autoimmunity provides the basis for a variety of major ongoing studies seeking to prevent or delay the disease. Ongoing research on the natural history of the development of T1D in at risk neonates has shown that early identification of those at risk can foster early diagnosis of T1D and...

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The Stimulating Urology Investigator Team Opportunity Research (SUITOR) program supports increased funding of interdisciplinary research focused on cycling topics of interest in benign urologic diseases and...

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The purpose of this funding opportunity is provide support for the development of innovative research projects led by faculty members from underrepresented populations in biomedical research and facilitate competitive R01or R01 equivalent applications to...

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January 2021

Progress toward preventing or treating HIV comorbidities, coinfections, and complications requires a thriving community of researchers with expertise at the intersection of HIV science with the biology of organs, tissues, and processes...

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The CITR began in 2001 after the success of the “Edmonton Trial” in 1999. It pools both retrospective and prospective data from 37 programs. Through 2020, there were 1410 allograft recipients, 1222 autograft recipients and 3390 islet preparations in its databases...

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This initiative will continue NIDDK's participation in the Fogarty Global Health Training Program. Since 2013, NIDDK has provided co-funding support for global health scholars who have been selected by the funded institutions and are conducting research within the mission interests of the NIDDK...

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One of NIDDK’s guiding principles is to promote a steady and diverse pool of talented new investigators. However, the NIDDK funded biomedical research workforce is continuing to age and unfortunately continues to lack much needed diversity to tackle the myriad of diseases impacting the nation and the globe...

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The Nutrition Obesity Research Centers (NORC) program has been an ongoing program for almost 40 years with support for 12 NORCs across the US. The NORCs promote new discoveries and enhance scientific progress through support of cutting-edge basic, clinical, and translational research related to nutrition science and/or obesity...

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Historically, opportunities in this country have been mired in discrimination and lack of resources based on a person’s zip code or skin color. However, to address the myriad of health problems facing the country and the world, it is imperative that the full diversity of the United States is engaged in the biomedical research workforce...

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The Silvio O. Conte Digestive Diseases Research Core Centers (DDRCC) program seeks to promote synergy between established investigators engaged in digestive and/or liver diseases research at domestic research institutions...

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The Small Grants for New Investigators to Promote Diversity in Health-Related Research (R21 Clinical Trial Optional), current FOA PAR-19-222, is a longstanding funding opportunity within the NIDDK Office of Minority Health Research Coordination (OMHRC) that is designed to support new investigators from diverse backgrounds, including individuals who are nationally underrepresented in biomedical and behavioral research...

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The primary objective of this cooperative agreement is to improve and standardize measurements and data interpretation of HbA1c and C-peptide assays across clinical systems and national programs...

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September 2020

One third of adults age 65 and greater have diabetes, and health care utilization and cost is highest for this population. There is significant heterogeneity in biologic, clinical, functional and socioeconomic factors affecting the clinical course and management of diabetes for...

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Type 2 Diabetes (T2D) is a chronic metabolic disorder usually characterized by insulin resistance and impaired insulin secretion. T2D is diagnosed by measuring glycemic parameters in blood (e.g., fasting blood glucose or HbA1c). It has become apparent that T2D is a heterogenous disease with a complex...

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This Funding Opportunity Announcement (FOA) will support the renewal of the Integrated Islet Distribution Program (IIDP) and will maintain support for its continuing mission to provide the scientific community with important islet resources for diabetes research. The IIDP facilitates the distribution of human islets to biomedical researchers by...

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Barrett’s esophagus (BE), a replacement of the normal squamous epithelium of the esophagus by columnar lined epithelium with intestinal metaplasia, is a complication of gastroesophageal reflux disease (GERD) and the only identifiable risk factor...

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Although genome-wide association studies (GWAS) have identified >250 loci associated with Inflammatory Bowel Disease (IBD), most of these loci include 5-20 genes of diverse functions. In order to promote the translation of the genetic associations into a deeper understanding of the pathophysiology of IBD...

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Trillions of microorganisms colonize the human gut and are collectively regarded as an exo-organ, playing a vital role in host health and disease. While increasing evidence indicates that microorganisms either directly or indirectly impact host physiology, including dietary metabolism, the mechanisms that connect microbial metabolism to host physiology are poorly understood. There are well known mechanisms for microbe-microbe interactions...

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Diabetes self-management education and support (DSMES) is efficacious in improving clinical outcomes and quality of life, thereby decreasing avoidable health care utilization and cost. While DSMES is recommended for all people with diabetes, many do not receive DSMES. Multiple barriers exist...

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Research has shown that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogenous teams. Across NIH, efforts to diversify the research workforce have taken many forms, but scientists from under-represented minority groups (URGs)...

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