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

September 2019

Over the past 20 years NIDDK has supported the Short-Term Research Experience for Underrepresented Persons (STEP-UP) Program that has worked to establish pathways and opportunities for both high school and undergraduate students to pursue opportunities in research...

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There is growing concern that the number of MDs conducting clinical research in diabetes and related metabolic diseases is diminishing. Although NIDDK currently provides multiple opportunities to foster research careers in biomedical science, the success rate of MDs applying for and receiving an individual award after the completion of their clinical residency or fellowship is lower than that for PhDs completing a dedicated postdoctoral research fellowship...

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Recent advances in precision nutrition and circadian metabolism research have come from studies utilizing continuous subcutaneous glucose monitors, often integrated with widely available mobile devices. However, diet leads to excursions in thousands of nutrients and metabolites, some of which are linked to the metabolism of gut microbiota. To advance precision nutrition, microbiome, and circadian metabolism research, there is a critical need to develop tools and devices that can continuously monitor a broader range of nutrients and metabolites...

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Currently, the vast majority of NIDDK’s funded awards consist of hypothesis-driven R01-based research that is submitted and reviewed by standard study sections in CSR and NIDDK. Grant applications that lack extensive preliminary data or challenge current paradigms do not typically fare well in traditional NIH review panels. In some instances, this can be a barrier to achieving field-disrupting advances...

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The Centers for Diabetes Translation Research (CDTR) program was established in 2011 to expand and more broadly advance beside to practice research in diabetes. CDTRs provide an array of national research resources to advance the field of diabetes translation, address diabetes-related disparities, and develop the scientific workforce...

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The Look AHEAD (Action for Health in Diabetes) randomized clinical trial sought to determine the long-term health effects of a behavioral lifestyle program designed to produce weight loss in people with overweight/obesity and Type 2 diabetes. Participants were assigned to either an Intensive Lifestyle Intervention (ILI) group or a Diabetes Support and Education (DSE) group, and the intervention was delivered for up to 11 years...

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The purpose of this initiative is to continue clinical trials, longitudinal clinical observation, testing and specimen collection in adult and pediatric patients with gastroparesis, a disorder which has substantial gaps in mechanistic understanding, few effective interventions, and significant unmet needs to address substantial morbidity...

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Assessment of dietary intake is a key component of obesity surveillance, obesity prevention/treatment studies, and risk or management of many other conditions relevant to NIDDK’s mission. The gold standard method for dietary assessment is a 24 hour dietary recall; however, it is expensive and impractical for large-scale research...

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The National Collaborative on Childhood Obesity Research, established in 2009, is a public-private partnership bringing together four major research funders: the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), the Robert Wood Johnson Foundation (RWJF), and the U.S. Department of Agriculture (USDA) — to accelerate progress in reducing childhood obesity in America...

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Kidney transplantation is the preferred treatment for end stage kidney disease but is limited by a severe scarcity of donor organs. Donor kidneys infected with hepatitis C virus (HCV) may represent a potentially underutilized source of donor kidneys...

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The purpose of this initiative is to promote development of enabling tools and technologies in the areas of kidney, urologic, and hematologic diseases...

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The Diabetes Prevention Program Outcomes Study (DPPOS) is the longitudinal follow-up of the cohort that participated in the Diabetes Prevention Program (DPP). DPP established the efficacy of intensive lifestyle modification or metformin in decreasing incident type 2 diabetes in individuals at high risk for diabetes...

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Nutritional epidemiological studies explore the role of dietary constituents in human health and disease. Dietary exposure information, which is critical for establishing such associations, is often derived from self-reported Food Frequency Questionnaires (FFQ), food diaries and other similar dietary assessment instruments. However, these instruments are often liable for systematic errors and further confounded by incomplete databases used for converting the intake information...

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As methods that generate large volumes of complex data become more common in biomedical research, there is a growing need to develop a workforce that can use and further refine the computational approaches needed to interrogate complex data...

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The NIDDK’s Urinary Stone Disease Research Network (USDRN) seeks to improve our understanding and treatment of urinary stone disease. The USDRN is currently conducting two clinical protocols, the Prevention of Urinary Stones with Hydration (PUSH) Study (a randomized clinical trial) and the Study to Enhance Understanding of Stent Associated Symptoms (STENTS) (an observational cohort study)...

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This initiative supports the development of tools/devices for sampling or monitoring gastric mucosal- diet and microbial interactions...

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The KUH division of the NIDDK aims to reshape and refocus its Institutional Training Award (T32) Program. The new program will have fewer, larger awards designed to cultivate a vibrant and dynamic network of people and resources across an entire institution to engage, recruit, prepare and sustain the next generation of KUH researchers...

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A consortium comprised of a Data Coordinating Center and 3 Clinical Centers will develop an approach to enrolling patients with AKI, and develop specific interventions with appropriate control groups, to evaluate their efficacy in improving AKI outcomes after hospitalization...

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This initiative aims to establish a new program to fund small pilot projects via a streamlined process to support cutting-edge research and accelerate true innovation in areas of science of interest to the kidney, urology and hematology research communities...

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The establishment of a Liver Cirrhosis Network proposed in this initiative would address several pressing issues including optimal and noninvasive means of diagnosis, staging or monitoring as well as basic pathophysiology, classification and management. An opportunity exists for an interventional trial aimed at ameliorating the course and altering the natural history of liver cirrhosis...

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Pediatric acute liver failure (PALF) is a complex, rapidly progressive, and potentially devastating clinical syndrome that is the final common pathway for many acute liver diseases in children; some known and others yet to be identified. In up to one-third of cases of PALF, the cause cannot be ascertained...

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The George M. O'Brien Urology Research Centers and Developmental Centers for Interdisciplinary Research in Benign Urology serve to advance the NIDDK’s mission in benign urologic conditions by supporting innovative and highly meritorious research and training and career development programs...

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This GUDMAP initiative focuses on a detailed interrogation of the lower urinary tract to identify new cell types and establish their cell signatures, categorize developmental events, and interrogate a well-chosen set of murine disease or injury models for kidney and lower urinary tract to define disease-associated cell signatures...

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This initiative provides institutional career development support to mentor and develop a proficient and self-sustaining cohort of investigators who can conduct epidemiologic research in benign urological diseases and conditions...

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Interdisciplinary research is increasingly being recognized as the foundation for the development of new scientific knowledge and discovery. Many research programs currently funded by the Division of Kidney, Urologic and Hematologic diseases (KUH) require expertise from a variety of scientific disciplines...

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The NIDDK supports two consortia, GenitoUrinary Development Molecular Anatomy Project (GUDMAP) and the ReBuilding a Kidney (RBK), in which data are shared upon validation with the research community. This initiative is to consolidate the Data Hubs for the GUDMAP and RBK...

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Full representation of the United States population in clinical trials/studies is critical to ensure the quality of medical care, integrity of the biomedical research enterprise, and greater participation of all relevant communities in clinical trials/studies. NIDDK proposes to provide research supplements to clinical trial (and study) programs to recruit and train Study Coordinators from the respective population groups to increase their participation in clinical trials and clinical studies programs in NIDDK mission areas...

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The SEARCH for Diabetes in Youth Study was established in 2000 as a joint project between CDC and NIDDK to conduct population-based surveillance of diabetes in youth (individuals <20 years of age). SEARCH provides the only such data in the U.S., as national surveys (e.g., NHANES) only cover adults...

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The SHINE program was started in FY2010 as a pool of revolving funds to support emerging fields in hematology research. To ensure that the program meets its goal of supporting emerging fields in hematology research, we plan to hold a workshop and consider a new topic, “Tools for Mining Cohort Data”...

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The importance of peripheral nervous system regulation of organs and associated diseases of interest to NIDDK is increasingly evident, with expanding research activity in this space reflected by active, high profile NIH programs, such as SPARC (Stimulating Peripheral Activity to Relieve Conditions)...

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Chronic Kidney Diseases of Uncertain Etiology (CKDu) are recognized to cause end stage kidney failure in rural areas of many low and middle income countries, resulting in a large death toll among the working age population. Environmental factors are suspected, but there is a lack of compelling evidence for any agent, while family and geographic clustering raise the possibility of an unrecognized genetic susceptibility...

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May 2019

This concept proposes to continue the pre-competitive collaboration embodied in the AMP T2D program and aims to (1) improve understanding of the genetic architecture of T2D and its complications; (2) identify, validate, and perturb disease-driving networks; and (3) make the resulting knowledge broadly available to the scientific community to foster fundamental and clinical research and nominate potential biomarkers and drug discovery targets...

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This concept proposes supporting pre- and postdoctoral fellows to obtain interdisciplinary training from outstanding faculty sponsors in bioinformatics and scientific research relevant to the mission of NIDDK's Division of Diabetes, Endocrinology and Metabolic Diseases...

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This concept seeks to foster paradigm shifting research that applies emerging technologies to Diabetes, Endocrinology and Metabolic Diseases (DDEMD) scientific areas or that addresses bold concepts not yet supported by substantial preliminary data...

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This concept proposes to continue to foster multi-disciplinary research, collaboration, and resources supporting hematology research...

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The goal of this concept is to improve health outcomes for people with HIV or people at risk for HIV by understanding how food insecurity and other important determinants of health impact health seeking behavior and treatment adherence to antiretroviral therapy...

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This concept seeks to explore the extent, duration, and potential mechanisms for metabolic adaptation following weight loss, which may contribute to the difficulty many experience in maintaining weight loss...

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The goal of this proposal is to provide support for the National Health and Nutritional Survey. Among other features, this survey has served as the key indicator of the prevalence of chronic kidney disease in the United States for more than 20 years...

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This concept proposes to continue the Therapeutics Discovery Translational Pipeline with a focus on novelty, innovation, and therapeutics where there is clear, unmet clinical need. This Pipeline stimulates research and technology development to pharmacologically validate novel drug targets and/or small molecule chemical scaffolds or non-viral biologics that are not currently a focus within the biotechnology and pharmaceutical industries...

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This concept seeks to elucidate antiretroviral agent-mediated obesogenic processes in the context of people at risk for HIV on pre-exposure, by mechanistic interrogation of both viral-mediated and antiretroviral agent-mediated changes in fat biology, inflammation, and metabolism...

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This concept proposes an updated strategy to promote effective, collaborative research studies within the Institute’s mission...

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This concept seeks to provide a pathway for researchers to request access to valuable samples housed in the NIDDK Central Repository, allowing for access to requested samples based on scientific merit of the proposed project and the scarcity/abundance of the specific samples requested...

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This concept aims to develop an interactive consortium to foster research and training in Polycystic Kidney Disease (PKD) and disseminate research resources essential to the study of PKD to the research community...

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This concept proposes to continue the successful PLUS consortium that is using qualitative and quantitative approaches to conduct studies to establish the scientific basis for future intervention studies promoting bladder health and/or preventing bladder conditions in adolescent and adult women...

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The long-term goal of this program is to develop and test advanced therapies for treatment of kidney injury or disease. This opportunity would support team of researchers representing diverse scientific disciplines to develop and test novel ways to stimulate regeneration or enhance productive repair in response to injury; or generate functional kidney tissue ex vivo for transplantation or engraftment...

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This concept is proposed to pilot a program to enable continuity of research experiences for licensed or board-eligible MDs or MD-equivalents engaged in clinical or basic research within the Division of Diabetes, Endocrinology and Metabolic Diseases’ mission...

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The goal of this proposal is to provide a resource for the research, lay and clinical community of indicating the descriptive epidemiology of non-malignant urologic diseases, serving as a parallel resource to existing projects for chronic and end stage kidney disease within KUH, and for diabetes and digestive diseases within NIDDK...

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This concept is proposed to improve mechanistic knowledge, diagnostic tests, and predictive measures for chronic pancreatic diseases and its complications, with the goal of supporting subsequent development of FDA approved specific treatments for pre-malignant diseases...

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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...

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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 would provide 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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