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 2020
Mechanisms and Interactions of SARS-CoV-2 and COVID-19 in Organ Systems and Outcomes of Specific Interest to NIDDK
Emerging evidence suggests that organs and tissues that manifest diseases within NIDDK’s mission are targeted by SARS-CoV-2, which contributes significantly to COVID-19 morbidity and leads to organ-specific complications after recovery from infection. How this...
Advancing Basic and Translational Research for Benign Genitourinary Conditions: Intersection of BPH, Male LUTs, and Aging
Benign prostatic hyperplasia (BPH) affects 50% of men over age 50. Ninety percent of men over age 80 become affected. Often men with BPH present with lower urinary tract symptoms (LUTS) and first-line treatment of such symptoms include...
APOL1 Variants in Patients Undergoing Kidney Transplantation
African Americans have higher incident end-stage renal disease rates than European Americans. APOL1 variants on Chromosome 22 have been linked with non-diabetic kidney disease, focal glomerulosclerosis and hypertension-attributed kidney disease. Kidney transplantation is...
Continuation of the Human Pancreas Analysis Program (HPAP)
This limited competition would support a single cooperative agreement application to continue the mission of the existing Human Pancreas Analysis Program (HPAP). The HPAP is a large data- and resource-generation program that performs deep phenotyping...
Diabetes Prevention Program Outcomes Study (DPPOS) Continuation
The Diabetes Prevention Program Outcomes Study (DPPOS) is the longitudinal follow-up of the cohort that participated in the Diabetes Prevention Program (DPP) trial, which established the efficacy of intensive lifestyle modification or metformin in decreasing incidence of type 2 diabetes...
Diabetes Research Centers (DRCs)
The Diabetes Research Centers (DRCs) program has been ongoing for over 40 years with current support of funding for 16 DRCs across the US. The DRCs promote new discoveries and enhance scientific progress through support of cutting-edge basic and clinical research...
Diabetic Foot Consortium – One Year Extension
Foot ulcers are a common and costly complication of diabetes that burdens patients and their families with lengthy and often unsuccessful treatments that frequently result in a lower extremity amputation. The NIDDK Diabetic Foot Consortium (DFC) was established in...
Epidemiology of Diabetes Interventions and Complications (EDIC) – Continuation of Core Activities
In 1993, after the Diabetes Control and Complications Trial (DCCT) showed that intensive type 1 diabetes (T1D) therapy delayed the onset and progression of microvascular complications, EDIC began to study the long-term effects...
Exploratory and Developmental HIV/AIDS Research within the NIDDK’s Mission
This initiative encourages innovative basic, translational, or clinical research on NIH HIV/AIDS priority research within the mission of the NIDDK by facilitating exploratory and developmental research that might form the basis of a...
George M. O'Brien Kidney Research Centers
The George M. O’Brien Kidney Centers Program started in 1987 after specific statutory authority was provided in 1985. The Kidney Program originally funded four Centers. Currently eight centers are funded, supporting basic, clinical and translational research...
Improving Access to Kidney Transplantation through Organ Optimization and Enhanced Evaluation
This concept is to host a workshop focused on optimization and evaluation of donor kidneys for transplant, with the goal of stimulating research and technology development that could...
Kidney Precision Medicine Project
The objectives of the Kidney Precision Medicine Project (KPMP) are to ethically and safely obtain and evaluate human kidney biopsies from participants with Chronic Kidney Diseases (CKDs) or Acute Kidney Injuries (AKIs), create a kidney tissue atlas that incorporates...
Limited Competition: Continued Follow-up of Subjects and Initiation of a Second Case-control Cohort in The Environmental Determinants of Diabetes in The Young Study (TEDDY)
Type 1 diabetes is a serious and burdensome chronic disease that usually affects children and young adults. The rate of type 1 diabetes incidence is rising worldwide, especially in the very young. These findings suggest that environmental triggers are responsible for...
Multidisciplinary Research on HIV Cure within the Mission of the NIDDK
The initiative encourages multidisciplinary teams to engage in basic and/or clinical HIV cure research within the mission of the NIDDK. This includes characterization of HIV reservoirs and mechanisms associated with viral latency, post-treatment control, and viral rebound...
Multidisciplinary Research on HIV Pathogenesis within the Mission of the NIDDK
This initiative encourages multidisciplinary teams to elucidate fundamental mechanisms of comorbidities, coinfections, or complications associated with Human Immunodeficiency Virus (HIV) or its treatment that are within the mission...
New Directions in Urologic Chronic Pain and Lower Urinary Tract Disorders: Moving Toward Improved Trials and Treatment
Benign urologic conditions characterized by chronic pain and lower urinary tract symptoms are highly prevalent and result in high morbidity in patients. Recent NIDDK studies, such as the MAPP Network, the LURN, and others, as well as...
NIDDK Education Program Grants
A core principle of the NIDDK’s vision is to promote the next generation of research investigators by fostering exceptional training and mentoring opportunities. The NIDDK promotes training programs across the career stages...
NIDDK Funding for Multi-Center Clinical Studies through Cooperative Agreements
NIDDK currently supports the funding of multi-center clinical studies through a U34 planning grant followed by a separate application for the clinical trial or study (U01). Multi-center clinical study proposals cannot be submitted as...
Non-ablative Immunotherapy to Prepare Bone Marrow for Transplant
With the advent of Chimeric Antigen Receptor T-cells use for targeting cancer (“non-self”) tissue, the idea of targeting specific hematopoietic cells was a logical extension. CAR-T therapies for nonmalignant hematologic diseases is on the forefront of discovery. This workshop will explore...
Overcoming Barriers to Wider Adoption of Home Dialysis
Home dialysis therapies remain vastly underused in the United States. The executive order on kidney health set a goal for significantly increasing use of home therapies, which include peritoneal dialysis and...
Pediatric Centers of Excellence in Nephrology (PCEN)
This initiative proposes to renew the current Pediatric Nephrology Research Centers program, recognizing the under-populated pediatric nephrology research landscape. It continues to address the need to sustain research projects critical to understanding kidney disease in infants, children and adolescents...
Priority HIV/AIDS Research within the Mission of the NIDDK
This initiative encourages HIV/AIDS-related research within the mission of the NIDDK that is aligned with NIH HIV/AIDS research priorities. The most recent priorities are outlined...
Re-issuance of Time-sensitive Obesity Policy or Program Evaluation (R01) PAR-Clinical Trial Not Allowed
This re-issued PAR would continue an accelerated review and award process to support time-sensitive research to evaluate a new policy or program that is likely to influence obesity related behaviors (e.g., dietary intake, physical activity, sedentary behavior, and sleep) and/or weight outcomes in an effort...
Renewal of the NIDDK Inflammatory Bowel Disease Genetics Consortium (IBDGC)
The NIDDK IBD Genetics Consortium (IBDGC, or the Consortium) has led international efforts which have resulted in the identification of >250 IBD risk loci, enabling a reclassification of IBD into three clinical subtypes...
Understanding and Targeting the Pathophysiology of Youth-onset Type 2 Diabetes
The obesity epidemic has resulted in an increase in type 2 diabetes (T2D) in youth, particularly during puberty and in minority populations. SEARCH, TODAY and other studies have shown that glycemic control is poor in youth with T2D...
January 2020
Cardiovascular Biorepository for Type 1 Diabetes
Cardiovascular complications significantly shorten the lives of individuals with type 1 diabetes (T1D). The standard risk factors for cardiovascular disease (CVD) only partially explain this increased mortality because...
Early Phase Clinical Trials
Improving prevention and treatment of disease requires large clinical trials to ensure efficacy and safety of the proposed intervention. The first step in this process is often exploratory, short-term work to investigate new ideas. Preliminary data are needed...
Patient-oriented Research to Mitigate Health Disparities and Lessen the Burden of Chronic Diseases
The purpose of this initiative is to conduct person-oriented clinical research studies developing strategies to mitigate health disparities in people with one or more chronic disease/conditions within the mission of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)...
Understanding and Reducing Cardiovascular Disease in Type 1 Diabetes Mellitus
The goal of this initiative is to promote research that enhances the understanding of the pathophysiology and epidemiology of cardiovascular disease (CVD) among individuals with type 1 diabetes (T1D), and the development of interventions...
September 2019
Adding a Step to STEP-UP Research Supplements
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...
Administrative Supplements to Center P&F Programs to Support Emerging Physician Scientists
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...
Advanced Tools for Continuous Monitoring of Nutrients and Metabolites
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...
Catalyst Award in Digestive Diseases, Liver, Nutrition, and Obesity Research
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...
Centers for Diabetes Translation Research
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...
Continuation of Action for Health in Diabetes (Look AHEAD)
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...
Continuation of the Gastroparesis Clinical Research Consortium (GPCRC)
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...
Continued NIDDK Participation in ASA-24, Self-Administered 24hr Dietary Recall
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...
Continued NIDDK Participation in the National Collaborative on Childhood Obesity Research (NCCOR)
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...
Cooperative Agreement for Transplanting Hepatitis C+ Kidneys into Hepatitis C- Recipients
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...
Development of Enabling Tools for Biomedical, Behavioral, and Clinical Research in KUH
The purpose of this initiative is to promote development of enabling tools and technologies in the areas of kidney, urologic, and hematologic diseases...
Diabetes Prevention Program Outcomes Study (DPPOS) Continuation
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...
Dietary Biomarkers of Intake and Exposure
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...
dkNET New Investigator Pilot Award in Bioinformatics
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...
Extension of the Urinary Stone Disease Research Network (USDRN) PUSH Study
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)...
GI Sampling and Monitoring Tools/Devices for Diet-Host-Microbiome Interactions
This initiative supports the development of tools/devices for sampling or monitoring gastric mucosal- diet and microbial interactions...
Institutional Training Network Award
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...
Interventions to Improve Outcomes After AKI
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...
KUH Innovative Science Accelerator (ISAC) Awards
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...
Liver Cirrhosis Network
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...
Pediatric Acute Liver Failure Immune Response Network (PALF IRN)
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...
Re-competition of the George M. O’Brien Urology and Development Centers Program and Interactions Core
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...
Re-competition of GUDMAP – Lower Urinary Tract Develop Molecular Anatomy Project
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...
Re-competition of Institutional Career Development for Epidemiology of Urologic Diseases (UroEpi)
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...
Re-competition of the KUH Predoctoral to Postdoctoral Fellow Transition Award
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...
Reconfiguration of GUDMAP/RBK Data Hub
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...
Research Supplements to Train and Retain Study Coordinators to Support Clinical Trials in NIDDK Disease areas
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...
SEARCH Registry Expansion
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...
Stimulating Hematology Investigation: New Endeavors (SHINE) Topic: Bioinformatic Exploration of Hematology Cohort Data
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”...
Summer Research Experiences Utilizing SPARC-Generated Resources
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)...
Understanding Chronic Kidney Diseases of Uncertain Etiology in Agricultural Communities
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...
May 2019
Accelerating Medicines Partnership in Type 2 Diabetes (AMP T2D) Renewal
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...
Bioinformatics Training in Diabetes, Endocrinology and Metabolic Diseases Research Areas
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...
Catalyst Award in Diabetes, Endocrinology and Metabolic Diseases
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...
Centers of Excellence in Hematology Renewal
This concept proposes to continue to foster multi-disciplinary research, collaboration, and resources supporting hematology research...
Food Insecurity and HIV
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...
Molecular Mechanisms of Metabolic Adaptation to Weight Change
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...
National Survey on Prevalence of Kidney Disease (NHANES)
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...
NIDDK’s Therapeutics Discovery Translational Pipeline
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...
Obesity and HIV
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...
Optimization of NIDDK Investment in Large Research Programs
This concept proposes an updated strategy to promote effective, collaborative research studies within the Institute’s mission...
Pathways for Review and Release of Available NIDDK Repository Samples
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...
Polycystic Kidney Disease Center Program
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...
Prevention of Lower Urinary Tract Research Consortium (PLUS) Renewal
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...
(Re)Building a Kidney – A Grand Challenge Renewal
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...
Support of Emerging Physician Scientists to Develop Careers in Diabetes, Endocrinology, and Metabolic Diseases
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...
Supporting Descriptive Epidemiology of Non-Malignant Urologic Disease
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...
Supporting Research in Chronic Pancreatitis, Diabetes, and Pancreatic Cancer (CPDPC)
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...
Supporting Transition to Independence for NIDDK Career Training Awardees
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...
United States Renal Data System (USRDS)
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...