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 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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May 2020

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...

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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...

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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...

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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) trial, which established the efficacy of intensive lifestyle modification or metformin in decreasing incidence of type 2 diabetes...

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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...

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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...

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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...

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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...

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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...

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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...

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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...

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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...

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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...

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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...

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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...

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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...

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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...

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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...

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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...

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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...

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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...

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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...

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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...

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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...

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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...

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January 2020

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...

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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...

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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)...

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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...

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