Understanding and Targeting the Pathophysiology of Youth-onset Type 2 Diabetes Clinical Centers (U01 Clinical Trial Not Allowed) | RFA DK 21 002

Opportunity Information: Apply for RFA DK 21 002

The National Institutes of Health (NIH) released this Funding Opportunity Announcement (FOA), RFA-DK-21-002, titled "Understanding and Targeting the Pathophysiology of Youth-onset Type 2 Diabetes Clinical Centers (U01 Clinical Trial Not Allowed)." It is a discretionary funding opportunity using a cooperative agreement mechanism (U01), which means funded sites would be expected to work closely with NIH staff as partners in a coordinated program rather than operating with complete independence. The opportunity sits in the health and nutrition space (CFDA 93.847) and is structured around building a multi-site clinical consortium made up of clinical centers.

The central purpose is to recruit and follow a cohort of early pubertal youth who are at risk of developing type 2 diabetes (T2D), and to observe them longitudinally through puberty. Puberty is a critical window because insulin sensitivity and metabolic regulation change substantially during this period, and these physiologic shifts may unmask or accelerate pathways leading from insulin resistance and dysglycemia to overt youth-onset T2D. By tracking participants across this developmental transition, the consortium is meant to capture the timing and biologic sequence of changes that precede and accompany progression toward diabetes.

The FOA has two closely linked scientific goals. First, it aims to sharpen risk prediction: determining which young people with risk factors or prediabetes are truly on a trajectory toward youth-onset T2D, and identifying the determinants that drive progression from prediabetes to diabetes. The practical reason for this is prevention. If the field can more accurately identify who is most likely to progress, prevention approaches can be better targeted, better timed, and ultimately tested more efficiently. Second, it aims to deepen understanding of the physiologic drivers of youth-onset T2D, with an emphasis on insights that could lead to improved strategies for glycemic control and for preserving pancreatic beta cell function. Beta cell decline is a key issue in youth-onset T2D, which often appears to have a more aggressive course than adult-onset disease, so the emphasis on mechanisms that influence beta cell health is an important translational angle.

Because the activity is framed as "Clinical Trial Not Allowed," the work supported under this FOA is intended to be observational and mechanistic rather than interventional in the sense of testing a prospective assignment to an intervention for health outcomes. In other words, the consortium is designed to build a richly characterized cohort and generate data that can later support development and testing of targeted prevention or treatment strategies, rather than conducting those trials within this specific U01 award.

Eligibility is broad across U.S.-based organizational types, reflecting an intention to build a diverse, capable network of clinical recruitment and research sites. Eligible applicants include state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations that are not federally recognized; public housing authorities and Indian housing authorities; nonprofits with and without 501(c)(3) status (excluding higher education institutions in those categories); for-profit organizations (other than small businesses); and small businesses. The FOA also explicitly encourages participation from a range of mission-focused and historically underrepresented institution types, including Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions.

At the same time, the FOA draws clear boundaries around foreign involvement. Non-domestic (non-U.S.) entities and non-domestic foreign institutions are not eligible to apply. In addition, non-domestic components of U.S. organizations are not eligible, and foreign components (as defined by the NIH Grants Policy Statement) are not allowed. This signals that the consortium, recruitment, and funded research activities are intended to be conducted entirely within eligible U.S. organizational structures and locations.

Administrative details included in the source information indicate the opportunity was created on July 14, 2021, with an original closing date of March 3, 2022. The agency is the NIH, and the award ceiling and expected number of awards are not specified in the provided excerpt. Overall, the FOA is best understood as NIH support for building a coordinated set of clinical research centers that can recruit at-risk early pubertal youth, follow them carefully through puberty, and produce the predictive and mechanistic knowledge needed to design smarter prevention efforts and more effective approaches to preserve beta cell function and manage glycemia in youth-onset type 2 diabetes.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Understanding and Targeting the Pathophysiology of Youth-onset Type 2 Diabetes Clinical Centers (U01 Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.847.
• This funding opportunity was created on 2021-07-14.
• Applicants must submit their applications by 2022-03-03. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

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