Opportunity Information: Apply for RFA DK 15 503

  • The National Institutes of Health in the food and nutrition health sector is offering a public funding opportunity titled "Limited Competition for the Continuation of the Diabetes Prevention Program Outcomes Study (DPPOS) Clinical Centers (Collaborative U01)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.847 Diabetes, Digestive, and Kidney Diseases Extramural Research.
  • This funding opportunity was created on Feb 6, 2015 and posted on Feb 6, 2015.
  • Applicants must submit their applications by Apr 9, 2015. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • The funding agency has allocated a total of $10,000,000.00 to eligible and selected applicants.
  • The number of recipients for this funding is limited to 21 candidate(s).
  • Eligible applicants include: Public and State controlled institutions of higher education Private institutions of higher education.
  • Other Eligible Applicants include the following This FOA is limited to the current awardees of the Diabetes Prevention Program Outcomes Study (DPPOS) Clinical Centers.
Apply for RFA DK 15 503

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Opportunity Summary:

This funding opportunity, RFA-DK-15-503, is a limited-competition NIH cooperative agreement (Collaborative U01) designed to continue long-term follow-up of participants in the Diabetes Prevention Program Outcomes Study (DPPOS). The core aim is to keep the DPPOS clinical centers operating so they can maintain contact with the established cohort, collect ongoing clinical and outcomes data, and extend the scientific value of one of the most influential diabetes prevention studies ever conducted. The announcement sits in the “Food and Nutrition/Health” activity area and is administered under CFDA 93.847 (Diabetes, Digestive, and Kidney Diseases Extramural Research).

The scientific rationale builds directly on the earlier Diabetes Prevention Program (DPP), a large multi-center randomized controlled trial that tested whether intensive lifestyle intervention or metformin could prevent or delay type 2 diabetes in people at high risk. The DPP produced landmark results: lifestyle change reduced diabetes incidence by about 58% and metformin reduced it by about 31%, compared to placebo. After the original trial concluded, participants transitioned into DPPOS so investigators could evaluate whether those early interventions produced durable benefits over time, including effects on later diabetes progression and the emergence of microvascular complications.

In this continuation phase, the FOA focuses the next stage of DPPOS follow-up on outcomes that become increasingly important as the cohort ages, particularly cardiovascular disease and cancer. A central question is the long-term effectiveness of early metformin exposure: whether initiating metformin during the prediabetes stage has measurable downstream effects on major clinical endpoints beyond diabetes itself. By supporting the clinical centers, NIH is essentially funding the infrastructure and coordinated effort needed to keep the cohort engaged, ensure standardized data collection, and capture clinical events reliably across sites so that long-term risk and benefit profiles can be assessed with confidence.

Because this is a cooperative agreement (U01), NIH expects substantial involvement in the conduct and coordination of the work rather than a hands-off grants model. The “collaborative” framing also signals that the clinical centers will operate as a network, using common protocols and shared governance to support consistent follow-up, adjudication of outcomes where applicable, and high-quality longitudinal data. The announcement also notes a companion funding opportunity, RFA-DK-15-505, which supports the continuation of the DPPOS Biostatistics Research Center, highlighting that the clinical sites and the statistical/data coordinating functions are intended to work together as an integrated program.

The competition is explicitly limited: only the current awardees of the DPPOS Clinical Centers are eligible to apply. Eligible organization types listed include public and state-controlled institutions of higher education and private institutions of higher education, but the key eligibility constraint is prior DPPOS Clinical Center award status. This limitation reflects the practical reality that continued follow-up of an established cohort relies heavily on existing site relationships, staff expertise, established procedures, and continuity of operations.

From an administrative standpoint, the FOA was posted on February 6, 2015, with an original and current closing date of April 9, 2015, and an archive date of May 10, 2015. NIH anticipated up to 21 awards under this announcement, with an estimated total funding level of $10,000,000 and no cost-sharing or matching requirement. The full announcement was made available through the NIH grants guide, and NIH provided standard contact pathways through the NIH Office of Extramural Research (OER) webmaster for access or linking issues.

Overall, the opportunity is best understood as a continuation mechanism to preserve and expand the long-term public health value of the DPP/DPPOS investment. Instead of launching a new cohort or a new trial from scratch, NIH is extending follow-up on a uniquely well-characterized population to answer higher-order questions about whether early diabetes-preventive strategies, especially metformin, translate into fewer major chronic disease events like cardiovascular outcomes and cancer over the long run.

Frequently Asked Questions (FAQs)

What is the funding opportunity number and title?

The opportunity is NIH RFA-DK-15-503. It is a limited-competition NIH cooperative agreement (Collaborative U01) to continue long-term follow-up of participants in the Diabetes Prevention Program Outcomes Study (DPPOS) by supporting the ongoing operation of the DPPOS Clinical Centers.

What is the main purpose of this FOA?

The central purpose is to keep the DPPOS clinical centers operating so they can maintain contact with the established cohort, collect ongoing clinical and outcomes data, and extend the scientific value of the Diabetes Prevention Program (DPP) and DPPOS through continued long-term follow-up.

What is DPP and how does it relate to DPPOS?

The Diabetes Prevention Program (DPP) was a large multi-center randomized controlled trial that tested whether intensive lifestyle intervention or metformin could prevent or delay type 2 diabetes in people at high risk. After the original trial concluded, participants transitioned into the Diabetes Prevention Program Outcomes Study (DPPOS) so investigators could evaluate whether early interventions produced durable long-term benefits, including effects on diabetes progression and microvascular complications.

What were the landmark results from the original DPP trial mentioned in the FOA summary?

The DPP produced major findings: intensive lifestyle change reduced diabetes incidence by about 58% and metformin reduced it by about 31%, compared to placebo.

What outcomes are emphasized in this continuation phase of DPPOS?

This continuation phase focuses on outcomes that become increasingly important as the cohort ages, particularly cardiovascular disease and cancer, while continuing the broader long-term follow-up of the established DPPOS cohort.

What key scientific question does the FOA highlight about metformin?

A central question is the long-term effectiveness of early metformin exposure, specifically whether initiating metformin during the prediabetes stage has measurable downstream effects on major clinical endpoints beyond diabetes itself.

Why is NIH funding the clinical centers rather than starting a new cohort or trial?

The FOA is designed as a continuation mechanism to preserve and expand the long-term public health value of the DPP/DPPOS investment. Instead of launching a new cohort or trial from scratch, NIH is extending follow-up on a uniquely well-characterized population to assess long-term risk and benefit profiles with confidence.

What does it mean that this is a cooperative agreement (U01)?

As a cooperative agreement (U01), NIH expects substantial involvement in the conduct and coordination of the work rather than a purely hands-off grants model. The “collaborative” framing indicates the clinical centers will operate as a network using common protocols and shared governance to support consistent follow-up and high-quality longitudinal data.

How are the DPPOS Clinical Centers expected to work together?

The clinical centers are expected to function as a coordinated network with common protocols and shared governance, supporting standardized data collection and reliable capture of clinical events across sites.

Is there a related or companion funding opportunity?

Yes. The FOA notes a companion opportunity, RFA-DK-15-505, which supports the continuation of the DPPOS Biostatistics Research Center. This signals that the clinical sites and the statistical/data coordinating functions are intended to work together as an integrated program.

What activity area does this funding opportunity fall under?

The announcement is in the “Food and Nutrition/Health” activity area.

What CFDA number is associated with this opportunity?

This opportunity is administered under CFDA 93.847, titled “Diabetes, Digestive, and Kidney Diseases Extramural Research.”

Who is eligible to apply?

The competition is explicitly limited: only the current awardees of the DPPOS Clinical Centers are eligible to apply.

Are universities eligible to apply?

Eligible organization types listed include public and state-controlled institutions of higher education and private institutions of higher education, but eligibility is constrained to organizations that are current DPPOS Clinical Center awardees.

Why is the competition limited to current DPPOS Clinical Center awardees?

The limitation reflects the practical reality that continued follow-up of an established cohort relies heavily on existing site relationships, staff expertise, established procedures, and continuity of operations.

How many awards did NIH anticipate making under this announcement?

NIH anticipated up to 21 awards under this FOA.

What is the estimated total funding level?

The estimated total funding level for the announcement is $10,000,000.

Is cost sharing or matching required?

No. The FOA states there is no cost-sharing or matching requirement.

When was the FOA posted and what were the key dates?

The FOA was posted on February 6, 2015. The original and current closing date was April 9, 2015, and the archive date was May 10, 2015.

Where was the full announcement made available?

The full announcement was made available through the NIH grants guide.

Who is listed as a contact for access or linking issues?

NIH provided standard contact pathways through the NIH Office of Extramural Research (OER) webmaster for access or linking issues.

What types of work are the clinical centers being supported to do?

The FOA supports the infrastructure and coordinated effort needed to keep the cohort engaged, maintain contact with participants, ensure standardized collection of ongoing clinical and outcomes data, and capture clinical events reliably across sites to enable confident long-term assessment.

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Limited Competition for the Continuation of Look AHEAD (Action for Health in Diabetes) Biostatistics Research Center (Collaborative U01) Apply for RFA DK 15 502

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