Opportunity Information: Apply for RFA DK 09 012
Apply for RFA DK 09 012
- The National Institutes of Health in the food and nutrition health sector is offering a public funding opportunity titled "Pilot Studies for Studying the Mechanisms of Improvement in Type 2 Diabetes and Cardiovascular Risk Factors or in Cardiovascular, Lung, or Sleep Diseases after Bariatric Surgery (R01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.233 National Center on Sleep Disorders Research 93.837 Cardiovascular Diseases Research 93.838 Lung Diseases Research 93.847 Diabetes, Digestive, and Kidney Diseases Extramural Research.
- This funding opportunity was created on Aug 14, 2009 and posted on Aug 14, 2009.
- Applicants must submit their applications by Nov 19, 2009. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $400,000.00 in funding.
- Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification) Native American tribal governments (Federally recognized) State governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts County governments Small businesses Public and State controlled institutions of higher education Private institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Public housing authorities/Indian housing authorities For profit organizations other than small businesses Special district governments City or township governments.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Eligible Agencies of the Federal Government Faith based or Community based Organizations Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession.
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Opportunity Summary:
This NIH funding opportunity (RFA-DK-09-012) supports R01 research projects that lay the groundwork for a future, full-scale randomized clinical trial testing how bariatric surgery affects disease outcomes and underlying biological mechanisms. It is jointly issued by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the National Heart, Lung, and Blood Institute (NHLBI). The central idea is not to run a definitive large trial right away, but to figure out what the best trial should look like and to generate the pilot evidence needed to justify and successfully execute that larger study. Projects are expected to help clarify the mechanisms behind improvements seen after bariatric surgery, while also addressing the practical realities of recruiting participants, delivering the intervention, measuring outcomes, and maintaining follow-up in a randomized design.
The FOA is focused on adults with body mass index (BMI) between 30 and 40, which is a key constraint shaping the target population. Within that BMI range, applicants can propose studies centered on (1) type 2 diabetes and related cardiovascular risk factors in people who already have type 2 diabetes, or (2) cardiovascular, lung, or sleep diseases (for example, conditions in the cardiopulmonary or sleep-disordered breathing space) in affected individuals. The emphasis on mechanisms signals that applications should go beyond simply tracking clinical outcomes and should also include measurements that can explain why and how bariatric surgery leads to changes in glycemic control, cardiometabolic risk, or cardiopulmonary and sleep-related endpoints. At the same time, the announcement explicitly prioritizes feasibility and implementation data for a randomized clinical trial, meaning that proposed work should produce actionable information about trial procedures, adherence, retention, safety monitoring, and the logistics of surgical and comparison arms.
Funding is provided under the NIH Research Project Grant (R01) mechanism. The listed award ceiling is $400,000. Cost sharing or matching is not required. In terms of anticipated investment and award counts, NIDDK expected to support roughly 3 to 4 awards focused on diabetes-related topics, with total costs up to $2 million per year across those awards for up to 3 years. NHLBI anticipated supporting approximately 2 to 3 awards focused on cardiovascular, lung, or sleep disorder topics. As with typical NIH language, final numbers depend on both the volume of submissions and the scientific merit of the applications reviewed.
Eligibility is broad and includes many organizational types: public and private institutions of higher education, nonprofits (including both 501(c)(3) and certain non-501(c)(3) organizations), state and local governments, tribal governments and tribal organizations, independent school districts, public housing authorities/Indian housing authorities, for-profit organizations (including small businesses and other for-profits), special district governments, and city/township and county governments. The FOA also calls out additional eligible applicants such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribal Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions. In practice, this means the competition is open to a wide range of research-performing institutions capable of conducting pilot clinical trial work involving bariatric surgery and detailed phenotyping.
Key administrative details place this opportunity in 2009: it was posted and created on August 14, 2009, with an original (and current) closing date of November 19, 2009, and an archive date of December 20, 2009. It is categorized as discretionary funding, uses the grant instrument, and is associated with multiple CFDA numbers reflecting the participating NIH program areas, including diabetes and digestive and kidney diseases research, cardiovascular diseases research, lung diseases research, and the National Center on Sleep Disorders Research. The full announcement was available through the NIH Grants Guide (link provided in the listing), and technical access issues were routed to the NIH Office of Extramural Research webmaster.
Frequently Asked Questions (FAQ)
What is the funding opportunity number for this NIH grant?
The NIH funding opportunity is RFA-DK-09-012.
What is the overall purpose of this funding opportunity?
This opportunity supports R01 research projects designed to lay the groundwork for a future, full-scale randomized clinical trial (RCT) testing how bariatric surgery affects disease outcomes and the underlying biological mechanisms. The focus is on generating pilot evidence and practical trial-design information, rather than immediately launching a definitive large RCT.
Which NIH institutes are issuing this funding opportunity?
It is jointly issued by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the National Heart, Lung, and Blood Institute (NHLBI).
What type of grant mechanism is used?
Funding is provided under the NIH Research Project Grant (R01) mechanism.
Is this meant to fund a definitive, large randomized clinical trial right away?
No. The central idea is to determine what the best future full-scale randomized clinical trial should look like and to produce the pilot and feasibility evidence needed to justify and execute that larger study successfully.
What kinds of studies are encouraged under this FOA?
Studies are expected to address both (1) biological mechanisms behind improvements seen after bariatric surgery and (2) feasibility and implementation information needed for a randomized design, including recruitment, intervention delivery, outcome measurement, and follow-up procedures.
What population is this FOA focused on?
The FOA is focused on adults with body mass index (BMI) between 30 and 40.
What BMI range is required for participants?
Participants are expected to be adults with BMI between 30 and 40, which is a key constraint shaping the target population.
What disease focus areas are allowed within the BMI 30 to 40 population?
Applicants can propose studies centered on either: (1) type 2 diabetes and related cardiovascular risk factors in people who already have type 2 diabetes; or (2) cardiovascular, lung, or sleep diseases (including cardiopulmonary conditions or sleep-disordered breathing) in affected individuals.
Does the FOA prioritize mechanistic research, clinical outcomes, or both?
Both. The announcement emphasizes mechanisms, meaning applications should include measurements that can explain why and how bariatric surgery leads to changes in glycemic control, cardiometabolic risk, or cardiopulmonary and sleep-related endpoints. It also prioritizes feasibility and implementation data necessary for a future randomized clinical trial.
What does “mechanisms” mean in the context of this FOA?
Within this FOA, “mechanisms” refers to biological measurements and analyses that help explain the underlying processes responsible for improvements observed after bariatric surgery, not just whether clinical outcomes changed.
What does “feasibility and implementation data” mean for this FOA?
It refers to generating actionable information needed to run a randomized clinical trial, such as procedures for recruitment, adherence, retention, safety monitoring, and the logistics of implementing surgical and comparison arms and maintaining follow-up.
Does this FOA require a randomized design?
The FOA is explicitly oriented toward preparing for a future full-scale randomized clinical trial and prioritizes feasibility for a randomized design, including practical realities of running surgical and comparison arms and maintaining follow-up.
What is the maximum award amount listed?
The listed award ceiling is $400,000.
Is cost sharing or matching required?
No. Cost sharing or matching is not required.
How many awards were anticipated?
NIDDK expected to support roughly 3 to 4 awards focused on diabetes-related topics. NHLBI anticipated supporting approximately 2 to 3 awards focused on cardiovascular, lung, or sleep disorder topics. Final numbers depend on the volume of submissions and the scientific merit of applications.
What was the anticipated funding level and project period described for NIDDK?
NIDDK anticipated total costs up to $2 million per year across its diabetes-focused awards, for up to 3 years, depending on application volume and scientific merit.
Which topics were expected to be supported by NIDDK versus NHLBI?
NIDDK expected to support awards focused on type 2 diabetes and related cardiovascular risk factors in people with type 2 diabetes. NHLBI anticipated supporting awards focused on cardiovascular, lung, or sleep disorder topics.
What types of organizations are eligible to apply?
Eligibility is broad and includes public and private institutions of higher education, nonprofits (including 501(c)(3) and certain non-501(c)(3) organizations), state and local governments, tribal governments and tribal organizations, independent school districts, public housing authorities/Indian housing authorities, for-profit organizations (including small businesses and other for-profits), special district governments, and city/township and county governments.
Are minority-serving institutions and community-based organizations eligible?
Yes. The FOA specifically calls out additional eligible applicants such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribal Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions.
Is this opportunity limited to academic institutions?
No. The eligibility list includes many organization types, including for-profit organizations, government entities, nonprofits, and other research-performing institutions capable of conducting pilot clinical trial work involving bariatric surgery.
What is the posted/created date for this opportunity?
It was posted and created on August 14, 2009.
What is the application closing date listed?
The original (and current) closing date listed is November 19, 2009.
When was the opportunity archived?
The archive date is December 20, 2009.
What type of funding is this categorized as?
It is categorized as discretionary funding and uses the grant instrument.
Are CFDA program areas associated with this FOA?
Yes. It is associated with multiple CFDA numbers reflecting participating NIH program areas, including diabetes and digestive and kidney diseases research, cardiovascular diseases research, lung diseases research, and the National Center on Sleep Disorders Research.
Where was the full announcement made available?
The full announcement was available through the NIH Grants Guide (a link was provided in the listing).
Where are technical access issues directed?
Technical access issues were routed to the NIH Office of Extramural Research webmaster.
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