Diabetes, Digestive, and Kidney Diseases Extramural Research

 

(1) To promote extramural basic and clinical biomedical research that improves the understanding of the mechanisms underlying disease and leads to improved preventions, diagnosis, and treatment of diabetes, digestive, and kidney diseases. Programmatic areas within the National Institute of Diabetes and Digestive and Kidney Diseases include diabetes, digestive, endocrine, hematologic, liver, metabolic, nephrologic, nutrition, obesity, and urologic diseases. Specific programs areas of interest include the following: (a) For diabetes, endocrine, and metabolic diseases areas: Fundamental and clinical studies including the etiology, pathogenesis, prevention, diagnosis, treatment and cure of diabetes mellitus and its complications; Normal and abnormal function of the pituitary, thyroid, parathyroid, adrenal, and other hormone secreting glands; Hormonal regulation of bone, adipose tissue, and liver; on fundamental aspects of signal transduction, including the action of hormones, coregulators, and chromatin remodeling proteins; Hormone biosynthesis, secretion, metabolism, and binding; and on hormonal regulation of gene expression and the role(s) of selective receptor modulators as partial agonists or antagonists of hormone action; and Fundamental studies relevant to metabolic disorders including membrane structure, function, and transport phenomena and enzyme biosynthesis; and basic and clinical studies on the etiology, pathogenesis, prevention, and treatment of inherited metabolic disorders (such as cystic fibrosis). (b) For digestive disease and nutrition areas: Genetics and genomics of the GI tract and its diseases; Genetics and genomics of liver/pancreas and diseases; Genetics and genomics of nutrition; genetics and genomics of obesity; Bariatric surgery; Clinical nutrition research; Clinical obesity research; Complications of chronic liver disease; Fatty liver disease; Genetic liver disease; HIV and liver; Cell injury, repair, fibrosis and inflammation in the liver; Liver cancer; Liver transplantation; Pediatric liver disease; Viral hepatitis and infectious diseases; Gastrointestinal and nutrition effects of AIDS; Gastrointestinal mucosal and immunology; Gastrointestinal motility; Basic neurogastroenterology; Gastrointestinal development; Gastrointestinal epithelial biology; Gastrointestinal inflammation; Digestive diseases epidemiology and data systems; Nutritional epidemiology and data systems; Autoimmune liver disease; Bile, Bilirubin and cholestasis; Bioengineering and biotechnology related to digestive diseases, liver, nutrition and obesity; Cell and molecular biology of the liver; Developmental biology and regeneration; Drug-induced liver disease; Gallbladder disease and biliary diseases; Exocrine pancreas biology and diseases; Gastrointestinal neuroendocrinology; Gastrointestinal transport and absorption; Nutrient metabolism; Pediatric clinical obesity; Clinical trials in digestive diseases; Liver clinical trials; Obesity prevention and treatment; and Obesity and eating disorders. (c) For kidney, urologic and hematologic diseases areas: Studies of the development, physiology, and cell biology of the kidney; Pathophysiology of the kidney; Genetics of kidney disorders; Immune mechanisms of kidney disease; Kidney disease as a complication of diabetes; Effects of drugs, nephrotoxins and environmental toxins on the kidney; Mechanisms of kidney injury repair; Improved diagnosis, prevention and treatment of chronic kidney disease and end-stage renal disease; Improved approaches to maintenance dialysis therapies; Basic studies of lower urinary tract cell biology, development, physiology, and pathophysiology; Clinical studies of bladder dysfunction, incontinence, pyelonephritis, interstitial cystitis, benign prostatic hyperplasia, urolithiasis, and vesicoureteral reflux; Development of novel diagnostic tools and improved therapies, including tissue engineering strategies, for urologic disorders;Research on hematopoietic cell differentiation; metabolism of iron overload and deficiency; Structure, biosynthesis and genetic regulation of hemoglobin; as well as Research on the etiology, pathogenesis, and therapeutic modalities for the anemia of inflammation and chronic diseases.
(2) To encourage basic and clinical research training and career development of scientists during the early stages of their careers. The Ruth L. Kirschstein National Research Service Award (NRSA) funds basic and clinical research training, support for career development, and the transition from postdoctoral biomedical research training to independent research related to diabetes, digestive, endocrine, hematologic, liver, metabolic, nephrologic, nutrition, obesity, and urologic diseases. (3) To expand and improve the Small Business Innovation Research (SBIR) program. The SBIR Program aims to increase and facilitate private sector commercialization of innovations derived from Federal research and development; to enhance small business participation in Federal research and development; and to foster and encourage participation of socially and economically disadvantaged small business concerns and women-owned small business concerns in technological innovation. (4) To utilize the Small Business Technology Transfer (STTR) program. The STTR Program intends to stimulate and foster scientific and technological innovation through cooperative research and development carried out between small business concerns and research institutions; to foster technology transfer between small business concerns and research institutions; to increase private sector commercialization of innovations derived from Federal research and development; and to foster and encourage participation of socially and economically disadvantaged small business concerns and women-owned small business concerns in technological innovation.

General information about this opportunity
Last Known Status
Active
Program Number
93.847
Federal Agency/Office
Agency: Department of Health and Human Services
Office: National Institutes of Health
Type(s) of Assistance Offered
PROJECT GRANTS
Program Accomplishments
Fiscal Year 2014: Project Grants: $1,427,210,000 with 3,175 awards
NRSA: $55,781,240 with 449 awards and 1,094 FTTPs/trainees
SBIR/STTR: $51,850,000 with 116 awards. Fiscal Year 2015: Project Grants: $1,448,701,000 with 3,177 awards are estimated
NRSA: $56,635,900 with 449 awards and 1,094 FTTPs/trainees are estimated
SBIR/STTR: $55,816,000 with 126 awards are estimated. Fiscal Year 2016: Project Grants: $1,473,133,000 with 3,235 awards are estimated
NRSAs: $57,212,240 with 472 awards and 1,117 FTTPs/trainees are estimated
SBIR: $57,877,000 with 131 awards are estimated.
Authorization
Public Health Service Act, Sections 301, 405, 428, 431, 487, 491, 493, 495, and 498, as amended; Public Laws 78-410, 99- 158, 100-607, 106-554, and 107-360; 42 U.S.C. 241, as amended; 42 U.S.C. 285c-2, 42 U.S.C. 285c-5, 42 U.S.C. 288; Small Business Research and Development Enhancement Act of 1992, Public Law 102-564.
Who is eligible to apply/benefit from this assistance?
Applicant Eligibility
Project Grants: Universities, colleges, medical, dental and nursing schools, schools of public health, laboratories, hospitals, State and local health departments, other public or private institutions, both non-profit and for-profit, and individuals who propose to establish, expand, and improve research activities in health sciences and related fields. NRSAs: Support is provided for academic and research training only, in health and health-related areas that are periodically specified by the National Institutes of Health. To be eligible, predoctoral awardees must have completed the baccalaureate degree and postdoctoral awardees must have a professional or scientific degree (M.D., Ph.D., D.D.S., D.O., D.V.M., Sc.D., D.Eng., or equivalent domestic or foreign degree). Individuals must be nominated and sponsored by a public or nonprofit private institution having staff and facilities appropriate to the proposed research training program. All awardees must be citizens or have been admitted to the United States for permanent residence. Nonprofit domestic organizations may apply for the Institutional NRSA. SBIR and STTR grants can be awarded only to domestic small businesses that meet the following criteria: 1) Is independently owned and operated, is not dominant in the field of operation in which it is proposing, has a place of business in the United States and operates primarily within the United States or makes a significant contribution to the US economy, and is organized for profit; 2) Is (a) at least 51% owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States, or (b) for SBIR only, it must be a for-profit business concern that is at least 51% owned and controlled by another for-profit business concern that is at least 51% owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States. 3) Has, including its affiliates, an average number of employees for the preceding 12 months not exceeding 500, and meets the other regulatory requirements found in 13 C.F.R. Part 121. Business concerns are generally considered to be affiliates of one another when either directly or indirectly, (a) one concern controls or has the power to control the other; or (b) a third-party/parties controls or has the power to control both. STTR grants which "partner" with a research institution in cooperative research and development. At least 40 percent of the project is to be performed by the small business concern and at least 30 percent by the research institution. In both Phase I and Phase II, the research must be performed in the U.S. and its possessions. To be eligible for funding, a grant application must be approved for scientific merit and program relevance by a scientific review group and a national advisory council.
Beneficiary Eligibility
Health professionals, graduate students, health professional students, scientists, and researchers, any nonprofit or for-profit organization, company, or institution engaged in biomedical research. Project Grants: Although no degree of education is either specified or required, nearly all successful applicants have doctoral degrees in one of the sciences or professions. NRSAs: Predoctoral awardees must have completed the baccalaureate degree and postdoctoral awardees must have a professional or scientific degree.
Credentials/Documentation
Each applicant for research projects must present a research plan and furnish evidence that scientific competence, facilities, equipment, and supplies are appropriate to carry out the plan. For SBIR and STTR grants, applicant organization (small business concern) must present in a research plan an idea that has potential for commercialization and furnish evidence that scientific competence, experimental methods, facilities, equipment, and funds requested are appropriate to carry out the plan. Individual NRSA applications for postdoctoral training must include the candidate's academic record, research experience, citizenship, institutional sponsorship, and the proposed area and plan of training. Institutional Training grant applications for predoctoral and postdoctoral training must show the objectives, methodology and resources for the research training program; the qualifications and experience of directing staff; the criteria to be used in selecting individuals for stipend support; and a detailed budget and justification for the amount of grant funds requested. For-profit organizations' costs are determined in accordance with Subpart 31.2 of the Federal Acquisition Regulations. For other grantees, costs will be determined in accordance with HHS Regulations 45 CFR, Part 75, Subpart Q. For SBIR and STTR grants, applicant organization (small business concern) must present in a research plan an idea that has potential for commercialization and furnish evidence that scientific competence, experimental methods, facilities, equipment, and funds requested are appropriate to carry out the plan. Grant form PHS 398 is used to apply for SBIR and STTR Phase I Phase II and Phase I/Phase II Fast Track. 2 CFR 200, Subpart E - Cost Principles applies to this program.
What is the process for applying and being award this assistance?
Pre-Application Procedure
Preapplication coordination is not applicable. Environmental impact information is not required for this program. This program is excluded from coverage under E.O. 12372.
Application Procedure
This program is excluded from coverage under 2 CFR 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards. Project Grants: Applications for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide. Applications may not be submitted in paper format. A registration process through Grants.gov is necessary before submission and applicants are highly encouraged to start the process at least four weeks prior to the grant submission date. Two steps are required for on time submission: (1) The application must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the submission/receipt date. (2) Applicants must complete a verification step in the eRA Commons within two business days of notification from NIH. Note: Since email can be unreliable, it is the responsibility of the applicant to periodically check on their application status in the Commons. The standard application forms, as furnished by PHS and required by 45 CFR Part 92, must be used for this program by those applicants that are State or local units of government. SBIR and STTR Grant Solicitations and SBIR Contract Solicitation may be obtained electronically through the NIH's "Small Business Funding Opportunities" home page at www.nih.gov/grants/funding/sbir.htm on the World Wide Web. The Solicitations include submission procedures, review considerations, and grant application or contract proposal forms.
Award Procedure
Research Grant and Training Program applications are reviewed initially for scientific merit by an appropriate review panel, composed of scientific authorities, and by the National Diabetes and Digestive and Kidney Diseases Advisory Council composed of leaders in medical science, education, and public affairs. Approved applications will compete on a merit basis for available funds. The successful applicant is sent a Notice of Grant Award. All accepted SBIR/STTR applications are evaluated for scientific and technical merit by an appropriate scientific peer review panel and by a national advisory council or board. All applications receiving a priority score compete for available SBIR/STTR set-aside funds on the basis of scientific and technical merit and commercial potential of the proposed research, program relevance, and program balance among the areas of research.
Deadlines
Contact the headquarters or regional office, as appropriate, for application deadlines.
Approval/Disapproval Decision Time
Project Grants: From 6 to 9 months. National Research Service Awards: From 6 to 9 months. SBIR/STTR applications: About 7-1/2 months.
Appeals
A principal investigator (P.I.) may question the substantive or procedural aspects of the review of his/her application by communicating with the staff of the Institute. A description of the NIH Peer Review Appeal procedures is available on the NIH home page http://grants.nih.gov/grants/guide/notice-files/not97-232.html.
Renewals
Project Grants: Renewals are determined by competitive application and review. Extensions considered upon request. Individual NRSAs: Awards may be made for 1, 2, or 3 years. No individual may receive NIH fellowship support at the postdoctoral level for more than 3 years.
How are proposals selected?
The major elements in evaluating proposals include assessments of: (1) The scientific merit and general significance of the proposed study and its objectives; (2) the technical adequacy of the experimental design and approach; (3) the competency of the proposed investigator or group to successfully pursue the project; (4) the adequacy of the available and proposed facilities and resources; (5) the necessity of the budget components requested in relation to the proposed project; and (6) the relevance and importance to announced program objectives. The following criteria will be used in considering the scientific and technical merit of SBIR/STTR Phase I grant applications: (1) The soundness and technical merit of the proposed approach; (2) the qualifications of the proposed principal investigator, supporting staff, and consultants; (3) the technological innovation of the proposed research; (4) the potential of the proposed research for commercial application; (5) the appropriateness of the budget requested; (6) the adequacy and suitability of the facilities and research environment; and (7) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or animal subjects, and/or (b) protecting against or minimizing any adverse effect on the environment. Phase II grant applications will be reviewed based upon the following criteria: (1) The degree to which the Phase I objectives were met and feasibility demonstrated; (2) the scientific and technical merit of the proposed approach for achieving the Phase II objectives; (3) the qualifications of the proposed principal investigator, supporting staff, and consultants; (4) the technological innovation, originality, or societal importance of the proposed research; (5) the potential of the proposed research for commercial application; (6) the reasonableness of the budget requested for the work proposed; (7) the adequacy and suitability of the facilities and research environment; and (8) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or animal subjects, and/or (b) protecting against or minimizing any adverse effect on the environment.
How may assistance be used?
Project Grants provide funds for salaries, equipment, supplies, travel, and other expenses associated with scientific investigation relevant to program objectives. NRSAs are made directly to individuals for research training in specified biomedical shortage areas, or, to institutions to enable them to make NRSAs to individuals selected by them. Each individual who receives a NRSA is obligated upon termination of the award to comply with certain service and payback provisions. SBIR Phase I grants (of approximately 6-months duration) are to establish the technical merit and feasibility of a proposed research effort that may lead to a commercial product or process. Phase II grants are for the continuation of the research initiated in Phase I and that are likely to result in commercial products or processes. Only Phase I awardees are eligible to receive Phase II support. STTR Phase I grants (normally of 1-year duration) are to determine the scientific, technical, and commercial merit and feasibility of the proposed cooperative effort that has potential for commercial application. Phase II funding is based on results of research initiated in Phase I and scientific and technical merit and commercial potential of the Phase II application.
What are the requirements after being awarded this opportunity?
Reporting
Project Grants: Expenditures and other financial records, including documents supporting accounting records and substantive charges to each grant, must be retained for 3 years from the day on which the grantee submits the last expenditure report for the report period. NRSAs: Documentation of expenditures and other fiscal records must be kept readily available for examination by authorized Government personnel and must be retained for 3 years from the day on which the grantee submits the last expenditure report for the report period. Reports are required after termination of NRSAs to ascertain compliance with service and payback provisions. Cash reports are not applicable. Annual and terminal progress reports, annual reports of inventions, and annual certification with respect to research involving human subjects are required. Reports of expenditures are required. NRSAs: Reports are required after termination of NRSAs to ascertain compliance with service and payback provisions. Performance monitoring is not applicable.
Auditing
In accordance with the provisions of 2 CFR 200, Subpart F - Audit Requirements, non-Federal entities that expend financial assistance of $750,000 or more in Federal awards will have a single or a program-specific audit conducted for that year. Non-Federal entities that expend less than $750,000 a year in Federal awards are exempt from Federal audit requirements for that year, except as noted in 2 CFR 200.503. Records must be available for review or audit by appropriate officials of the Federal agency, pass-through entity, and Government Accountability Office (GAO). Foreign grantees are subject to the same audit requirements as for-profit (commercial) organizations.
Records
Grantees generally must retain financial and programmatic records, supporting documents, statistical records, and all other records that are required by the terms of a grant, or may reasonably be considered pertinent to a grant, for a period of 3 years from the date the annual FSR is submitted. For awards under SNAP (other than those to foreign organizations and Federal institutions), the 3-year retention period will be calculated from the date the FSR for the entire competitive segment is submitted. Those grantees must retain the records pertinent to the entire competitive segment for 3 years from the date the FSR is submitted to NIH. Foreign organizations and Federal institutions must retain records for 3 years from the date of submission of the annual FSR to NIH. See 45 CFR 74.53 and 92.42 for exceptions and qualifications to the 3-year retention requirement (e.g., if any litigation, claim, financial management review, or audit is started before the expiration of the 3-year period, the records must be retained until all litigation, claims, or audit findings involving the records have been resolved and final action taken). Those sections also specify the retention period for other types of grant-related records, including F&A cost proposals and property records. See 45 CFR 74.48 and 92.36 for record retention and access requirements for contracts under grants. In accordance with 45 Code of Federal Regulations, Part 74.53(e), the HHS Inspector General, the U.S. Comptroller General, or any of their duly authorized representatives have the right of timely and unrestricted access to any books, documents, papers, or other records of recipients that are pertinent to awards in order to make audits, examinations, excerpts, transcripts, and copies of such documents. This right also includes timely and reasonable access to a recipient’s personnel for the purpose of interview and discussion related to such documents. The rights of access are not limited to the required retention period, but shall last as long as records are retained.
Other Assistance Considerations
Formula and Matching Requirements
This program has no statutory formula.
Matching requirements are not applicable to this program.
MOE requirements are not applicable to this program.
Length and Time Phasing of Assistance
Project Grants: Awards are usually made for a 12-month period with recommendation of up to 4 years of additional support. SBIR: Normally, Phase I awards are for 6 months; normally, Phase II awards are for 2 years. STTR: Normally, Phase I awards are for 1 year; normally, Phase II awards are for 2 years. See the following for information on how assistance is awarded/released: The Notice of Award (NoA) is the legal document issued to notify the grantee that an award has been made and that funds may be requested from the designated HHS payment system or office. An NoA is issued for the initial budget period. If subsequent budget periods are also approved, the NoA will include a reference to those budgetary commitments. Funding for subsequent budget periods are generally provided in annual increments following the annual assessment of progress. This funding is also contingent on the availability of funds. The NoA includes all applicable terms of award either by reference or specific statements. It provides contact information for the assigned program officer and grants management specialist. The grantee accepts an NIH award and its associated terms and conditions by drawing or requesting funds from the Payment Management System, or upon the endorsement of a check from the US Treasury for foreign awardees.
Who do I contact about this opportunity?
Regional or Local Office
None. Project Grants: Dr. Judith Fradkin, Director, Division of Diabetes, Endocrinology, and Metabolic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, 2 Democracy Plaza, Room 689, 6707 Democracy Blvd., Bethesda, MD 20892-2560. Telephone: (301) 496-7349; Dr. Stephen James, Director, Division of Digestive Diseases and Nutrition, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, 2 Democracy Plaza, Room 675, 6707 Democracy Blvd., Telephone: (301) 594-7680; Dr. Robert Star, Director, Division of Kidney, Urologic and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, 2 Democracy Plaza, Room 625, 6707 Democracy Blvd., Bethesda, MD 20892-2560. Telephone: (301) 594-7717. Small Business Innovation Research Grants Contact: Mrs. Helen Ling, Senior Grants Management Specialist, Grants Management Branch, Division of Extramural Activities, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, 2 Democracy Plaza, Room 732, 6707 Democracy Blvd., Bethesda, MD 20892. Telephone: (301) 594-8857. Grants Management Contact: Mr. Robert Pike, Chief Grants Management Officer, Grants Management Branch, Division of Extramural Activities, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, 2 Democracy Plaza, Room 731, 6707 Democracy Blvd., Bethesda, MD 20892. Telephone: (301) 594-8854. Use the same numbers for FTS.
Headquarters Office
Michelle Shorter 31 Center Drive, Room 9A34, Bethesda, Maryland 20892 Email: Shorterm@niddk.nih.gov Phone: 3015948842
Website Address
http://www2.niddk.nih.gov
Financial Information
Account Identification
75-0884-0-1-552.
Obligations
(Project Grants) FY 14 $1,534,841,240; FY 15 est $1,561,152,900; and FY 16 est $1,588,222,240 - The amounts above are the total Project Grants, NRSA and SBIR/STTR awards. The Project Grants and NRSA awards include Type 1 Diabetes funds and exclude TAPS. The SBIR/STTR awards include Type 1 Diabetes funds.
Range and Average of Financial Assistance
Project Grants: Range of $597 to $27,443,000; $450,000 average
NRSAs: Range of $3,955 to $652,000; $124,000 average
SBIR: Range of $7,000 to $1,655,000; $447,000 average.
Regulations, Guidelines and Literature
Project Grants: 42 CFR 52; 42 CFR 66; 42 CFR 74; 45 CFR 74; 45 CFR 92. Administration Policy Directive No. 65 01 (47 Fed. Reg. 52966 et seq. (1982), as amended by Policy Directive No. 65 01.1 (48 Fed. Reg. 38794 et seq. (1983)). Grants will be available under the authority of and administered in accordance with the NIH Grants Policy Statement, http://grants.nih.gov/grants/policy/nihgps_2003/; Omnibus Solicitation of the Public Health Service for SBIR Grant and Cooperative Agreement Applications. Omnibus Solicitation of the National Institutes of Health for STTR Grant Applications.
Examples of Funded Projects
Fiscal Year 2014: Division of Diabetes, Endocrinology and Metabolic Diseases Projects
Surgical vs Medical Treatments for Type 2 Diabetes Mellitus: A Randomized Clinical Trial. Courcoulas AP, Goodpaster BH, Eagleton JK , Belle SH, Kalarchian MA, Lang W, Toledo FG, Jakicic JM. JAMA Surg 149: 707-715, 2014; and
Roux-en-Y Gastric Bypass Surgery or Lifestyle With Intensive Medical Management in Patients With Type 2 Diabetes: Feasibility and 1-Year Results of a Randomized Clinical Trial. Halperin F, Ding SA, Simonson DC, Panosian J, Goebel-Fabbri A, Wewalka M, Hamdy O, Abrahamson M, Clancy K, Foster K, Lautz D, Vernon A, Goldfine AB. JAMA Surg 149: 716-726, 2014.
Bariatric Surgery in Adults with Type 2 Diabetes and Mild or Moderate Obesity: Two small clinical trials found that, after 1 year, bariatric surgery may be more effective than non-surgical approaches for treating type 2 diabetes in adults who have mild or moderate levels of obesity. Previous studies of bariatric surgery demonstrated benefits, at least in the short-term, for weight loss and ameliorating type 2 diabetes in individuals with extreme obesity or somewhat lower levels of obesity, but there has been only limited research in people with milder levels of obesity. In one of the recent clinical trials, researchers randomly assigned volunteers, all of whom had type 2 diabetes and mild to moderate obesity, to receive bariatric surgery (46 people) or an intensive lifestyle intervention of diet and exercise for weight loss (23 people). After 1 year, those assigned to receive Roux-en-Y gastric bypass surgery gained the most benefit: 50 percent experienced partial diabetes remission, and a few experienced complete remission (normal blood sugar levels without need for diabetes medication). Another surgical procedure, gastric banding, also led to partial or complete diabetes remission in some of the volunteers, but the lifestyle intervention did not. Similar results were observed in the other small clinical trial. A few individuals in each trial experienced complications. These studies add to knowledge of health outcomes from bariatric surgery and could inform future research on longer-term risks and benefits.

Endocrinization of FGF1 produces a neomorphic and potent insulin sensitizer. Suh JM, Jonker JW, Ahmadian M, Goetz R, Lackey D, Osborn O, Huang Z, Liu W, Yoshihara E, van Dijk TH, Havinga R, Fan W, Yin YQ, Yu RT, Liddle C, Atkins AR, Olefsky JM, Mohammadi M, Downes M, Evans RM. Nature 513: 436-439, 2014.
FGF1 as a Possible Novel Therapeutic for Type 2 Diabetes: A class of type 2 diabetes medications—thiazolidinediones—act as insulin sensitizers, but have significant side effects. Therefore, agents that improve insulin sensitivity without leading to unwanted side effects are desirable. This research study demonstrated that administration of a molecule—FGF1—into mice that were insulin-resistant, due to either diet or genetics, led to normalized blood glucose levels. FGF1 did not affect blood glucose levels in normal insulin-sensitive mice, and appeared to be acting as an insulin sensitizer, but without causing some side effects associated with approved insulin-sensitizing drugs. FGF1 may have potential as a new therapeutic for type 2 diabetes, if similar results are observed in human studies.

Division of Digestive Diseases and Nutrition Projects
Liver injury from herbals and dietary supplements in the U.S. Drug-Induced Liver Injury Network. Navarro VJ, Barnhart H, Bonkovsky HL, Davern T, Fontana RJ, Grant L, Reddy KR, Seeff LB, Serrano J, Sherker AH, Stolz A, Talwalkar J, Vega M, and Vuppalanchi R. Hepatology 60: 1399-1408, 2014.
Drug-Induced Liver Injury Network (DILIN): A study by Network researchers showed a dramatic increase in liver injury caused by some herbals and dietary supplements used across the United States in the past decade. An estimated half of all U.S. adults take herbals or dietary supplements. In a study conducted at eight U.S. medical centers in the DILIN over several years, persons with drug-induced liver injury from herbals and dietary supplements were compared to persons with drug-induced liver injury from conventional medications. Drug-induced liver injury from herbals and dietary supplements rose from 7 percent to 20 percent during the study period (2004 to 2013). Bodybuilding products were the leading herbals and dietary supplements causing liver injury, which took place mainly in young men. These men presented with a unique clinical picture of liver injury with jaundice lasting several months in some cases, as well as intense itching in many. Liver injury caused by the non-bodybuilding herbal and dietary supplements was more severe than that caused by the bodybuilding products or conventional medications, resulting in some cases in liver transplantation and even death. This form of herbal/dietary supplement-related liver injury was more common in middle-aged women taking supplements for weight loss or a boost in energy. Additional research is needed to identify components of some herbals and dietary supplements on the market that can cause liver injury in susceptible individuals.

Impact of intensive lifestyle intervention on depression and health-related quality of life in type 2 diabetes: the Look AHEAD Trial. Rubin RR, Wadden TA, Bahnson JL, Blackburn GL, Brancati FL, Bray GA, Coday M, Crow SJ, Curtis JM, Dutton G, Egan C, Evans M, Ewing L, Faulconbridge L, Foreyt J, Gaussoin SA, Gregg EW, Hazuda HP, Hill JO, Horton ES, Hubbard VS, Jakicic JM, Jeffery RW, Johnson KC, Kahn SE, Knowler WC, Lang W, Lewis CE, Montez MG, Murillo A, Nathan DM, Patricio J, Peters A, Pi-Sunyer X, Pownall H, Rejeski WJ, Rosenthal RH, Ruelas V, Toledo K, Van Dorsten B, Vitolins M, Williamson D, Wing RR, Yanovski SZ, Zhang P; Look AHEAD Research Group. Diabetes Care 37: 1544-1553, 2014.
Look AHEAD (Action for Health in Diabetes) Interventions and Depression: The long-term, multi-center Look AHEAD clinical trial sought to determine whether a lifestyle intervention can improve cardiovascular outcomes in overweight and obese persons with type 2 diabetes. At the same time, Look AHEAD researchers examined the impact of trial interventions on related conditions in participants. Depression is a common comorbidity of both type 2 diabetes and obesity. Look AHEAD researchers found that, compared to a diabetes support and education (DSE) intervention, an intensive lifestyle intervention (ILI) designed to produce weight loss protected non-depressed participants from incidence of mild or greater depression symptoms over 8 years of follow up, without concomitant differences in use of anti-depressant medications. Participants in the ILI group also consistently reported better physical function than those in the DSE group over the 8 years, although both groups experienced decline in this aspect of health related quality of life. These potential health benefits can now be considered by overweight and obese persons with type 2 diabetes and their health care providers when considering an intensive lifestyle treatment regimen.

Division of Kidney, Urologic and Hermatologic Diseases Projects
Improving the lens design and performance of a contemporary electromagnetic shock wave lithotripter. Neisius A, Smith NB, Sankin G, Kuntz NJ, Madden JF, Fovargue DE, Mitran S, Lipkin ME, Simmons WN, Preminger GM, Zhong P. Proc Natl Acad Sci USA 111: E1167-E1175, 2014.
Design Change May Improve Kidney Stone Treatment: New research has shown that changes to a medical machine called a lithotripter may improve kidney stone treatment. Kidney stones are one of the most common disorders of the urinary tract. One treatment option for a person with a large stone, or one that blocks urine flow and causes great pain, is non-invasive shock wave lithotripsy. In shock wave lithotripsy, the lithotripter generates shock waves that pass through the person’s body to break the kidney stone into smaller pieces to pass more readily through the urinary tract. Researchers have recently determined that the more powerful lithotripters shift the shock wave off-target, which contributes to efficiency loss. In addition, this same group of investigators made modifications to the lithotripter’s lens while keeping all other aspects of the device the same. By introducing a groove around the outer portion of the lens, the researchers were able to re-direct the shock wave to its proper target when tested in an animal model. The newly designed lithotripter pulverized 89 percent of the stones to sufficient size for passage through the urinary tract compared to 54 percent of the stones by the current generation of lithotripter. Moreover, it is anticipated that the newly designed lithotripter will cause less damage to surrounding tissue. If future research shows similar benefits in people with kidney stones, this newly designed lens may be adaptable by other manufacturers to improve their lithotripters currently in medical practice.

Apolipoprotein L1 gene variants associate with prevalent kidney but not prevalent cardiovascular disease in the Systolic Blood Pressure Intervention Trial. Langefeld CD, Divers J, Pajewski NM, Hawfield AT, Reboussin DM, Bild DE, Kaysen GA, Kimmel PL, Raj DS, Ricardo AC, Wright JT Jr, Sedor JR, Rocco MV, Freedman BI; Systolic Blood Pressure Intervention Trial (SPRINT). Kidney International 87: 169-175, 2015; and
APOL1 risk variants, race, and progression of chronic kidney disease. Parsa A, Kao WH, Xie D, Astor BC, Li M, Hsu CY, Feldman HI, Parekh RS, Kusek JW, Greene TH, Fink JC, Anderson AH, Choi MJ, Wright JT Jr, Lash JP, Freedman BI, Ojo A, Winkler CA, Raj DS, Kopp JB, He J, Jensvold NG, Tao K, Lipkowitz MS, Appel LJ; AASK Study Investigators; CRIC Study Investigators. N Engl J Med 369: 2183-2196, 2013.
Genetic Factors in Kidney and Cardiovascular Disease: African Americans with two copies of certain variants of the APOL1 gene are at increased risk of developing kidney disease that is not related to diabetes. These individuals are also twice as likely to progress to kidney failure as those who do not have the high-risk variants. Moreover, African Americans with the high-risk variants tend to lose kidney function at twice the rate of those without them. However, these APOL1 variants are not associated with an increased risk of cardiovascular disease in African Americans with high blood pressure. As a key priority in treating high blood pressure is to reduce the risk of both kidney and cardiovascular diseases in all patients, ongoing research is seeking to identify the role played by APOL1 in these two processes. Fiscal Year 2015: No Current Data Available Fiscal Year 2016: No Current Data Available

 



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