The National Institute of Diabetes & Digestive & Kidney Diseases

May 30-31, 2001 - Meeting Minutes

Department of Health and Human Services
Public Health Service
National Diabetes and Digestive and Kidney Diseases
Advisory Council
May 30-31, 2001

I. CALL TO ORDER

NIDDK Director Dr. Allen Spiegel called to order the 156th National Diabetes and Digestive and Kidney Diseases Advisory Council meeting on May 30, 2001, at 8:35 a.m. in Conference Room E1, Building 45.

A. ATTENDANCE

COUNCIL MEMBERS PRESENT 
Mr. David Baldridge
Dr. Edward J. Benz, Jr.
Dr. D. Montgomery Bissell,
Dr. Jose Caro
Dr. Jeffrey I. Gordon
Hon. Levan Gordon
Dr. Edward W. Holmes
Ms. Genevieve R. Jackson
Dr. C Ronald Kahn
Dr. Carolyn Kelly
Dr. James W. Kikendall (Ex officio)
Dr. John McConnell
Dr. Kristen W. McNutt
Dr. Daniel K. Podolsky
Dr. Daniel Porte Jr. (Ex Officio)
Dr. Sandra Puczynski
Dr. Vicki Ratner
Dr. Robert W. Schrier
Dr. Joseph T. Spence (Ex Officio)
Dr. Ming-Jer Tsai
Dr. Rena R. Wing

B. NIDDK STAFF AND GUESTS

In addition to Council members, others in attendance included NIDDK staff members, representatives of the NIH Office of the Director (OD), Center for Scientific Review (CSR) Scientific Review Administrators, and other NIH staff members. Guests were present during the open sessions of the meeting. Attendees included the following:

Beena Akolkar, NIDDK; Syed Amir, CSR; David Badman, NIDDK; Michele Barnard, NIDDK; Carolyn Benson, NIDDK; Sharon Bourque, NIDDK; Josephine Briggs, NIDDK; Ben Burton, NIDDK; Francisco Calvo, NIDDK; Dolph Chianchiano, National Kidney Foundation; Cheryl Chick, NIDDK; Catherine Cowie, NIDDK; Leslie Curtis, NIDDK; Charlenia Daniels, NIDDK; Florence Danshes, NIDDK; Jane DeMouy, NIDDK; Susan Dobert, WCF; Jackie Dobson, NIDDK; Linda Edgeman, NIDDK; Gayla Elder-Leak, NIDDK; William Elzinger, NIDDK; James Everhart, NIDDK; Richard Farishian, NIDDK; Teresa Farris, NIDDK; Thorsten Fjellstedt, NIEHS; Judith Fradkin, NIDDK; Sanford Garfield, NIDDK; Deb Hamernik, CSR; Robert Hammond, NIDDK; Joan Harmon, NIDDK; Mary Harris, NIDDK; Maureen Harris, NIDDK; Barbara Harrison, NIDDK; Trude Hillard, NIDDK; Jay Hoofnagle, NIDDK; Karen Howard, NIDDK; Van S. Hubbard, NIDDK; Donna Huggins, NIDDK; Stephen James, NIDDK; Ephraim Johnson, NIDDK; Kieran Kelley; NIDDK; Charlette Kenley, NIDDK;

Mary Beth Kester, NIDDK; Soonja K. Kim, CSR; John Kusek, NIDDK; Kim M. Law, NIDDK; Todd Le, NIDDK; Gavin Lindberg, CCFA; Diana Ly, NIDDK; Billie Mackey, NIDDK; Denise Manoulian, NIDDK; Donita Marconi, NIDDK; Ronald Margolis, NIDDK; Michael Martin, CSR; Dan Matsumoto, NIDDK; Michael K. May, NIDDK; Dave Miller, NIDDK; Barbara Minor, NIDDK; Marjani Mitchell, NIDDK; Neal Musto, NIDDK; Beth Paterson, NIDDK; Judith Podskalny, NIDDK; Sharon Pope, NIDDK; Alice Robinson, NIDDK; Patricia Robuck, NIDDK; Griffin Rodgers, NIDDK; Mary Rosenburg, NIDDK; Lakshmanan Sankaran, NIDDK; Paula Skedsvold, OD; Jose Serrano, NIDDK; M. James Sherbenske, NIDDK; Michelle Shorter, NIDDK; Elizabeth Singer, NIDDK; Philip F. Smith, NIDDK; Gloria Snowden, NIDDK; Robert Star, NIDDK; George Tucker, NIDDK; Ranetta Turner, NIDDK; Dorothy West, NIDDK; Wanda White, NIDDK; Rita Yeager, NIDDK; Charles Zellers, NIDDK.

C. CONFLICT OF INTEREST STATEMENT

Dr. Robert Hammond called to the attention of the Council the Confidentiality and Conflict of Interest Statements. After discussing the scope of confidentiality and conflict of interest, he requested that Council members comply with the requirements. He reminded Council members to avoid a conflict of interest by leaving the room when the Council discussed individual applications in which an actual or perceived conflict of interest might occur. Members were asked to sign a statement to this effect. Dr. Hammond noted that recusal is not required for "en bloc" actions.

Dr. Allen Spiegel announced that the Council meeting would be open to the public in accordance with the provisions of Public Law 92-463 on Wednesday, May 30, 2001, from 8:30 a.m. to 12:30 p.m.; and closed from 1:30 p.m. until 5:30 p.m. On Thursday, May 31, 2001, the meeting would be closed from 8:00 a.m. until 10:15 a.m. for review, discussion, and evaluation of grant applications; and open from 10:15 a.m. until the close of the meeting at approximately 12 noon.

II. CONSIDERATION OF THE SUMMARY MINUTES OF THE PREVIOUS MEETING

The Council members present accepted the summary minutes of the February 2000 NDDK Advisory Council meeting unanimously.

III. FUTURE MEETING DATES

Dr. Spiegel asked for consideration of meeting dates for future NDDK Advisory Council meetings, and the following meeting dates were proposed and accepted:

September 20-21, 2001
February 13-14, 2002
May 30-31, 2002
September 18-19, 2002
February 19-20, 2003
June 11-12, 2003
September 24-25, 2003

IV. DIRECTOR'S REPORT

Dr. Spiegel began his report by introducing a new member of Council: Colonel James W. Kirkendall, who is an ex officio member representing the Department of Defense. Dr. Kirkendall, a physician, is Director of Clinical Services for Gastroenterology at Walter Reed Army Medical Center. He will be a member of the Digestive Diseases and Nutrition sub-Council.

Dr. Spiegel announced that Mr. David Mineo is the new NIDDK Grants Management Officer. He also announced that Dr. Monica Liebert, in the Division of Kidney, Urologic, and Hematologic Diseases, will be leaving the NIDDK to join the American Urological Association; and that Dr. Joan Harmon, in the Division of Diabetes, Endocrinology, and Metabolic Diseases will be leaving to join the NIH’s National Institute of Biomedical Imaging and Bioengineering.

Dr. Spiegel, along with Council member Dr. John McConnell, noted the sudden passing, at age 50, of NIDDK grantee Dr. Gary Miller, a world expert in prostate pathology at the University of Colorado.

Dr. Spiegel announced the recent election to the National Academy of Sciences of NIDDK grantees Dr. Jeffrey Friedman at Rockefeller University, Dr. Richard Lifton at Yale University, and Council member Dr. Jeffrey Gordon at Washington University.

Dr. Spiegel then highlighted two recent, independent scientific advances related to Crohn’s disease, reported in the May 31, 2001, issue of Nature. The studies show that the previous site of linkage for Crohn’s disease, an inflammatory bowel disease (IBD), on chromosome 16, harbors a gene called NOD2. In its heterozygous variant form, this gene increases susceptibility to Crohn’s disease, but in its homozygous form it very dramatically increases susceptibility. The NOD2 gene turns out to be responsible, in part, for the innate immune response to bacteria in the gut, and studies now will be conducted to determine how the gene causes susceptibility. The NIDDK, the National Cancer Institute, and the Crohn’s and Colitis Foundation of America (CCFA) all were involved in supporting aspects of this research. This is an example of a very targeted, focused, and interdisciplinary approach to biological problems, where NCI-supported investigators at the University of Michigan studying a gene family found–using data from the Human Genome Project-that NOD2 was at the IBD locus on chromosome 16, and then collaborated with NIDDK-supported researchers at the University of Chicago who were studying families of Crohn’s disease patients to examine the sequence of the gene. The CCFA supported the very early high-risk work on the initial aspects of this study, which was then leveraged by the NIDDK.

Dr. Spiegel then noted that sub-Councils would be discussing the Institute’s draft program initiative concepts for fiscal year (FY) 2002. He indicated that the concepts would be posted on the NIDDK homepage, primarily to provide a "heads up" to investigators. He also stressed that the initiative concepts involve certain assumptions about the FY 2002 budget, and that implementation of initiatives will be related to the Institute’s actual appropriation for next year.

Dr. Spiegel discussed his involvement in a variety of meetings and briefings with the Institute’s professional and voluntary constituencies, patient groups, DHHS Secretary Tommy Thompson, and the U.S. Congress. He also participated in the March 16 ceremony that unveiled the diabetes awareness stamp by the U.S. Postal Service. The event was hosted at the Joslin Diabetes Clinic by Council member Dr. Ronald Kahn. Dr. Spiegel turned to Dr. Kahn, who remarked that the stamp is significant for two reasons. First, gaining recognition with a stamp is a very competitive process-the Postal Service recognizes with a stamp only one "social issue" each year, and this year diabetes awareness was chosen. The second point is that the stamp creates tremendous public awareness through the 100 million stamps that are issued.

Dr. Spiegel also commented on his participation in two hearings of the House Labor-HHS-Education subcommittee of the Committee on Appropriations. The first hearing, held on March 28, was a “theme” hearing on chronic diseases. The second was the overall FY 2002 NIH budget hearing on May 16. Dr. Spiegel responded to a number of questions at both hearings. In addition, the Senate hearing on NIH appropriations took place on May 23.

Dr. Spiegel then commented briefly on FY 2002 and FY 2003 planning in relation to budget. A major emerging issue is the interplay of obesity and diabetes, specifically in the prevention area. Diabetes prevention also is a priority area of HHS Secretary Thompson. A Council member suggested that a study should be conducted on the health outcomes of the diabetes-obesity epidemic as a way of predicting the long-term health and economic impact of diabetes. Dr. Spiegel and Dr. Fradkin agreed that new, more recent data are needed, and that the NHANES (National Health and Nutrition Examination Survey) project conducted by the Centers for Disease Control and Prevention (CDC) is moving to a rolling system that will collect information continuously. In addition, the NIDDK and CDC are collaborating on a project that, for the first time, will define the incidence of type 1 and type 2 diabetes in children.

V. BUDGET REVIEW

Dr. Spiegel asked Dr. Griffin Rodgers, NIDDK Deputy Director, to discuss the FY 2002 President’s Budget. For NIH, the President has requested a 13.5 percent increase over FY 2001. Dr. Rodgers reviewed some details of the NIDDK budget while referring to a mechanism table that was distributed. Research Project Grants represent 73 percent of the Institute’s budget, the largest component by mechanism. He compared and contrasted the distribution of funds across the various mechanisms in the NIDDK budget with the "NIH Average."

A Council member asked about how NIH-supported investigators might be assisted in gaining access to commercial proteomic and genomic databases, and how buying power might be leveraged to gain access. Dr. Spiegel pointed out that NCI is leading negotiations with Celera for access for NIH intramural investigators, and that coalitions of extramural investigators may be formed for a similar purpose. He indicated, however, that the NIH probably should not be the vehicle for organizing such groups. On the other hand, the Institute is very much interested in developing trans-NIDDK initiatives-such as the gene profiling initiative-to enhance economies of scale, standardization, and quality control. Dr. Spiegel indicated he would convey to IC directors the Council’s concern that NIH should give greater consideration to the costs of doing research in academic medical centers.

There was some discussion on the possibility of increasing or decreasing use of certain budget mechanisms to accommodate desirable programmatic adjustments, and on budget approaches to NIH "post-doubling." With regard to the latter, a Council member noted that the NIH should not necessarily settle for a "soft landing," and that efforts should be made to maintain major annual increases in the NIH budget after FY 2003.

Dr. Rodgers then discussed medical student loan repayment. Three specific pieces of legislation have authorized loan repayment: The Minority Health and Health Disparities Research and Education Act of 2000, the Children’s Health Act of 2000, and the Public Health Improvement Act of 2000. The President’s Budget for FY 2002 requests $25 million for this purpose; approximately 250 individuals could be supported. Repayment would be $35,000 per year per individual, for a minimum of two years. The NIDDK was assigned to support 13 awards, and made the decision to increase that number to 20.

VI. PRESENTATION: OFFICE OF BEHAVIORAL AND SOCIAL SCIENCES RESEARCH AT NIH - FUTURE RESEARCH DIRECTIONS

Dr. Spiegel introduced Dr. Raynard Kington, who is Associate Director of the NIH Office of Behavioral and Social Sciences Research (OBSSR). Dr. Kington presented an overview of his Office, which aims to enhance behavioral and social sciences research and research training throughout NIH, to expand a biobehavioral interdisciplinary perspective in the NIH institutes, and to improve communication both among health scientists and with the public about important advances in behavioral and social sciences. Dr. Kington referred to a National Research Council plan for behavioral and social science research that was released in January 2001.* He discussed the ten priority areas of research identified in the report: Pre-disease pathways, positive health, gene expression, personal ties, healthy communities, inequality, population health, interventions, methodology, and infrastructure. Dr. Kington stressed the need for OBSSR partnerships across the NIH institutes and centers, specifically in conducting workshops and in developing trans-NIH initiatives. He noted particular recent efforts with the NIDDK, which included a conference on Depression and Mental Disorder in Persons with Diabetes, Renal Disease, and Obesity/Eating Disorders. Type 2 diabetes and obesity are major areas of potential collaboration.

* New Horizons in Health: An Integrative Approach. Committee on Future Directions for Behavioral and Social Sciences Research at the National Institutes of Health, Commission on Behavioral and Social Sciences and Education, National Research Council

VII. SCIENTIFIC PRESENTATION: RESISTIN - A POTENTIAL LINK BETWEEN OBESITY AND DIABETES

Dr. Spiegel introduced Dr. Mitchell Lazar, who is Chief of the Division of Endocrinology, Diabetes, and Metabolism; Professor of Medicine and Genetics; and Director of the Diabetes Center at the University of Pennsylvania. Dr. Lazar presented results of his research on a new family of peptides called the "resistins," which may provide a link between obesity and the development of type 2 diabetes.

In the course of studying how the nuclear hormone receptor PPAR-gamma-which is expressed predominantly by adipose tissue-regulates gene expression in mice, Dr. Lazar discovered a protein that is increased in its expression during adipocyte differentiation, but that is down-regulated by the anti-diabetic agent rosiglitizone, a thiozolidinedione (TZD). TZDs, in nanomolar amounts, are ligands for PPAR-gamma, and very effectively treat the insulin resistance found in type 2 diabetes. Dr. Lazar named the protein resistin. He showed that resistin is very restricted in its expression to white adipose tissue, that obesity leads to increased resistin levels, that anti-resistin antibodies and TZDs each reduce resistin levels, and that resistin’s 94 amino acid sequence suggests it is a signaling molecule. Dr. Lazar suggests that resistin causes insulin resistance by blocking the action of insulin, and currently he is attempting to identify the resistin receptor. His lab also is attempting to produce knockout mice to understand the normal function of resistin.

With regard to human resistin, Dr. Lazar’s group has identified two resistin genes, one they are calling resistin, and other they are calling RELM-beta, which has an intestinal pattern of expression. The human resistin protein is about 60 percent homologous to mouse resistin. Dr. Lazar believes that there is a third human resistin gene, and his group is searching for it.

Following Dr. Lazar’s presentation, a Council member noted that, in its early phase, Dr. Lazar’s project was considered "high-risk" research, and yet it has now yielded important and provocative information that opens up the field. Dr. Spiegel asked whether RELM-beta, the intestinal resistin, is regulated by TZDs. Dr. Lazar indicated that preliminary data show that it is, and that it is possible that this peptide is part of the loop between the gut and brain that regulates food intake. Dr. Lazar also mentioned that another group, at the University of California at Berkeley, has independently discovered an adipocyte-derived secretory factor that appears to be very similar to resistin.

VIII. ELECTRONIC COUNCIL BOOK PRESENTATION

Dr. Hammond introduced Dr. Thorsten Fjellstedt, Deputy Director of the Division of Extramural Research and Training at the National Institute of Environmental Health Sciences, who gave a brief presentation on recent enhancements to the Electronic Council Book. He gave a preview of the Book that will be used for the September/October NIH Council meetings, and asked the NIDDK Council for input. Some of the new features are expanded search parameters, the ability to access and print multiple Summary Statements, the capability to send e-mail to appropriate program staff, the ability to download Summary Statements as a PDF or zip file, and a 'resume hit list" feature. One Council member asked whether, for amended applications, the previous Summary Statement would be available. Dr. Fjellstedt answered that this information certainly would be useful to the Council, and that this suggestion would be given serious consideration. Another Council member asked whether a hyperlink could be included in the Summary Statement for an investigator’s "other funding." Dr. Fjellstdt commented that, while technically possible, Institute and Center Directors would have to decide whether this information would be provided.

Dr. Spiegel adjourned the meeting at approximately 12:30 p.m. At approximately 1:30 p.m., separate meetings were convened of the Diabetes, Endocrinology, and Metabolic Diseases sub-Council; the Digestive Diseases and Nutrition sub-Council; and the Kidney, Urologic, and Hematologic Diseases sub-Council.

On May 31, at approximately 9:00 a.m., Dr. Spiegel reconvened the meeting of the full NDDK Advisory Council.

IX. CONSIDERATION OF TRANS-NIH NIDDK INITIATIVES AND

X. UPDATE FROM TRANS-NIDDK PLANNING GROUPS

By way of introduction, Dr. Hammond noted that these topics were being merged because some trans-NIDDK initiative concepts emanated from the trans-NIDDK planning groups. (Division-specific initiatives were discussed previously in the three sub-Council meetings.) Five trans-NIDDK initiative concepts were discussed. Capsule descriptions of the concepts were distributed. Dr. Serrano presented the first, entitled "Identification of Genetic Modifiers of Monogenic Diseases." After brief discussion, the Council approved this concept.

Dr. Agodoa presented the second trans-NIDDK initiative concept, entitled "Training of Minority Medical Students through NIDDK Centers." After discussion, including suggestions for modifications, Council approved the concept.

The third and fourth trans-NIDDK initiative concepts emanated from the trans-NIDDK planning groups on "Genetics, Genomics, and Bioinformatics" and "Stem Cells and Developmental Biology." Dr. Smith presented them in the context of updating the activities of these planning groups. He noted that both groups agreed that a paradigm is needed that is inclusive and that funds large projects in the genomics area (large genome anatomy programs), and also develops a mechanism to allow participation of the larger NIDDK research community.

Dr. Holmes, the Discussion Leader for the Genetics, Genomics, and Bioinformatics planning group, provided the rationale for the first trans-NIDDK initiative concept, entitled "Working Group Recommendation To Link Genome Anatomy Programs (GAPs) with Individual Investigator-Initiated Projects." One premise is that there is a need for more investigators skilled in bioinformatics as it relates to biology and medicine. One recommendation of his planning group, therefore, was that a strategy is needed to attract leading researchers in the field of bioinformatics, to develop a strategy to tap into expertise in bioinformatics that exists in other places, and to train more individuals in this area. A second recommendation was to identify programs to benefit a wide array of NIDDK investigators-the formation of genome anatomy programs-and to use these programs to disseminate reagents, tools, protocols, and expertise to individual investigators across the NIDDK. Thus, the joint recommendation was to develop a model of genome anatomy projects that would address the needs of researchers, and would bring together state-of-the-art bioinformatics expertise to NIDDK researchers. Programs would pilot methods that link together individual researchers.

Dr. Gordon, the Discussion Leader for the Stem Cells and Developmental Biology planning group, discussed the goal of the second trans-NIDDK initiative concept, entitled "Working Group Recommendations for Creation of Programs in Progenitor Cell Genomics." It is to characterize the molecular features of stem cells during development, that is, to promote innovative methods for identifying stem cells in model organisms and in human tissues through clonogenic assays or other means. There are two elements to the proposal. The first is the sponsorship of two major genome anatomy programs, which would attempt to describe transcripts, as well as the products of the transcripts and potential protein-protein interaction networks. The second element would provide supplements to ongoing NIDDK-supported grants that already focus on progenitor subpopulations in developing adult tissues relevant to the NIDDK mission.

After discussion, the Council approved these two concepts.

Before introducing Dr. Garfield to present the fifth trans-NIDDK initiative concept, entitled "Central Repository and Coordinating Center for NIDDK Biologic Specimens," Dr. Rodgers noted that this initiative emanated from the third trans-NIDDK planning group, on Disease Prevention and Management. In addition, this group has drafted a document to provide the NIDDK with input on setting up large, multi-center clinical trials. Dr. Rodgers indicated the document may be formally presented to Council in September. Dr. Garfield then outlined the initiative, the purpose of which is to provide the scientific community with a storage facility, data management, coordinated oversight of collected samples, and access to samples derived from NIDDK-sponsored clinical trials. Following the presentation, Dr. Spiegel briefly discussed related issues, including informed consent and sample ownership. One Council member suggested that linking phenotypes to samples would be a critical component of such a repository; Dr. Spiegel agreed that this must be a key consideration. The Council approved the concept.

XI. REPORTS FROM DIVISION DIRECTORS

A. Division of Intramural Research

Dr. Spiegel introduced Dr. Marvin Gershengorn, the Institute’s Scientific Director designee, who presented the Division report. Dr. Gershengorn outlined two major new initiatives that the Institute will be pursuing. The first involves studies on the endocrine pancreas, and beta cells in particular, in the Diabetes Branch. Investigation of adult stem cells within the endocrine pancreas, including understanding the stages of progenitor cell progression, will be undertaken. Regulation of beta cell gene expression will be explored, with particular emphasis on understanding which transcriptional regulators are important in the development of stem cells through the progenitor cell stage to the mature hormone-producing cells of the endocrine pancreas. Other scientists will be studying intracellular beta cell signaling, as well as intercellular communication. That is, why is the Islet of Langerhans configured the way it is, and how do the hormone-producing cells within the islet communicate with one another? Recruitment is underway to provide staffing for this initiative.

The second initiative involves the creation of a new laboratory called the Laboratory of Biological Modeling, which relates not only to bioinformatics but also to the application of all mathematical and computational approaches to biology. The emphasis again will be on the endocrine pancreas.

The bioinformatics component will aim to develop methods and tools to understand the expression patterns of genes in the endocrine pancreas during development. A molecular biophysics component will use a theoretical or computational approach to try to understand the structure and function of macromolecules, and how macromolecular interactions lead to cell regulation. A third component will be the development of mathematical models that would promote understanding of how cells are regulated. It is Dr. Gershengorn’s hope that there will be a synergy between the beta cell biology group and the modeling group.

Dr. Gershengorn also discussed briefly an expanded effort in the area of peripheral insulin action, the development of a core microarray facility, the establishment of a new Office of Postdoctoral Fellowship Training and an Office for Clinical Research Support Services, and the recruitment of new leadership for the Institute’s GI consultation service for the NIH.

Dr. Spiegel emphasized that, with these two major initiatives, the NIDDK wishes to be a leader in bringing every aspect of genomics and proteomics to bear to understand all aspects of the beta cell.

B. Division of Digestive Diseases and Nutrition

Dr. Jay Hoofnagle presented the report for the Division. He noted that the DDN sub-Council approved four initiative concepts. The first is to study Barrett’s esophagus, GERD, and esophageal carcinoma. The second is to encourage applications in digestive diseases and nutrition using the exploratory/developmental research grant mechanism (R21). The third is an initiative on the genetics of inflammatory bowel disease. The fourth is an initiative on liver and pancreatic disease in HIV patients. Dr. Hoofnagle noted that liver disease is the single greatest cause of death in patients with HIV today. Dr. Hoofnagle also announced two upcoming conferences, one on endoscopic retrograde cholangiopancreatography, and a Consensus Development Conference update on the management of hepatitis C.

C. Division of Diabetes, Endocrinology, and Metabolic Diseases

Dr. Fradkin presented the report for the Division. She updated the group on the Institute’s initiatives in type 1 diabetes. She first mentioned three upcoming conferences. The first is entitled: Pancreatic Development, Proliferation and Stem Cells. The second will focus on beta cell signaling. The third will examine how networks of people at risk for type 1 diabetes can be used to determine environmental triggers for the disease. It is anticipated that a trans-NIH initiative will emanate from this conference.

Dr. Fradkin turned to Council member Dr. Ronald Kahn, who paid special tribute to NIDDK diabetes program director Dr. Joan Harmon, who is leaving the Institute to join the NIH’s new National Institute of Biomedical Imaging and Bioengineering.

D. Division of Kidney, Urologic, and Hematologic Diseases

Dr. Briggs presented the report for the Division. She announced two upcoming meetings. The first is a meeting on genomics and proteomics in kidney and urologic diseases, and the second is a planning meeting of the National Kidney Disease Education Program. Dr. Briggs also noted that a review of the Institute’s urology program will take place this summer with a meeting of the Bladder Research Progress Review Group.

Two clinical trials consortia also are being planned. One deals with vascular access-an important problem for dialysis patients-while the other is a trial that will evaluate surgical methods for treatment of urinary incontinence.

Two initiatives are under review within the Division: A long-term chronic renal insufficiency cohort study-a "renal Framingham" study-and a proposal to compare surgical approaches using new technologies with standard transurethral prostatectomy.

The NIDDK also is examining the issue of more frequent daily or nocturnal kidney dialysis. The Institute is collaborating with the Centers for Medicare and Medicaid Services (formerly the Health Care Financing Administration) to develop a procedure for co-funding a study in this area.

Dr. Briggs then discussed efforts to develop an initiative for pilot and feasibility studies for interventions that would prevent or slow progression of diabetic nephropathy, with the hope that these studies would lead to large-scale intervention studies.

Lastly, Dr. Briggs noted that the Division is working with existing cohorts of diabetic patients, particularly from the EDIC study, to evaluate the possibility of supplemental studies to delineate the extent and risks for urologic complications, bladder voiding disorders, and sexual dysfunction. The Division is also working with the Division of Diabetes, Endocrinology, and Metabolic Diseases on the initiative on surrogate markers for disease susceptibility.

E. Division of Extramural Activities

Dr. Hammond presented the report for the Division. Giving Council advance notice of a major activity for its September meeting, he referred to a listing of requests for applications that was distributed to the membership. The initial review of the applications received from these RFAs will be performed in June and July. The summary statements will be included in the Electronic Council Book in August and the early part of September. The applications then will come to the Council for second-level review in September. The NIDDK is the primary sponsor of 12 RFAs, and is a secondary sponsor on an additional 10.

XII. CONSIDERATION OF REVIEW OF GRANT APPLICATIONS

A total of 1,037 grant applications, requesting support of $205,416,532 were reviewed for consideration at the May 30-31, 2001 meeting. Funding for those 1,037 applications was recommended at a level of $203,373,433.

Dr. Spiegel thanked the Council members for their attendance and advice. There being no other business, Dr. Spiegel adjourned the 156th meeting of the NDDK Advisory Council on May 31, 2001, at 12 noon.

I hereby certify that, to the best of my knowledge, the foregoing summary minutes and attachments are accurate and complete.

Allen Spiegel, M.D. Director, National Institute of Diabetes and Digestive and Kidney Diseases And Chairman, National Diabetes and Digestive and Kidney Diseases Advisory Council