REQUEST FOR ADDITIONAL CLINICAL SITES TO PARTICIPATE IN A TRIAL OF TREATMENT OF TYPE 2 DIABETES IN CHILDREN AND ADOLESECNTS Release date: May 2, 2002 Notice: NOT-DK-02-005 National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (http://www.niddk.nih.gov) The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) seeks additional clinical sites to participate in a multi-arm, multi-center trial to study the treatment of type 2 diabetes in the pediatric population. Type 2 diabetes has been traditionally viewed as a disease of adults; however, recent epidemiologic data reveal an increasing number of cases of type 2 diabetes in the pediatric population, especially among adolescents and in certain minority populations. The increase of type 2 diabetes in children and adolescents is presumed to be a consequence of widespread obesity and decreased physical activity. When children develop diabetes, efficacious therapy is needed to maintain euglycemia in order to prevent the development of complications. The drugs currently approved for use in adults with type 2 diabetes have generally not been systematically studied in children. Thus, treatment options for those children diagnosed with type 2 diabetes are restricted by the lack of data on the use of such pharmacologic agents. Optimal treatment of type 2 diabetes in children, as well as in adults, should go beyond merely achieving euglycemia. Ideally, therapy would reverse insulin resistance and preserve or improve beta cell function. However, little is known about which particular classes of agents used to treat type 2 diabetes might be advantageous in helping to maintain insulin secretion and preventing the inexorable slide to insulin treatment which ultimately characterizes type 2 diabetes. The goal of this clinical trial will be to help establish appropriate and effective treatment regimens for children with type 2 diabetes. Planning for this trial has begun under a cooperative agreement funded under RFAs DK01-010 (http://grants.nih.gov/grants/guide/rfa-files/RFA-DK-01-010.html) and DK01-011 (http://grants.nih.gov/grants/guide/rfa- files/RFA-DK-01-011.html) which invited applications for clinical sites and a Coordinating Center.. The cooperative agreement is funded for 7 years, anticipating three phases: 1) planning, 2) recruitment and study, and 3) analysis. Currently, a Steering Committee, composed of the Principal Investigators from the clinical sites, the Principal Investigator of the Coordinating Center, an NIDDK representative, and several outside experts, is beginning protocol development for this trial. However, additional, clinical sites are needed to assure adequate power, as well as geographic and racial/ethnic diversity. It is the intent of the NIDDK to add additional clinical sites in a timely manner, so that these new sites can participate in the planning process for the trial. Awards to additional clinical sites will be made through subcontracts from the Coordinating Center. Funding is available in the first year for travel of the principal investigator to planning meetings, as well as for effort commensurate with the level of participation in protocol development. Once the trial begins, the subcontracts will provide funds to each center to support personnel, supplies, equipment, communication, travel and patient care costs associated with the study. The award will depend on the requirements of the protocol ultimately designed by the Steering Committee. It is anticipated that Principal Investigators from the new sites will serve on the Steering Committee. Requests to participate may be submitted by institutions in the United States and Canada. This geographic constraint is necessary because of the need for close communication and meetings among members of the Steering Committee. Requests should be submitted on a PHS 398 (http://grants.nih.gov/grants/forms.htm). Each request should have a face page, abstract, biographical sketch, description of resources, and a research plan. The biosketch should include a description of all active research support and a description of recently completed projects. A budget is not needed. The research plan should not exceed 5 pages and should include: 1) a brief proposal for the design of the trial, with a discussion of the rationale for selecting this design, as well as the choice of outcome measures; 2) a detailed description of the proposed trial population at the site (including the number of children with newly diagnosed type 2 diabetes seen annually, the number of children with type 2 diabetes currently followed, the number of children diagnosed within the past year who could be expected to be recruited into the trial, the anticipated drop out rate, and the gender, racial and ethnic composition of the population); and 3) a description of the Principal Investigator's experience in multi-center or large clinical trials. The investigator should discuss all trials in which he/she played a significant role, and include an explanation of that role, as well as a description of the numbers (or percent) of eligible patients successfully recruited to these trials. Human subject issues, as required in the instructions for the PHS 398, must be addressed. Requestors must also document their willingness to participate on the Steering Committee and appropriate subcommittees, work cooperatively with the other members of the Steering Committee, and follow the common protocols established cooperatively by the Steering Committee. Details regarding the "Terms and Conditions" of this cooperative agreement can be found in the original RFA. Requests (2 copies) should be submitted no later than June 7, 2002 to: Barbara Linder, M.D., Ph.D. Division of Diabetes, Endocrinology and Metabolic Diseases National Institute of Diabetes, Digestive and Kidney Diseases 6707 Democracy Blvd., Rm. 699, MSC 5460 Bethesda, MD 20892-5460 (for courier service, use zip code 20817) Telephone: (301) 594-0021 FAX: (301) 480-3503 E-mail: linderb@extra.niddk.nih.gov All inquiries should also be directed to Dr. Linder. Requests will be reviewed by a panel convened by the Coordinating Center (the George Washington University), and evaluated according to the following criteria: o completeness of the request o ability of the potential site to recruit and retain subjects for the trial o need for geographic and racial/ethnic diversity within the study population o ability of the investigator to make an intellectual contribution to the collaborative effort It is anticipated that six to ten additional sites will be supported. Investigators submitting requests will be eligible to receive travel support to participate in a meeting in early July to discuss protocol design. Subcontracts will be awarded once it has been determined exactly how many patients will need to be recruited.
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