The aim of this proposal is to enable Dr. Ojo to devote 50% effort to conduct clinical research and to mentor patient-oriented research trainees. The research projects that will be principally utilized for the proposed mentoring plan are: (1) The Chronic Renal Insufficiency Cohort Study (CRIC); (2) The Folic Acid for Vascular Outcome Reduction in Transplantation Study (FAVORIT); and (3) The Scientific Registry for Transplant Recipients (SRTR). CRIC is an NIH-sponsored, multicenter, prospective cohort study designed to determine the risk factors for accelerated decline in renal function and to evaluate the incidence and risk factors for cardiovascular disease (CVD) in patients with chronic renal insufficiency (CRI). The CRIC will provide the mentored trainees with hands-on application of a nonexperimental study design. The FAVORIT is an NIH-sponsored, multicenter, randomized, double-blind controlled clinical trial designed to determine whether total homocysteine (tHcy)-lowering treatment with a standard multivitamin augmented by a high dose combination of folic acid, vitamin B 12, and vitamin B6 versus treatment with a standard multivitamin devoid of these three B-vitamins, reduces the pooled rate of recurrent and de novo CVD outcomes in stable renal transplant recipients. The FAVORIT will be used as a template to instruct the trainees in the design, conduct and analysis of randomized clinical trials. The SRTR is a longitudinal database designed to conduct scientific investigations of patient-centered outcomes relevant to solid organ retrieval, allocation, and transplantation in the U.S. The SRTR will serve the trainee as a practicum for hypothesis-driven clinical epidemiologic outcome studies. Mentoring Plan: This award will entail the development and implementation of an integrated mentoring program starting from the first year of fellowship and consisting of three key components: (1) the practical experience of an observational study of 500 patients (CRIC), a randomized therapeutic clinical trial of 200 patients (FAVORIT) and outcomes analyses with a database of 300,000 organ recipients (SRTR); (2) rigorous didactic instructions in patient-oriented research methodologies through a Master degree in Clinical Research or Epidemiology program or flexibly designed set of course work; and (3) continuous training on rights, ethics and responsibilities in research with human subjects through the University of Michigan Research Responsibility Program.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Midcareer Investigator Award in Patient-Oriented Research (K24)
Project #
5K24DK062234-05
Application #
7120612
Study Section
Diabetes, Endocrinology and Metabolic Diseases B Subcommittee (DDK)
Program Officer
Rankin, Tracy L
Project Start
2002-09-24
Project End
2008-08-31
Budget Start
2006-09-01
Budget End
2008-08-31
Support Year
5
Fiscal Year
2006
Total Cost
$143,226
Indirect Cost
Name
University of Michigan Ann Arbor
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
073133571
City
Ann Arbor
State
MI
Country
United States
Zip Code
48109
Adeoye, Abiodun M; Tayo, Bamidele O; Owolabi, Mayowa O et al. (2018) Ambulatory blood pressure threshold for black Africans: more questions than answers. J Clin Hypertens (Greenwich) 20:847-849
Warren, Patricia H; Gifford, Kimberly A; Hong, Barry A et al. (2014) Development of the National Living Donor Assistance Center: reducing financial disincentives to living organ donation. Prog Transplant 24:76-81
Sun, Qiquan; Ojo, Akinlolu O; Li, Xian C (2014) Immunological aspect on late allograft dysfunction. J Immunol Res 2014:625031
Sharif, A; Hecking, M; de Vries, A P J et al. (2014) Proceedings from an international consensus meeting on posttransplantation diabetes mellitus: recommendations and future directions. Am J Transplant 14:1992-2000
Hecking, Manfred; Werzowa, Johannes; Haidinger, Michael et al. (2013) Novel views on new-onset diabetes after transplantation: development, prevention and treatment. Nephrol Dial Transplant 28:550-66
Dobre, Mirela; Yang, Wei; Chen, Jing et al. (2013) Association of serum bicarbonate with risk of renal and cardiovascular outcomes in CKD: a report from the Chronic Renal Insufficiency Cohort (CRIC) study. Am J Kidney Dis 62:670-8
Ojo, Akinlolu O; Morales, José María; González-Molina, Miguel et al. (2013) Comparison of the long-term outcomes of kidney transplantation: USA versus Spain. Nephrol Dial Transplant 28:213-20
Kulshrestha, Satyarth; Ojo, Akinlolu O; Luan, Fu L (2013) Metabolic syndrome, vitamin D deficiency and hypoadiponectinemia among nondiabetic patients early after kidney transplantation. Am J Nephrol 37:399-404
Heung, Michael; Wolfgram, Dawn F; Kommareddi, Mallika et al. (2012) Fluid overload at initiation of renal replacement therapy is associated with lack of renal recovery in patients with acute kidney injury. Nephrol Dial Transplant 27:956-61
Luan, Fu L; Kommareddi, Mallika; Cibrik, Diane M et al. (2012) The time interval between kidney and pancreas transplantation and the clinical outcomes of pancreas after kidney transplantation. Clin Transplant 26:403-10

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