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| Sponsor: | Michael Mauer, MD |
|---|---|
| Collaborators: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) National Institutes of Health (NIH) |
| Information provided by: | University of Minnesota - Clinical and Translational Science Institute |
| ClinicalTrials.gov Identifier: | NCT00156364 |
Purpose
A. To study the effects of pancreas transplantation (PT) on the structural abnormalities of diabetic nephropathy (DN) in patients with type 1 (insulin-dependent) diabetes mellitus (type 1 D). These studies will address the influence of long-term normoglycemia on two stages of diabetic renal disease.
Hypothesis: The benefits of PT on the early glomerular lesions of DN will be demonstrable after 5 years in kidneys exposed to diabetes for a short duration, while in patients with long-standing type 1 D and more advanced glomerular DN lesions, longer exposure to euglycemia is necessary to demonstrate arrest or regression of the lesions.
| Condition |
|---|
|
Diabetes Mellitus |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | "Ii-Pancreas Transplantation in Man", "Long Term Effects of Cyclosporine (CSA) and Tacrolimus (FK506) on Renal Structure and Function", "Studies of the Renal Interstitium Type I Diabetic Patients", |
Skin Fibroblasts, Plasma and Serum samples, Urine samples, kidney biopsy culture samples.
| Estimated Enrollment: | 1000 |
| Study Start Date: | January 1981 |
| Estimated Study Completion Date: | August 2014 |
These continuation studies focus on large pancreas (PTx) and kidney (KTx) transplant populations of type 1 diabetic (D) patients (pts) in order to better understand diabetic nephropathy (DN), the leading cause of renal failure. Objectives are: (a) to determine whether PTx can more readily arrest or reverse the early vs. the more established lesions of DN; (b) to continue studies of renal structural-functional relationships in DN, with emphasis on the multifaceted pathologic DN lesions, including glomerular, vascular, interstitial lesions and glomerular-tubular connections; (c) to continue studies of DN natural history and the role of renal biopsy in predicting outcome; (d) to quantitate and understand the basis of atubular glomeruli (AG) in DN; (e) to elucidate glomerular (glom) epithelial cell abnormalities in DN; (f) to study the glom extracellular matrix abnormalities of DN; (g) to study the recurrence of DN in the KTx; (h) to study the molecular/genetic basis of DN and develop cellular markers of DN risk; (i) to determine the long-term (10-15 yr) structural consequences of cyclosporine (CSA) on the native kidneys of PTx recipients; and (j) to determine the shorter-term (5 yr) consequences of Prograf on the native kidneys of PTx recipients and compare these with those seen after 5 years of CSA treatment. Together, these studies will help to elucidate the pathogenesis and natural history of DN, unravel some of the molecular and genetic aspects of this disease, describe the dynamics of DN reversal in PTx pts, and recurrence in KTx pts and expand our knowledge of the nephrotoxic effects of calcinosis inhibitors.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
This is not a study that recruits from the general population. This study is selectively offered to eligible patients who are scheduled for a Pre-pancreas Transplant evaluation visit at the University of Minnesota Medical Center, Fairview Transplant Center. If interested in learning more, contact the Transplant Center for more information.
Inclusion Criteria:
Exclusion Criteria:
Pancreas Transplantation Alone
Pancreas Transplantation After Kidney Transplantation
Contacts and Locations| Contact: Cathy A Bagne, BS | 612-624-4688 | pinth001@umn.edu |
| Contact: Ashley Kinneberg, BS | 612-626-5552 | kinne0121@umn.edu |
| United States, Minnesota | |
| Universtity of Minnesota, Department of Pediatric Nephrology | Recruiting |
| Minneapolis, Minnesota, United States, 55455 | |
| Principal Investigator: | Michael S Mauer, MD | Pediatric Nephrology, University of Minnesota |
| Study Director: | Arthur J Matas, MD | University of MN, School of Medicine, Dept of Surgery |
More Information
| Responsible Party: | University of Minnesota Medical Center, Fairview ( Michael Mauer, MD Principal Investigator ) |
| Study ID Numbers: | 8107M00116, NIH 2P01-DK13083-38 |
| Study First Received: | September 7, 2005 |
| Last Updated: | January 27, 2010 |
| ClinicalTrials.gov Identifier: | NCT00156364 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Diabetic Nephropathy Kidney Transplant Pancreas Transplant Renal Interstitium |
Diabetes Mellitus Cyclosporine Tacrolimus |
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Metabolic Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders |