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Modification of the "Edmonton Protocol" to allow for successful islet transplantation from a single pancreas and extension of the "Edmonton Protocol" to kidney transplant recipients Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Modification of the "Edmonton Protocol" to allow for successful islet transplantation from a single pancreas and extension of the "Edmonton Protocol" to kidney transplant recipients conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Modification of the "Edmonton Protocol" to allow for successful islet transplantation from a single pancreas and extension of the "Edmonton Protocol" to kidney transplant recipients Clinical research trials and Modification of the "Edmonton Protocol" to allow for successful islet transplantation from a single pancreas and extension of the "Edmonton Protocol" to kidney transplant recipients medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Modification of the "Edmonton Protocol" to allow for successful islet transplantation from a single pancreas and extension of the "Edmonton Protocol" to kidney transplant recipients. Modification of the "Edmonton Protocol" to allow for successful islet transplantation from a single pancreas and extension of the "Edmonton Protocol" to kidney transplant recipients Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Modification of the "Edmonton Protocol" to allow for successful islet transplantation from a single pancreas and extension of the "Edmonton Protocol" to kidney transplant recipients clinical trial. Participants frequently get the best healthcare available for their Modification of the "Edmonton Protocol" to allow for successful islet transplantation from a single pancreas and extension of the "Edmonton Protocol" to kidney transplant recipients condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "M" Clinical Trials Conditions > Modification of the "Edmonton Protocol" to allow for successful islet transplantation from a single pancreas and extension of the "Edmonton Protocol" to kidney transplant recipients  Modification of the "Edmonton Protocol" to allow for successful islet transplantation from a single pancreas and extension of the "Edmonton Protocol" to kidney transplant recipients
Modification of the "Edmonton Protocol" to allow for successful islet transplantation from a single pancreas and extension of the "Edmonton Protocol" to kidney transplant recipients
For Condition: Diabetes Mellitus
Status: No longer recruiting
Sponsor(s): National Center for Research Resources (NCRR) , Juvenile Diabetes Research Foundation
Synopsis: The experience of the Edmonton Group with islet transplantation and use of the "Edmonton Protocol" provides much promise for T1DM patients. However, the need to use 2 or more donor pancreases to achieve freedom from insulin shots limits the widespread use of this protocol. Two classes of oral antidiabetic drugs improve insulin action and reduce the amount of insulin needed to have normal blood sugars. The first part of the proposed project (Group 1) will use these drugs in conjunction with the Edmonton Protocol to allow for successful islet transplantation from islets isolated from a single pancreas. The Edmonton Protocol is a treatment, not a cure. It requires the long-term use of powerful immunosuppressive drugs that are expensive and increase the risk of infection and cancer. T1DM patients who have a functioning kidney transplant already have to use immunosuppressive drugs, and they are still at risk of recurrent diabetic kidney disease and other complications of diabetes. Islet transplantation in these patients has only rarely been successful in the past in part because the usual immunosuppressive drugs used in kidney transplantation cause diabetes and actually harm the transplant kidney in other ways. The immunosuppressive drugs used in the Edmonton Protocol are less likely to cause diabetes and are also less harmful to the kidney. In the second part of this project (Group 2), we will transplant islets into kidney transplant patients after they have switched to the immunosuppressive medications used in the Edmonton Protocol. Even if some of the patients do not get islet transplants or still need insulin shots after islet transplantation, we expect to see improvement in kidney function and blood glucose control.
Details: We anticipate that successful islet transplantation will establish a group of islet cell transplant patients who have normal blood sugars and do not need insulin injections. Some of this group will have received a kidney transplant as well. All these patients will be studied in great detail along with other investigators in our islet cell program to understand better the mechanisms of efficacy and side effects of islet transplant and these new immunosuppressive drugs.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: Type 1 diabetes for > 5 years AND Hypoglycemia unawareness, not felt adequately by patient (glucose < 54mg/dL) in last 1.6 years, not otherwise explained, requiring outside help OR Metabolic lability/instability, characterized by hypoglycemia or ketoacidosis (>2 hospital < 12 mo), chaotic glucose profile (MAGE > 120mg/dL), disruption in lifestyle or danger to life, to self, to others OR Failure of intensive insulin management, as judged by an independent endocrinologist.
Total Enrollment:
Location and Contact Information:
Washington University School of Medicine
St. Louis, Missouri, 63110
United States
Additional Information:
Study ID Numbers: NCRR-M01RR00036-0775;
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00021580
Other Diabetes Mellitus Studies:
1. Krypton-Argon Regression of Neovascularization Study (KARNS)
2. Visceral Adiposity and CVD Risk in Women
3. Genetics of the Metabolic Syndrome in Japanese Americans
4. Women's Healthy Lifestyle Project: Cardiovascular Risk Factors and Menopause
5. Compare blood sugar level between Lantus in the morning and other insulins in Type 1 diabetes adolescents
Related Studies:
Other Diabetes Mellitus Clinical Trials
Other Missouri Clinical Trials
Other St. Louis Clinical Trials
Modification of the "Edmonton Protocol" to allow for successful islet transplantation from a single pancreas and extension of the "Edmonton Protocol" to kidney transplant recipients
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