Islet Transplantation in Type 1 Diabetic Patients
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ClinicalTrials.gov Identifier: NCT00214253 |
Recruitment Status
:
Completed
First Posted
: September 21, 2005
Last Update Posted
: March 31, 2017
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Type 1 Diabetes | Drug: Thiazolidinedione | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 14 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Islet Transplantation in Type 1 Diabetic Patients Using a Steroid-free Immunosuppression Protocol and Thiazolidinedione Insulin Sensitizers |
Study Start Date : | February 2002 |
Actual Primary Completion Date : | October 2011 |
Actual Study Completion Date : | October 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
Thiazolidinedione therapy
|
Drug: Thiazolidinedione
Thiazolidinedione vs. no intervention with standard immunosuppression using Edmonton Protocol
|
No Intervention: 2 |
- number of islets necessary to achieve adequate metabolic control [ Time Frame: 5 years ]
- post-transplant islet function [ Time Frame: 5 years ]
- Suitability of cadaver donor pancreases for islet transplantation [ Time Frame: 5 years ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 16 Type I insulin-dependent diabetic subjects ages 18-60,(8 who have received a prior kidney or liver transplant and have stable renal function, and 8 who have labile glucose regulation and who have failed a trial of intensive exogenous insulin therapy and who have preserved native renal function)
Exclusion Criteria:
- untreated proliferative diabetic retinopathy;
- HgbA1C >12%; creatinine clearance < 80 ml/minute or macroalbuminuria > 0.3 gm/24 hrs;
- presence of panel reactive antibodies >20%

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00214253
United States, Wisconsin | |
University of Wisconsin | |
Madison, Wisconsin, United States, 53792 |
Principal Investigator: | Jon Odorico, MD | University of Wisconsin, Madison |
Responsible Party: | University of Wisconsin, Madison |
ClinicalTrials.gov Identifier: | NCT00214253 History of Changes |
Other Study ID Numbers: |
2001-529 |
First Posted: | September 21, 2005 Key Record Dates |
Last Update Posted: | March 31, 2017 |
Last Verified: | March 2017 |
Additional relevant MeSH terms:
Diabetes Mellitus, Type 1 Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Autoimmune Diseases Immune System Diseases 2,4-thiazolidinedione Hypoglycemic Agents Physiological Effects of Drugs |