Islet Transplantation in Type 1 Diabetic Patients
Primary Purpose
Type 1 Diabetes
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Thiazolidinedione
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes
Eligibility Criteria
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%
Sites / Locations
- University of Wisconsin
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
1
2
Arm Description
Thiazolidinedione therapy
Outcomes
Primary Outcome Measures
number of islets necessary to achieve adequate metabolic control
post-transplant islet function
Secondary Outcome Measures
Suitability of cadaver donor pancreases for islet transplantation
Full Information
NCT ID
NCT00214253
First Posted
September 14, 2005
Last Updated
March 29, 2017
Sponsor
University of Wisconsin, Madison
1. Study Identification
Unique Protocol Identification Number
NCT00214253
Brief Title
Islet Transplantation in Type 1 Diabetic Patients
Official Title
Islet Transplantation in Type 1 Diabetic Patients Using a Steroid-free Immunosuppression Protocol and Thiazolidinedione Insulin Sensitizers
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
February 2002 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
4. Oversight
5. Study Description
Brief Summary
Our hypothesis is that a successful clinical islet transplant program can be established at the University of Wisconsin using a steroid -free, sirolimus- and low dose tacrolimus - based immunosuppressive drug regimen (Edmonton protocol). We intend to answer the following research questions: 1) will treatment of islet transplant recipients with thiazolidinediones (i.e. pioglitazone) enhance post-transplant islet function and reduce the number of islets necessary to achieve adequate metabolic control? 2) which type 1 diabetic patients are optimal candidates for islet transplantation (i.e. islet transplant alone or islet after kidney transplantation)? 3) Can cadaver donor pancreases, which are ordinarily discarded and not used for pancreas transplantation be used for islet transplantation?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Thiazolidinedione therapy
Arm Title
2
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Thiazolidinedione
Intervention Description
Thiazolidinedione vs. no intervention with standard immunosuppression using Edmonton Protocol
Primary Outcome Measure Information:
Title
number of islets necessary to achieve adequate metabolic control
Time Frame
5 years
Title
post-transplant islet function
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Suitability of cadaver donor pancreases for islet transplantation
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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%
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon Odorico, MD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
12. IPD Sharing Statement
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Islet Transplantation in Type 1 Diabetic Patients
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