Islet Transplantation in Type 1 Diabetic Patients

NCT00214253 | Completed Phase 1

• 1 other identifier: 2001-529
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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?

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (2)

• number of islets necessary to achieve adequate metabolic control

  5 years

• post-transplant islet function

  5 years

Secondary Outcomes (1)

• Suitability of cadaver donor pancreases for islet transplantation

  5 years

Study Arms (2)

1

EXPERIMENTAL

Thiazolidinedione therapy

Drug: Thiazolidinedione

2

NO INTERVENTION

Interventions

Thiazolidinedione DRUG

Thiazolidinedione vs. no intervention with standard immunosuppression using Edmonton Protocol

1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• untreated proliferative diabetic retinopathy;
• HgbA1C \>12%; creatinine clearance \< 80 ml/minute or macroalbuminuria \> 0.3 gm/24 hrs;
• presence of panel reactive antibodies \>20%

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

2,4-thiazolidinedione

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Jon Odorico, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: September 21, 2005
• Study Start: February 1, 2002
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: March 31, 2017

Record last verified: 2017-03

Locations

US (1)