UVA Islet Cell Transplantation in Patients With Type I Diabetes - Tabular View

Tracking Information

First Received Date ^ICMJE

January 18, 2008

Last Updated Date

February 16, 2009

Start Date ^ICMJE

January 2007

Estimated Primary Completion Date

January 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

A decrease in the average daily insulin requirement post-islet cell transplantation. [ Time Frame: Post-transplant ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00605592 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

UVA Islet Cell Transplantation in Patients With Type I Diabetes

Official Title ^ICMJE

UVA Islet Cell Transplantation in Patients With Type I Diabetes

Brief Summary

This protocol will provide islet cell transplantation to two separate populations in need of a pancreas transplant:

Group I: Islet Cell Transplantation in Type I Diabetics without Kidney Problems

Group II: Islet Cell Transplantation in Type I Diabetics Who Have a Stable Functioning Kidney Transplant

The targeted patients have very brittle diabetes or dangerous hypoglycemic unawareness and may benefit from transplantation over continuing insulin therapy, even though chronic immunosuppression is required. We believe that in these patients, the islet transplant procedure promises enough potential benefit to justify subjecting patients who have not previously had a transplant to the risk of immunosuppression.

In patients who are already subject to the dangers of chronic immunosuppression for other reasons, i.e. to prevent rejection of a kidney allograft, the islet transplantation procedure itself is the principal additional risk and this risk should be minimal. In these patients (our Group II), the potential benefit from improved glycemic control is that it promises to slow or even reverse diabetic complications, such as vascular problems leading to kidney damage. It is this rationale that has made pancreas transplantation a widely accepted option in patients with renal failure, despite the risks associated with whole pancreas transplantation. Islet cell transplantation aims to provide a potentially lower risk procedure that has similar relief from diabetic complications.

Detailed Description

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Single Group Assignment

Condition ^ICMJE

Diabetes Mellitus, Type 1

Intervention ^ICMJE

Procedure: Pancreatic Islets of Langerhans Cell Transplant

Study Arms / Comparison Groups

Experimental: Islet cell transplant

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

January 2012

Estimated Primary Completion Date

January 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Type I Diabetes Mellitus for at least 5 years
Unstable control of diabetes despite intensive care by an endocrinologist, including episodes of dangerously low blood sugars
Group I must have healthy kidneys
Group II (islet after kidney) must have a stable kidney allograft for at least 6 months

Exclusion Criteria:

Unstable diabetic eye disease
Poor kidney function
Type II Diabetes as determined by blood tests
Any history of cancer, except certain skin cancers
Pregnant or unwilling to use adequate birth control
Very high hemoglobin A1c levels
Poor control of blood pressure, despite use of medications
Very high insulin requirements
History of exposure to HIV
Active Hepatitis B or Hepatitis C infection

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00605592

Responsible Party

Kenneth Brayman/MD, PhD, University of Virginia

Study ID Numbers ^ICMJE

12839

Study Sponsor ^ICMJE

University of Virginia

Collaborators ^ICMJE

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Wyeth

Investigators ^ICMJE

Principal Investigator:

Kenneth Brayman, MD, PhD

University of Virginia

Information Provided By

University of Virginia

Verification Date

February 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP