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A Comparison of Strict Glucose Control With Usual Care at the Time of Islet Cell Transplantation

Primary Purpose

Diabetes Mellitus, Type 1, Islet Transplantation

Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Strict glucose control
Sponsored by
Vancouver Coastal Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 to 65 years of age
  • more than 5 years since diagnosis of diabetes
  • c-peptide negative

Exclusion Criteria:

  • ischemic heart disease
  • previous transplant
  • recurrent infections
  • malignancy (except basal or squamous skin cancer)

Sites / Locations

  • Vancouver General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Strict glucose control

Standard glucose control

Arm Description

Outcomes

Primary Outcome Measures

Islet cell function
Function will be assessed three months post-transplantation.

Secondary Outcome Measures

Full Information

First Posted
May 13, 2010
Last Updated
March 31, 2015
Sponsor
Vancouver Coastal Health
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1. Study Identification

Unique Protocol Identification Number
NCT01123122
Brief Title
A Comparison of Strict Glucose Control With Usual Care at the Time of Islet Cell Transplantation
Official Title
A Comparison of Strict Glucose Control With Usual Care at the Time of Islet Cell Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Withdrawn
Study Start Date
September 2011 (undefined)
Primary Completion Date
September 2015 (Anticipated)
Study Completion Date
September 2015 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Vancouver Coastal Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Islet transplants for those with type 1 diabetes have enabled many to initially eliminate insulin, however, only a fraction of the transplanted cells typically survive and the functioning of these decrease over time. As a result, most patients will eventually require some insulin. Currently, the cause of this poor survival and decrease in function is not understood; although previous research has demonstrated that even a slightly elevated level of blood glucose can impair islet function. This study will determine if strict blood glucose control at the time of islet transplantation, when the cells are the most fragile, will improve the survival and functioning of transplanted islet cells three months after transplantation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1, Islet Transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Strict glucose control
Arm Type
Active Comparator
Arm Title
Standard glucose control
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Strict glucose control
Intervention Description
Blood glucose level to be maintained at 4-6 mmol/L at the time of islet transplantation until two weeks post-transplantation.
Primary Outcome Measure Information:
Title
Islet cell function
Description
Function will be assessed three months post-transplantation.
Time Frame
Three months

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: 18 to 65 years of age more than 5 years since diagnosis of diabetes c-peptide negative Exclusion Criteria: ischemic heart disease previous transplant recurrent infections malignancy (except basal or squamous skin cancer)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David M Thompson, MD
Organizational Affiliation
Vancouver General Hospital Department of Endocrinology and Metabolism
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada

12. IPD Sharing Statement

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A Comparison of Strict Glucose Control With Usual Care at the Time of Islet Cell Transplantation

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