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

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01123122
First Posted: May 14, 2010
Last Update Posted: April 1, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Vancouver Coastal Health
  Purpose
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.

Condition Intervention
Diabetes Mellitus, Type 1 Islet Transplantation Other: Strict glucose control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Comparison of Strict Glucose Control With Usual Care at the Time of Islet Cell Transplantation

Resource links provided by NLM:


Further study details as provided by Vancouver Coastal Health:

Primary Outcome Measures:
  • Islet cell function [ Time Frame: Three months ]
    Function will be assessed three months post-transplantation.


Enrollment: 0
Study Start Date: September 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Strict glucose control Other: Strict glucose control
Blood glucose level to be maintained at 4-6 mmol/L at the time of islet transplantation until two weeks post-transplantation.
No Intervention: Standard glucose control

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Information from the National Library of Medicine

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): NCT01123122


Locations
Canada, British Columbia
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
Sponsors and Collaborators
Vancouver Coastal Health
Investigators
Principal Investigator: David M Thompson, MD Vancouver General Hospital Department of Endocrinology and Metabolism
  More Information

Publications:

Responsible Party: David M. Thompson, Vancouver General Hospital Department of Endocrinology and Metabolism
ClinicalTrials.gov Identifier: NCT01123122     History of Changes
Other Study ID Numbers: VGHEndo0510
First Submitted: May 13, 2010
First Posted: May 14, 2010
Last Update Posted: April 1, 2015
Last Verified: May 2011

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases