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

This study is not yet open for participant recruitment.
Verified May 2011 by Vancouver Coastal Health
Sponsor:
Information provided by:
Vancouver Coastal Health
ClinicalTrials.gov Identifier:
NCT01123122
First received: May 13, 2010
Last updated: May 16, 2011
Last verified: May 2011
History of Changes
  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 Blind (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:

Drug Information available for: Dextrose
U.S. FDA Resources

Further study details as provided by Vancouver Coastal Health:

Primary Outcome Measures:
  • Islet cell function [ Time Frame: Three months ] [ Designated as safety issue: No ]
    Function will be assessed three months post-transplantation.


Estimated Enrollment: 32
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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01123122

Contacts
Contact: Trina L McIlhargey, MD PhD trina@ualberta.net

Locations
Canada, British Columbia
Vancouver General Hospital Not yet recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Trina L McIlhargey, MD PhD         trina@ualberta.net    
Principal Investigator: David M Thompson, MD            
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
Study First Received: May 13, 2010
Last Updated: May 16, 2011
Health Authority: Canada: Ethics Review Committee

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

ClinicalTrials.gov processed this record on May 23, 2013