Clinical trial NCT01123122: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Islet Transplantation
Lead sponsor: Vancouver Coastal Health
Sponsor class: OTHER_GOV
First posted: 2010-05-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Islet cell function
timeFrame: Three months
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
Study officials:
affiliation: Vancouver General Hospital Department of Endocrinology and Metabolism
name: David M Thompson, MD
role: PRINCIPAL_INVESTIGATOR
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