Diabetes Mellitus, Type 1, Islet Transplantation
Conditions
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.
Interventions
Blood glucose level to be maintained at 4-6 mmol/L at the time of islet transplantation until two weeks post-transplantation.
Sponsors
Vancouver Coastal Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Islet cell function | Three months | Function will be assessed three months post-transplantation. |
Countries
Canada
Outcome results
None listed