A Comparison of Strict Glucose Control With Usual Care at the Time of Islet Cell Transplantation
- Conditions
- Diabetes Mellitus, Type 1Islet Transplantation
- Interventions
- Other: Strict glucose control
- Registration Number
- NCT01123122
- Lead Sponsor
- Vancouver Coastal Health
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 18 to 65 years of age
- more than 5 years since diagnosis of diabetes
- c-peptide negative
- ischemic heart disease
- previous transplant
- recurrent infections
- malignancy (except basal or squamous skin cancer)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Strict glucose control Strict glucose control -
- Primary Outcome Measures
Name Time Method Islet cell function Three months Function will be assessed three months post-transplantation.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Vancouver General Hospital
🇨🇦Vancouver, British Columbia, Canada