Islet Function and Clinical Analyses of Transplant Recipients
Terminated
- Conditions
- Type One Diabetes Mellitus
- Interventions
- Other: OGTT (Oral Glucose Tolerance Test)
- Registration Number
- NCT00870831
- Lead Sponsor
- Washington University School of Medicine
- Brief Summary
To follow the patterns and natural history of Islet Transplant recipients (the ones that were involved in the Modified Edmonton Protocol) using oral glucose to check sugar levels as well as insulin and C-peptide over the course of 5 years
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 8
Inclusion Criteria
- Type 1 Diabetes with hypoglycemia unawareness that received a Islet Transplant here at Washington University
- "control" subjects were matched to the transplant recipients base upon age, height, weight, & race (and could not have diabetes)
Exclusion Criteria
- well controlled Type 1 diabetes
- transplant failure
- unable to match potential subject to a recipient
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Islet Recipient OGTT (Oral Glucose Tolerance Test) Subjects that have successfully received and maintained an Islet transplant at Washington University Center for Islet Transplantation Control OGTT (Oral Glucose Tolerance Test) subjects that were similar in height, weight and age that did NOT have diabetes to act as the comparative group
- Primary Outcome Measures
Name Time Method OGTT will be performed every 6 months for 5 years in subjects with a functioning Islet Transplant 5 years
- Secondary Outcome Measures
Name Time Method The OGTT reflects the function of the Islet transplant and could be used as an indication of Islet Transplant function 5yrs