Assessing and predicting functional and quality of life-related outcomes of islet and pancreatic transplantation in patients with type 1 diabetes mellitus
Phase 4
Completed
- Conditions
- Diabetestransplantation100126531003717310014705
- Registration Number
- NL-OMON43807
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 26
Inclusion Criteria
Accepted for either islet or whole pancreas transplantation at the LUMC or post transplantation.
Received either islet or whole pancreas tranplantation at the LUMC and are currently follow up by mixec meal tolerance test
Exclusion Criteria
-Severe cognitive or psychiatric impairment
-Unable to adequately understand the Dutch language
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The study endpoint for the first objective is allograft function (as assessed<br /><br>by mixed meal test and beta score) at 1 and 5 years, together with serum beta<br /><br>cell damage markers </p><br>
- Secondary Outcome Measures
Name Time Method <p>Quality of life<br /><br>Hypoglycemia burden</p><br>