Islet Function and Clinical Analyses of Transplant Recipients

Terminated

• Conditions: Type One Diabetes Mellitus

• 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

Study Timeline

• Study Start: 2000-10
• Study First Submitted: 2009-03-26
• Study First Submitted QC: 2009-03-26
• Study First Posted: 2009-03-27
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-08
• Last Update Posted: 2014-12-10

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

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