Islet Function and Clinical Analyses of Transplant Recipients (Islet OGTT)

Islet Function and Clinical Analyses if Transplant Recipients (Project 2 of JDFI Washington University Center For Islet Transplantation) (Please Note That the JDRFI Funded Has Ended

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

Study Overview

• Status: Terminated
• Conditions: Type One Diabetes Mellitus
• Intervention / Treatment: Other: OGTT (Oral Glucose Tolerance Test)

• Study Type: Observational
• Enrollment (Actual): 8

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Type 1 diabetics that have successfully received and maintained an islet transplant here at Washington University. Loss of transplant function is an exclusion criteria.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Islet Recipient; Subjects that have successfully received and maintained an Islet transplant at Washington University Center for Islet Transplantation	Other: OGTT (Oral Glucose Tolerance Test); Subjects would consume 75grams of sugar (Dextrose, 10 oz) and blood samples taken at specified time points to measure glucose, insulin and C-peptide
Control; subjects that were similar in height, weight and age that did NOT have diabetes to act as the comparative group	Other: OGTT (Oral Glucose Tolerance Test); Subjects would consume 75grams of sugar (Dextrose, 10 oz) and blood samples taken at specified time points to measure glucose, insulin and C-peptide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
OGTT will be performed every 6 months for 5 years in subjects with a functioning Islet Transplant	5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
The OGTT reflects the function of the Islet transplant and could be used as an indication of Islet Transplant function	5yrs

Collaborators and Investigators

• Sponsor: Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start: October 1, 2000
• Primary Completion (ACTUAL): March 1, 2010
• Study Completion (ACTUAL): March 1, 2010

Study Registration Dates

• First Submitted: March 26, 2009
• First Submitted That Met QC Criteria: March 26, 2009
• First Posted (ESTIMATE): March 27, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): December 10, 2014
• Last Update Submitted That Met QC Criteria: December 8, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: diabetes
• Other Study ID Numbers: 00-0870