Islet Function and Clinical Analyses of Transplant Recipients

Washington University School of Medicine8 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Type One Diabetes Mellitus

Interventions

OGTT (Oral Glucose Tolerance Test)OTHER

Subjects would consume 75grams of sugar (Dextrose, 10 oz) and blood samples taken at specified time points to measure glucose, insulin and C-peptide

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 5 years

Secondary Outcomes

The OGTT reflects the function of the Islet transplant and could be used as an indication of Islet Transplant function

Time frame: 5yrs

Data from ClinicalTrials.gov

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