Islet Function and Clinical Analyses of Transplant Recipients

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00870831

Acronym

Islet OGTT

Enrollment

Registered

2009-03-27

Start date

2000-10-31

Completion date

2010-03-31

Last updated

2014-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type One Diabetes Mellitus

Keywords

diabetes

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

Interventions

OTHEROGTT (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

Study design

Observational model

COHORT

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026