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Islet Function and Clinical Analyses of Transplant Recipients

NCT ID: NCT00870831

Last Updated: 2014-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

8 participants

Study Classification

OBSERVATIONAL

Study Start Date

2000-10-31

Study Completion Date

2010-03-31

Brief Summary

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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

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Conditions

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Type One Diabetes Mellitus

Keywords

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diabetes

Study Design

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Observational Model Type

COHORT

Study Groups

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Islet Recipient

Subjects that have successfully received and maintained an Islet transplant at Washington University Center for Islet Transplantation

OGTT (Oral Glucose Tolerance Test)

Intervention Type 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

Control

subjects that were similar in height, weight and age that did NOT have diabetes to act as the comparative group

OGTT (Oral Glucose Tolerance Test)

Intervention Type 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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kenneth S Polonsky, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Daniel C Brennan, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Countries

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United States

Other Identifiers

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00-0870

Identifier Type: -

Identifier Source: org_study_id