Islet Function and Clinical Analyses of Transplant Recipients

NCT00870831 | Terminated

• 1 other identifier: 00-0870
• Study Type: observational
• Target: 8
• Locations: 0 countries
• Sites: N/A

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

Conditions

Type One Diabetes Mellitus

Keywords

diabetes

Outcome Measures

Primary Outcomes (1)

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

  5 years

Secondary Outcomes (1)

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

  5yrs

Study Arms (2)

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)

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)

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

Control; Islet Recipient

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• well controlled Type 1 diabetes
• transplant failure
• unable to match potential subject to a recipient

Sponsors & Collaborators

• Washington University School of Medicine: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples are obtained during the OGTT and stored in a -20degree freezer. They are tested for Insulin C-peptide and glucose.

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Glucose Tolerance Test

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Investigative Techniques

Study Officials

• Kenneth S Polonsky, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

• Daniel C Brennan, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2009
• First Posted: March 27, 2009
• Study Start: October 1, 2000
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: December 10, 2014

Record last verified: 2014-12