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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Washington University School of Medicine.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00870831
First received: March 26, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  Purpose

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


Condition Intervention
Type One Diabetes Mellitus
Other: OGTT (Oral Glucose Tolerance Test)

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • OGTT will be performed every 6 months for 5 years in subjects with a functioning Islet Transplant [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The OGTT reflects the function of the Islet transplant and could be used as an indication of Islet Transplant function [ Time Frame: 5yrs ] [ Designated as safety issue: Yes ]

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.


Enrollment: 8
Study Start Date: October 2000
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00870831

Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Kenneth S Polonsky, MD Washington University School of Medicine
Principal Investigator: Daniel C Brennan, MD Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Kenneth S. Polonsky,MD, Washington University
ClinicalTrials.gov Identifier: NCT00870831     History of Changes
Other Study ID Numbers: 00-0870
Study First Received: March 26, 2009
Last Updated: March 26, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 20, 2014