- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00018122
Patterns and Natural History of Insulin Secretion in Islet Cell Transplant Recipients and Controls
Patterns and Natural History of Insulin Secretion in Islet Cell Transplant Recipients and Controls (Project 2 of JDFI Washington University Center for Islet Transplantation, KS Polonsky, PI)
Study Overview
Status
Conditions
Detailed Description
If Islet Cell transplants are to become a reasonable treatment alternative for patients with type 1 diabetes, there must be knowledge about how the islet cells function after transplant {islet cells are responsible for making the insulin the body needs in order to control blood sugar). This knowledge would allow for improvements in the islet cell transplant procedure itself, as well as possible alterations of the immunosuppressive medications (drugs that prevent rejection) that are prescribed. There are two basic kinds of diabetes, type 1 (formally known as Insulin Dependent or Juvenile diabetes) and type 2 (formally known as Adult-Onset or Non-insulin dependent) diabetes. The patients in this study will be affected by type 1 diabetes. After the transplant, it is hoped they will no longer need insulin injections. It is possible patients may need to take pioglitazone and/or metformin, however, this will be prescribed in Project 1, if needed.
The medications used for this study include: C-peptide. This is a synthetic product (not from human or animal sources) that is man-made and identical to the C-peptide made by the body. C-peptide is made at the same time as insulin, one molecule of insulin equals one molecule C-peptide. By giving C-peptide that is synthetic, researchers can measure how the C-peptide breaks down in the body, which could then be related to how insulin breaks down in the body. Somatostatin will also be used during the same test as the C-peptide. While receiving Somatostatin, the production of insulin by the patient will be stopped. This medication will only be given for 4 hours and the blood sugar will be monitored during the entire procedure. Insulin & Glucose will also be given by IV during certain tests to regulate the blood sugar. Blood sugars will be maintained within a certain level and this will be achieved through the administration of insulin and/or glucose. The patient's blood sugar will be monitored at frequent intervals throughout the various procedures.
Study Type
Contacts and Locations
Study Locations
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Missouri
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St. Louis, Missouri, United States, 63110
- Washington University School of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Collaborators
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- NCRR-M01RR00036-0779
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