Patterns and Natural History of Insulin Secretion in Islet Cell Transplant Recipients and Controls

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00018122
Recruitment Status : Unknown
Verified December 2003 by National Center for Research Resources (NCRR).
Recruitment status was:  Active, not recruiting
First Posted : July 5, 2001
Last Update Posted : June 28, 2005
Juvenile Diabetes Research Foundation
Information provided by:
National Center for Research Resources (NCRR)

Brief Summary:
This grant is to study patients that have received a kidney transplant AND an Islet Cell transplant and to discover how the transplant is functioning. We will seek to have several patients who have had a kidney transplant but do NOT have either type of diabetes. These patients will serve as the "control group" since they will also be on immunosuppressive medications but are not affected by abnormal blood sugars. This will allow investigators to develop an understanding of how these immunosuppressive medications affect glucose metabolism (blood sugar levels) and insulin utilization (how the body uses insulin).

Condition or disease
Diabetes Mellitus

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 : Observational
Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: 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)

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Type 1 diabetics that have received a kidney transplant as well as (under Project 1) Islet Cell Transplant. A control group of 8 kidney transplant recipients who do not have diabetes will also be sought. Age range for both groups is expected to fall in the 25-50 year/old range based upon statistical data, although those between the ages of 18 and 65 may also qualify.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00018122

United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
National Center for Research Resources (NCRR)
Juvenile Diabetes Research Foundation Identifier: NCT00018122     History of Changes
Other Study ID Numbers: NCRR-M01RR00036-0779
First Posted: July 5, 2001    Key Record Dates
Last Update Posted: June 28, 2005
Last Verified: December 2003

Keywords provided by National Center for Research Resources (NCRR):
Islet cell transplant

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