Does Islet Transplantation Eliminate Hypoglycemia?

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: NCT00006068
Recruitment Status : Unknown
Verified November 2001 by National Center for Research Resources (NCRR).
Recruitment status was:  Not yet recruiting
First Posted : July 19, 2000
Last Update Posted : June 24, 2005
Information provided by:
National Center for Research Resources (NCRR)

Brief Summary:
Low blood sugar (hypoglycemia) is a recurrent problem for many people with diabetes. Successful transplantation of clusters (islets) of normal cells, that include those which produce the sugar-lowering hormone insulin, from the pancreas of a person who did not have diabetes into a person with diabetes should eliminate high blood sugar levels. We wish to determine if it will also eliminate low blood sugar. To do so we will give insulin to lower the blood sugar, measure the levels of the hormones that normally raise blood sugar levels (e.g., glucagon and epinephrine) and then stop the insulin and see if blood sugar levels return to normal. Because we anticipate that the transplanted islets will produce insulin, but not glucagon, this study may also tell us if regulated insulin production alone can prevent hypoglycemia in humans.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Procedure: Pancreatic Islet Transplantation Not Applicable

Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Masking: Single
Primary Purpose: Treatment

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Clinically stable, insulin dependent islet transplant recipients and matched nondiabetic healthy controls

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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): NCT00006068

Contact: Philip E. Cryer, M.D. 1-314-362-7635

Sponsors and Collaborators
National Center for Research Resources (NCRR) Identifier: NCT00006068     History of Changes
Other Study ID Numbers: NCRR-M01RR00036-0746
M01RR000036 ( U.S. NIH Grant/Contract )
First Posted: July 19, 2000    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: November 2001

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