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Does Islet Transplantation Eliminate Hypoglycemia?

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ClinicalTrials.gov 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
Sponsor:
Information provided by:
National Center for Research Resources (NCRR)

July 18, 2000
July 19, 2000
June 24, 2005
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No Changes Posted
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Does Islet Transplantation Eliminate Hypoglycemia?
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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.
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Interventional
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Allocation: Non-Randomized
Masking: Single
Primary Purpose: Treatment
Diabetes Mellitus
Procedure: Pancreatic Islet Transplantation
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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Inclusion Criteria:

  • Clinically stable, insulin dependent islet transplant recipients and matched nondiabetic healthy controls
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
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NCT00006068
NCRR-M01RR00036-0746
M01RR000036 ( U.S. NIH Grant/Contract )
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National Center for Research Resources (NCRR)
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National Center for Research Resources (NCRR)
November 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP