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Does Islet Transplantation Eliminate Hypoglycemia?

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2001 by National Center for Research Resources (NCRR).
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00006068
First Posted: July 19, 2000
Last Update Posted: December 9, 2005
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.
Information provided by:
National Center for Research Resources (NCRR)
  Purpose
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 Intervention
Diabetes Mellitus Procedure: Pancreatic Islet Transplantation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Masking: Single
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by National Center for Research Resources (NCRR):

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Clinically stable, insulin dependent islet transplant recipients and matched nondiabetic healthy controls
  Contacts and Locations
Information from the National Library of Medicine

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 ClinicalTrials.gov identifier (NCT number): NCT00006068


Contacts
Contact: Philip E. Cryer, M.D. 1-314-362-7635 pcryer@imgate.wustl.edu

Sponsors and Collaborators
National Center for Research Resources (NCRR)
  More Information

ClinicalTrials.gov Identifier: NCT00006068     History of Changes
Other Study ID Numbers: NCRR-M01RR00036-0746
M01RR000036 ( U.S. NIH Grant/Contract )
First Submitted: July 18, 2000
First Posted: July 19, 2000
Last Update Posted: December 9, 2005
Last Verified: November 2001

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