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Does Islet Transplantation Eliminate Hypoglycemia?
This study is not yet open for participant recruitment.
Verified by National Center for Research Resources (NCRR), November 2001
Sponsored by: National Center for Research Resources (NCRR)
Information provided by: National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier: NCT00006068
  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

MedlinePlus related topics: Diabetes Hypoglycemia Islet Cell Transplantation
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Single Blind
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Clinically stable, insulin dependent islet transplant recipients and matched nondiabetic healthy controls
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006068

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

Sponsors and Collaborators
  More Information

Study ID Numbers: NCRR-M01RR00036-0746, M01RR00036
Study First Received: July 18, 2000
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00006068  
Health Authority: United States: Federal Government

Study placed in the following topic categories:
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Hypoglycemia

ClinicalTrials.gov processed this record on January 16, 2009