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Does Islet Transplantation Eliminate Hypoglycemia?



Does Islet Transplantation Eliminate Hypoglycemia?

For Condition: Diabetes Mellitus
Status: Not yet recruiting
Sponsor(s): National Center for Research Resources (NCRR) ,
Synopsis: 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.
Details:
Eligibility:
Study Type:  Interventional, Treatment, Non-Randomized, Single Blind
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Clinically stable, insulin dependent islet transplant recipients and matched nondiabetic healthy controls
Total Enrollment: 

Location and Contact Information:


Additional Information:
Study ID Numbers:  NCRR-M01RR00036-0746;  M01RR00036
Study Start Date: 
Record last reviewed: November 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006068

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