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	Treatment or Intervention
Diabetes Mellitus	Procedure: Pancreatic Islet Transplantation

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

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

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

Study ID Numbers:  NCRR-M01RR00036-0746; M01RR00036
Record last reviewed:  November 2001
Last Updated:  October 13, 2004
Record first received:  July 18, 2000
ClinicalTrials.gov Identifier:  NCT00006068
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08