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NCT00006068 Clinical Trial

Does Islet Transplantation Eliminate Hypoglycemia?

Diabetes Mellitus Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT00006068
Other study ID # NCRR-M01RR00036-0746
Secondary ID M01RR000036
Status Not yet recruiting
Phase N/A
First received July 18, 2000
Last updated June 23, 2005

Study information
Verified date November 2001
Source National Center for Research Resources (NCRR)
Contact Philip E. Cryer, M.D.
Phone 1-314-362-7635
Email pcryer@imgate.wustl.edu
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

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

Study Design

Allocation: Non-Randomized, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Pancreatic Islet Transplantation

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
National Center for Research Resources (NCRR)
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