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Does Islet Transplantation Eliminate Hypoglycemia?

Sponsor
National Center for Research Resources (NCRR) (NIH)
Overall Status
Unknown status
CT.gov ID
NCT00006068
Collaborator
(none)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Pancreatic Islet Transplantation
 N/A

Study Design

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

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Clinically stable, insulin dependent islet transplant recipients and matched nondiabetic healthy controls

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • National Center for Research Resources (NCRR)

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00006068
    Other Study ID Numbers:
    • NCRR-M01RR00036-0746
    • M01RR000036
    First Posted:
    Jul 19, 2000
    Last Update Posted:
    Jun 24, 2005
    Last Verified:
    Nov 1, 2001

    Study Results

    No Results Posted as of Jun 24, 2005