Phase
Condition
Diabetes Prevention
Pancreatitis
Diabetes And Hypertension
Treatment
Normal Volunteers
Intrahepatic islets alone
Intrahepatic islets and islets in the omental pouch
Clinical Study ID
Ages 18-68 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age 18-68
Scheduled for total pancreatectomy and IAT at U of MN. All patients who are approvedfor pancreatectomy and IAT at U of MN are reviewed by a multi-disciplinary committeeincluding surgeons, gastroenterologists specializing in pancreatic disease, a painspecialist psychologist, and endocrinologist to confirm the diagnosis of chronicpancreatitis and candidate suitability for surgery.
Able to provide informed consent
Exclusion
Exclusion Criteria:
Pre-Existing diabetes mellitus fasting blood glucose>115mg/dl, or hemoglobin A1clevel >6.0% because these are all evidence of inadequate beta-cello mass.
Use of any of the following treatments in the 30 days prior to enrollment: insulin,metformin, sulfonylureas, glinides, thiazolidinediones, GLP-1 agonists, DPP-4inhibitors, or amylin.
ALT or AST>2.5 times the upper limit of normal (ULN). Bilirubin>ULN, unless due tobenign diagnosis such as Gilbert's.
Any of the following hematologic abnormalities: server anemia (hemoglobin <10 g/dL),thrombocytopenia (<150/mm3), or neutropenia(<1.0 x 109/L).
Current use or expected use of oral or injected corticosteroids, or any mediationlikely to affect glucose tolerance. However, use of hydrocortisone for physiologicreplacement, or use of any topical, inhaled or intranasal glucocorticoid ispermitted.
Current or expected use of any other immunosuppressive agent.
Known coagulopathy, or need for anticoagulant therapy preoperatively (coumadin,enoxaparin), or any history of pulmonary embolism.
For females, plans to become pregnant or unwillingness to use birth control for thestudy duration.
Inability to comply with the study protocol.
Untreated psychiatric illness that may interfere with ability to give informedconsent, or other developmental delay or neurocognitive disorder that impairs with apatient's ability to consent on their own behalf.
Any other medical condition that , in the opinion of the investigator, may interferewit the patient's ability to successfully and safely complete the trial.
Study Design
Study Description
Connect with a study center
University of Minnesota
Minneapolis, Minnesota 55455
United StatesSite Not Available
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