Sitagliptin Therapy to Improve Outcomes After Islet Autotransplant
This trial is active, not recruiting.
|Sponsor||University of Minnesota - Clinical and Translational Science Institute|
|Start date||August 2010|
|End date||July 2015|
|Trial size||90 participants|
|Trial identifier||NCT01186562, 1006M83756|
The purpose of the study is to test the effects of sitagliptin on the need for insulin (the hormone that lowers blood sugars) by patients who receive a pancreatectomy and islet autotransplant for chronic pancreatitis.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator)|
time frame: 12 months
time frame: 12 and 18 months
Partial Graft Function
time frame: 12 months and 18 months
Male or female participants at least 18 years old.
Inclusion Criteria: - Age ≥18 years - Scheduled for total pancreatectomy and IAT at UM Exclusion Criteria: - Pre-existing diabetes mellitus or hyperglycemia with fasting glucose ≥115 mg/dl - Medical conditions which, in the opinion of the investigator, might impact islet function (e.g asthma or inflammatory disease requiring chronic systemic corticosteroids) - Significant renal disease: serum creatinine levels of >3.0 mg/dL in men and >2.5 mg/dL in women, or end-stage renal disease requiring hemodialysis or peritoneal dialysis. - For female subjects, plans to become pregnant or unwillingness to practice birth control for 18 months. - Islet yield <1,000 IE/kg body weight (exclusion for treatment with drug/placebo)
|Official title||A Double-Blind, Randomized, Placebo Controlled Intervention Study to Assess the Impact of Sitagliptin 100 mg/Day for 1 Year on Insulin Independence Following Pancreatectomy and Autoislet Transplantation|
|Principal investigator||Melena Bellin, MD|
|Description||At the current time, about one-third of patients are insulin independent (do not need to take insulin) after autotransplant, but the other two-thirds still need some insulin. Sitagliptin works by increasing the amount of a hormone called glucagon-like peptide 1, or GLP-1, in the body which then increases the amount of insulin that is made by the beta cells(the insulin producing cell of the islets). GLP-1 might also help protect beta cells from dying under stressful conditions and increase the production of new beta cells. The primary goal of this study is to see if taking sitagliptin for one year after islet autotransplant increases the number of patients who achieve and maintain insulin independence. Other goals of this study are to see if sitagliptin reduces the amount of insulin injections needed or helps the islets make more insulin.|
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