Clinical trial NCT01186562: Sitagliptin Therapy to Improve Outcomes After Islet Autotransplant
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pancreatitis
Diabetes
Keywords: Pancreatitis
Pancreatectomy
Islet autotransplant
Sitagliptin
Diabetes
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2010-08-23
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Insulin Independence
timeFrame: 12 months
Secondary outcomes:
measure: Insulin Independence
timeFrame: 18 months
measure: Area Under the Curve (AUC) C-peptide (ng/dL*Min)
timeFrame: 12 months
measure: AUC C-peptide
timeFrame: 18 months
measure: Acute C-peptide Response (ACR) to Glucose
timeFrame: 12 months
measure: Acute C-peptide Response (ACR) to Glucose
timeFrame: 18 months
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Melena Bellin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Harindhanavudhi T, Yang Y, Hodges JS, Pruett TL, Kirchner V, Beilman GJ, Bellin MD. Body Composition is Associated With Islet Function After Pancreatectomy and Islet Autotransplantation for Pancreatitis. J Clin Endocrinol Metab. 2021 Jan 23;106(2):e496-e506. doi: 10.1210/clinem/dgaa790.