Human Versus Analogue Insulin in Patients After Pancreatectomy.
Status:
Recruiting
Trial end date:
2021-12-31
Target enrollment:
Participant gender:
Summary
Pancreatectomy is a common treatment modality for both benign and malignant pathologies. One
of the most common complications after pancreatectomy is pancreatogenous diabetes mellitus.
Yet, insulin remains treatment of choice in patients after pancreatectomy, however there is
little evidence on the choice of insulin preparation in patients with diabetes after
pancreatectomy. In particular, it is unclear whether human or analogue insulin should be
preferred in this group of patients.The aim of the study was to compare human vs analog
insulin therapy in patients with diabetes prior to or diabetes developing after
pancreatectomy performed due to pancreatic tumor. The study was designed as an open,
prospective, randomized, intervention study.All patients provided written comprehensive
informed consent. After surgery all patients who underwent total pancreatectomy were treated
with insulin, while the patients who had partial pancreatectomy performed were treated with
basal insulin when fasting plasma glucose exceeded 140 mg/dl and with prandial insulin when
2-hour postprandial plasma glucose exceeded 180 mg/dl.The patients who required insulin
treatment after surgery were randomized with the use of random numbers generator
(www.randomizer.org) into two groups: Group 1 - treated with insulin analogues (lispro,
glargine), Group 2 - treated with human insulin preparations (regular and NPH insulin).The
clinical and metabolic assessment was carried out 3 and 6 months after surgery. The study was
approved by Local Ethics Committee.