Pancreatogenous Diabetes
Conditions
Keywords
human insulin, insulin analogues
Brief 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.
Interventions
DRUGTreatment with human insulin preparations or treatment with insulin analogues
The doses of human insulin preparations and insulin analogues will be matched individually to achieve target values of blood glucose - fasting \< 100 mg/dl (5.5 mmol/L) and postprandial \< 140 mg/dl (7.8mmol/L)
Sponsors
Polish Society of Diabetology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 90 Years
Healthy volunteers
No
Inclusion criteria
•Patients with pancreatic tumor confirmed in imaging studies and qualified for surgical treatment
Exclusion criteria
•Active psychiatric disease not amenable to treatment and hindering cooperation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Metabolic control in patients treated with human insulin preparations insulin vs insulin analogues. | Change in concentration of glycated hemoglobin from baseline to concentration of glycated hemoglobin 6 months after surgery in patients treated with human insulin and insulin analogues | Metabolic control in patients treated with human insulin and insulin analogues will be assessed using glycated hemoglobin concentration (mmol/mol) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Metabolic control in patients treated with human insulin preparations insulin vs insulin analogues. | Change in concentration of glycated hemoglobin from baseline to concentration of glycated hemoglobin 3 months after surgery in patients treated with human insulin and insulin analogues | Metabolic control in patients treated with human insulin and insulin analogues will be assessed using glycated hemoglobin concentration (mmol/mol) |
Countries
Poland
Contacts
Primary ContactJolanta B Jurczyńska, PhD
Outcome results
None listed