Ignite Creation Date:
2024-05-06 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04690309
Status:
UNKNOWN
Last Update Posted:
2021-01-05
First Post:
2020-12-22
Brief Title:
Human Versus Analogue Insulin in Patients After Pancreatectomy
Sponsor:
Polish Society of Diabetology
Organization:
Polish Society of Diabetology
Study Overview
Official Title:
Human Versus Analogue Insulin in Patients After Pancreatectomy - Open Prospective Randomized Intervention Study
Status:
UNKNOWN
Status Verified Date:
2020-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patientsThe 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 studyAll 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 mgdl and with prandial insulin when 2-hour postprandial plasma glucose exceeded 180 mgdlThe patients who required insulin treatment after surgery were randomized with the use of random numbers generator wwwrandomizerorg into two groups Group 1 - treated with insulin analogues lispro glargine Group 2 - treated with human insulin preparations regular and NPH insulinThe clinical and metabolic assessment was carried out 3 and 6 months after surgery The study was approved by Local Ethics Committee
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None