Human Versus Analogue Insulin in Patients After Pancreatectomy - Open, Prospective, Randomized, Intervention Study.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Metabolic control in patients treated with human insulin preparations insulin vs insulin analogues.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 90 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with pancreatic tumor confirmed in imaging studies and qualified for surgical treatment
排除标准
- •Active psychiatric disease not amenable to treatment and hindering cooperation
研究组 & 干预措施
Patients treated with human insulin preparations
Treatment with human regular insulin administered subcutaneously before breakfast, lunch and supper and with Neutral Protamine Hagedorn insulin (isofane insulin) administered subcutaneously before sleep.
干预措施: Treatment with human insulin preparations or treatment with insulin analogues (Drug)
Patients treated with insulin analogues
Treatment with insulin analogues lispro administered subcutaneously before breakfast, lunch and supper and with glargine administered subcutaneously before sleep.
干预措施: Treatment with human insulin preparations or treatment with insulin analogues (Drug)
结局指标
主要结局
Metabolic control in patients treated with human insulin preparations insulin vs insulin analogues.
时间窗: 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)
次要结局
- 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)
