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临床试验/NCT03970668
NCT03970668已完成不适用

Linagliptin Plus Insulin for Hyperglycemia Immediately After Renal Transplantation: A Comparative Study

Universidad de Guanajuato0 个研究点目标入组 28 人开始时间: 2016年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
28
主要终点
Fasting glucose

研究概览

简要总结

Post-renal transplanted patients frequently present hyperglycemia immediately after the procedure.

This was a retrospective comparative study performed in post-renal transplanted patients in a single high speciality center with the goal of compare the effect of linagliptin + insulin in post-renal transplanted patients with hyperglycemia Interventions were linagliptin 5mg daily plus insulin vs insulin alone during 5 days after renal transplantation with hyperglycemia, and the main outcome were glucose levels, insulin dose and severity of hypoglycemia

详细描述

This was a retrospective comparative study performed in a single center between 2016 and 2018, included the data collected from 28 hospitalized post-renal transplanted patients that presented hyperglycemia (>140 mg/dl or or 7.77 mmol/l) immediately after renal transplantation (RT); 14 patients were treated with linagliptin 5mg daily plus a basal bolus insulin scheme prescribed by the Endocrinology group at the hospital, and 14 patients treated only with basal bolus insulin scheme were randomly selected from a list of patients treated during the same period of time and by the same Endocrinology group. Linagliptin dose was 5mg daily and the basal bolus insulin regimen was started and adjusted according to the international guidelines; in general, patients received a starting insulin dose of around 0.5 U/kg/day, given half as basal insulin (NPH or Glargine) once or twice daily and half as insulin lispro divided into three equal doses before meals. Insulin dose was adjusted daily to achieve the goal of fasting glucose between 80-140 mg/dl (4.44-7.77 mmol/l) or random glucose levels below 180 mg/dl (9.99 mmol/l). Correctional insulin dose was used before each meal, depending on the glucose measurements, starting at 1 unit for each 40mg above 140 mg/dl (7.77 mmol/l) of glucose. Glucose levels were monitored at fasting and before each meal, as well as at bedtime according to standard clinical practice. Data regarding fasting and preprandial glucose levels, hypoglycemia, renal function, and immunosuppression therapy were recorded from the patient´s file during the first 5 days after RT; fasting glucose and renal function were also recorded at 1, 6 and 12 months after RT. Patients were included if they were between 18-65 years of age and presented fasting hyperglycemia (>140 mg/dl or 7.77 mmol/l) immediately after RT.

Ethical and Research committee (CEI) at the Hospital approved the study protocol with the number CEI-49-18.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Hyperglycemia (glucose levels above 140 mg/dl) immediately after renal transplantation

排除标准

  • Incomplete records on the patients file
  • Acute complications such as liver failure

研究组 & 干预措施

Linagliptin plus insulin

Patients that presented hyperglycemia immediately after renal transplantation and received treatment with linagliptin plus insulin

干预措施: Linagliptin 5 mg Oral Tablet (Drug)

Insulin

Patients that presented hyperglycemia immediately after renal transplantation and received treatment only with insulin

干预措施: Insulin (Drug)

结局指标

主要结局

Fasting glucose

时间窗: 5 days

Fasting glucose levels at day 5

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rodolfo Guardado Mendoza

Principal Investigator

Universidad de Guanajuato

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