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临床试验/NCT01435707
NCT01435707已完成不适用

The Effect of Epidural Steroid Injections on Glycemic Control in Diabetic Patients According to the Doses of Steroids

Samsung Medical Center2 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2011年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
125
试验地点
2
主要终点
fasting blood glucose level

研究概览

简要总结

There has been no reports of the effect of various kinds of steroid or various dose of steroid which are commonly used in the clinical setting. Previous studies have simply shown that the blood glucose level is elevated in diabetes patients and did not show or suggest the adequate strategy of epidural steroid injection in diabetes patients regarding steroid type, dosage or injection interval. Therefore, the investigators tried to evaluate the effect of different dosage of triamcinolone, which is a commonly used steroid in epidural steroid injection, on the blood glucose level.

详细描述

It is well known that blood glucose level is elevated in diabetes patients more than non-diabetes patients who underwent the epidural steroid injection. However, there has been no reports of the effect of various kinds of steroid or various dose of steroid which are commonly used in the clinical setting. Previous studies have simply shown that the blood glucose level is elevated in diabetes patients and did not show or suggest the adequate strategy of epidural steroid injection in diabetes patients regarding steroid type, dosage or injection interval. Therefore, the investigators tried to evaluate the effect of different dosage of triamcinolone, which is a commonly used steroid in epidural steroid injection, on the blood glucose level.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
盲法
Single (Participant)

入排标准

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

入选标准

  • subjects who undergo epidural steroid injection (caudal epidural injection or selective transforaminal block) in the pain medicine outpatient clinic
  • subjects older than 20 yrs.

排除标准

  • ASA (American society of Anesthesiologists class) III or more
  • severe cardiopulmonary disease or brain disorder
  • Subjects diagnosed uncontrolled diabetes with complications
  • subjects undergoing hormone therapy
  • subjects with active infection
  • subjects with pregnancy
  • subjects with recent stress condition such as surgery or trauma
  • subjects with active neurologic disorder
  • those with anticoagulation therapy

结局指标

主要结局

fasting blood glucose level

时间窗: at 7:00 am of postprocedure day 7

fasting blood glucose

时间窗: at 7:00 am of postprocedure day 14

次要结局

  • post-prandial glucose level(2 hour after dinner at postprandial day 1, 2, 3, 4, 5, 6, 7, 14)
  • visual analogue scale of subjective pain(at 7 p.m. of postprocedure day 1, 2, 3, 4, 5, 6, 7, 14)

研究者

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

Woo Seog Sim

Associate Professor

Samsung Medical Center

研究点 (2)

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