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临床试验/NCT00776243
NCT00776243已完成不适用

Short-term Effect of Intensive Insulin Therapy on Incretin Secretion

The Catholic University of Korea2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2008年10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
30
试验地点
2
主要终点
Difference of incretin secretion before and after intensive insulin therapy

研究概览

简要总结

In type 2 diabetic patients, abnormality in secretion or action of incretin(GLP-1, GIP) is observed. Although controversy still exists, the secretion of GLP-1 is thought to be reduced by 20-30% while GIP secretion is normal or slightly elevated, in type 2 diabetic patients. Various parameters such as the duration of diabetes, the amount of meal and their constitution, gastric bypass surgery, and some antidiabetic drugs affect the secretion of incretin. However, the secretion of GLP-1 and GIP in glucotoxic condition and whether they recover after improvement of glycemic status is not known. The investigators aim to study the effect of intensive insulin treatment in uncontrolled diabetic patients.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • type 2 diabetic patients with disease duration of less than 15years
  • age of 20-70 years
  • BMI 22-27
  • HbA1c 9-13%
  • patients willing to receive intensive glucose control
  • patients who are able to monitor their glucose level at home
  • for normal glucose tolerance group : NGT subjects with same range of age and BMI
  • for early diabetes group : patients with diabetic duration of less than 5 years and HbA1c level less than 7.5% for at least last 6 months

排除标准

  • previous history of insulin treatment
  • patients taking alpha-glucosidase inhibitor or thiazolidinedione
  • serum creatinine >= 1.5 mg/dL
  • hemoglobin < 10 g/dL
  • AST/ALT greater than 3 times normal range
  • ischemic heart disease, congestive heart failure (NYHA grade >=2)
  • chronic renal failure, proliferative diabetic retinopathy, CVA
  • patients with gastroparesis or taking medications altering gastric motility
  • usage of steroid or other agents affecting glucose metabolism
  • pregnant or breast-feeding women

结局指标

主要结局

Difference of incretin secretion before and after intensive insulin therapy

时间窗: 2 months

次要结局

  • Factors affecting incretin secretion(basal)
  • Difference in incretin secretion according to the duration of diabetes(basal)

研究者

申办方类型
Other

研究点 (2)

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