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临床试验/NCT01375738
NCT01375738Unknown不适用

The Effect and Mechanism of Improving Diabetes by Reconstruction Methods in Gastric Cancer Patients With DM Who Receive Surgical Treatment

Yonsei University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2011年7月最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
2
主要终点
Blood sugar stabilization after gastrectomy

研究概览

简要总结

This study is to investigate the effect of gastrectomy on remission of type 2 diabetes in patients with gastric cancer and type 2 diabetes, to investigate the mechanism of blood glucose alteration and intestinal hormonal signaling by the reconstruction methods, and to evaluate the applicability and efficacy of Roux-en-Y gastrojejunostomy after gastrectomy in gastric cancer patients with diabetes.

详细描述

Purpose:

  • To investigate the effect of gastrectomy on remission of type 2 diabetes in patients with gastric cancer and type 2 diabetes
  • To investigate the mechanism of blood glucose alteration and intestinal hormonal signaling by the reconstruction methods
  • To evaluate the applicability and efficacy of Roux-en-Y gastrojejunostomy after gastrectomy in gastric cancer patients with diabetes

Contents:

  • Evaluation of the status of diabetes in gastric cancer patients with DM after gastrectomy

  • Comparison of two reconstruction types after gastrectomy Bypass duodenum and upper jejunum: Roux-en-Y gastrojejunostomy Preservation of duodenal passage: Gastroduodenostomy

  • Analysis for biochemical markers reflecting diabetic status: fasting glucose, postprandial 2h glucose, HbA1c, C-peptide, lipid profile

  • Correlation of parameters associated with diabetes and GI hormones

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
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient who are older than 20 years and younger than 80 years
  • Histologically confirmed gastric adenocarcinoma located lower one third of stomach
  • Postoperative confirmed pT1N0, pT2N0, pT1N1
  • Informed consent

排除标准

  • Previous history of treatment for other malignancy or inflammatory disease
  • Preoperative uncontrolled serious comorbidity
  • Vulnerable Subjects(pregnant women, children, cognitively impaired persons etc.)
  • Patient who experience any complications requiring reoperation following gastrectomy

结局指标

主要结局

Blood sugar stabilization after gastrectomy

时间窗: three months after surgery

By comparing the difference between fasting blood sugar and postprandial blood glucose, blood sugar stabilization after gastrectomy will be maesured.

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

ji yeong an

assistant professor

Yonsei University

研究点 (2)

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