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

20 Years
80 Years
Open (Enrolling)
Gastric Cancer, Diabetes

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Trial Information

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


- 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


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

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

- 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

- Measurement of GI hormones which have an effect on glucose tolerance

- Insulin, glucagon, IGF-1, GLP-1, Neuropeptide Y, Ghrelin, Leptin

- Correlation of reconstruction methods, parameters of diabetes and GI hormone

- Evaluation of mechanism of Roux-en-Y gastrojejunostomy on controlling diabetes

- Evaluation of Feasibility of Roux-en-Y gastrojejunostomy in gastric cancer surgery in
patients with DM

- Degree of high blood glucose control, the amount of antidiabetic medication, costs
for DM treatment, quality of life assessment

- Analysis for the mechanism of gastrointestinal physiology to diabetes control

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Blood sugar stabilization after gastrectomy

Outcome Description:

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

Outcome Time Frame:

three months after surgery

Safety Issue:



South Korea: Korea Food and Drug Administration (KFDA)

Study ID:




Start Date:

July 2011

Completion Date:

May 2014

Related Keywords:

  • Gastric Cancer
  • Diabetes
  • Early gastric cancer
  • Diabetes Mellitus
  • Stomach Neoplasms