Improving Diabetes by Reconstruction Methods in Gastric Cancer Patients With Diabetes Mellitus

Not Applicable

• Conditions: Gastric Cancer; Diabetes
• Interventions: Procedure: Gastroduodenostomy; Procedure: Roux-en Y gastrojejunostomy

• Registration Number: NCT01375738
• Lead Sponsor: Yonsei University

Brief Summary

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.

Detailed Description

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

* 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 levels

* 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

Study Timeline

• Study First Submitted: 2011-05-27
• Study First Submitted QC: 2011-06-15
• Study First Posted: 2011-06-17
• Study Start: 2011-07
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-12
• Last Update Posted: 2012-09-13
• Primary Completion: 2013-06
• Study Completion: 2014-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gastroduodenostomy	Gastroduodenostomy	Arm 1: undergo gastroduodenostomy after distal gastrectomy for gastric cancer
Roux-en Y gastrojejunostomy	Roux-en Y gastrojejunostomy	Arm 2: undergo Roux-en Y gastrojejunostomy after distal gastrectomy for gastric cancer

Primary Outcome Measures

Name	Time	Method
Blood sugar stabilization after gastrectomy	three months after surgery	By comparing the difference between fasting blood sugar and postprandial blood glucose, blood sugar stabilization after gastrectomy will be maesured.

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of