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

Yonsei University

Status: Unknown

Conditions: Diabetes; Gastric Cancer

Treatments: Procedure: Roux-en Y gastrojejunostomy; Procedure: Gastroduodenostomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01375738

4-2011-0109

Details and patient eligibility

About

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.

Full 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

Enrollment: 40 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Gastroduodenostomy

Active Comparator group

Description:

Arm 1: undergo gastroduodenostomy after distal gastrectomy for gastric cancer

Treatment:

Procedure: Gastroduodenostomy

Roux-en Y gastrojejunostomy

Experimental group

Description:

Arm 2: undergo Roux-en Y gastrojejunostomy after distal gastrectomy for gastric cancer

Treatment:

Procedure: Roux-en Y gastrojejunostomy