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

September 12, 2012 updated by: ji yeong an, Yonsei University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Gastroduodenostomy
Arm 1: undergo gastroduodenostomy after distal gastrectomy for gastric cancer
Procedure: Gastroduodenostomy
After subtotal gastrectomy with lymph node dissection, the gastric remnant is anastomosed to duodenum 1st portion with circular or linear staplers and the artificial lesser curvature is repaired with linear stapler.
Experimental: Roux-en Y gastrojejunostomy
Arm 2: undergo Roux-en Y gastrojejunostomy after distal gastrectomy for gastric cancer
Procedure: Roux-en Y gastrojejunostomy
After subtotal gastrectomy with lymph node dissection, the jejunum is transected 25~30cm distal to the ligament of Treitz. Distal jejunum is drawn up and sutured to the gastric remnant and the proximal jejunum is anastomosed to the distal jejunum at 30~40cm from the new gastric-jejunal junction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood sugar stabilization after gastrectomy
Time Frame: three months after surgery
By comparing the difference between fasting blood sugar and postprandial blood glucose, blood sugar stabilization after gastrectomy will be maesured.
three months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Anticipated)

June 1, 2013

Study Completion (Anticipated)

May 1, 2014

Study Registration Dates

First Submitted

May 27, 2011

First Submitted That Met QC Criteria

June 15, 2011

First Posted (Estimate)

June 17, 2011

Study Record Updates

Last Update Posted (Estimate)

September 13, 2012

Last Update Submitted That Met QC Criteria

September 12, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2011-0109

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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