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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01375738
• Other study ID #: 4-2011-0109
• Status: Recruiting
• Phase: N/A
• First received: May 27, 2011
• Last updated: September 12, 2012
• Start date: July 2011
• Est. completion date: May 2014

Study information

• Verified date: September 2012
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 2014
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Diabetes
• Gastric Cancer
• Stomach Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Yang J, Li C, Liu H, Gu H, Chen P, Liu B. Effects of subtotal gastrectomy and Roux-en-Y gastrojejunostomy on the clinical outcome of type 2 diabetes mellitus. J Surg Res. 2010 Nov;164(1):e67-71. doi: 10.1016/j.jss.2010.07.004. Epub 2010 Jul 30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood sugar stabilization after gastrectomy	By comparing the difference between fasting blood sugar and postprandial blood glucose, blood sugar stabilization after gastrectomy will be maesured.	three months after surgery	No