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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Yonsei University
Sponsor:
Information provided by (Responsible Party):
ji yeong an, Yonsei University
ClinicalTrials.gov Identifier:
NCT01375738
First received: May 27, 2011
Last updated: September 12, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
Gastric Cancer
Diabetes
Procedure: Roux-en Y gastrojejunostomy
Procedure: Gastroduodenostomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect and Mechanism of Improving Diabetes by Reconstruction Methods in Gastric Cancer Patients With DM Who Receive Surgical Treatment

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Blood sugar stabilization after gastrectomy [ Time Frame: three months after surgery ] [ Designated as safety issue: No ]
    By comparing the difference between fasting blood sugar and postprandial blood glucose, blood sugar stabilization after gastrectomy will be maesured.


Estimated Enrollment: 40
Study Start Date: July 2011
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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
  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01375738

Locations
Korea, Republic of
Severance Hospital Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Ji Yeong An, MD    82-2-2228-2100    jar319@yuhs.ac   
Contact: Yoo-Min Kim, MD       AUG79@yuhs.ac   
Sponsors and Collaborators
Yonsei University
  More Information

Publications:
Responsible Party: ji yeong an, assistant professor, Yonsei University
ClinicalTrials.gov Identifier: NCT01375738     History of Changes
Other Study ID Numbers: 4-2011-0109
Study First Received: May 27, 2011
Last Updated: September 12, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Yonsei University:
Early gastric cancer

Additional relevant MeSH terms:
Diabetes Mellitus
Stomach Neoplasms
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on July 26, 2014