Improving Diabetes by Reconstruction Methods in Gastric Cancer Patients With Diabetes Mellitus
Conditions
Gastric Cancer - Diabetes
Conditions: official terms
Stomach Neoplasms
Conditions: Keywords
Early gastric cancer
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Roux-en Y gastrojejunostomy Type: Procedure
Name: Gastroduodenostomy Type: Procedure
Overall Status
Recruiting
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
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 20 Years
Gender: Both
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
Location
Severance Hospital
Seoul, Korea, Republic of
Status: Recruiting
Contact: Ji Yeong An, MD - 82-2-2228-2100 - jar319@yuhs.ac
Start Date
July 2011
Completion Date
May 2014
Sponsors
Yonsei University
Source
Yonsei University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page