Improving Diabetes by Reconstruction Methods in Gastric Cancer Patients

Status Recruiting

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.

Clinical Trial 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 Design

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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01375738
Study type	Interventional
Source	Yonsei University
Contact
Status	Recruiting
Phase	N/A
Start date	July 2011
Completion date	May 2014

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms