Clinical trial NCT01375738: Improving Diabetes by Reconstruction Methods in Gastric Cancer Patients With Diabetes Mellitus
Official title: The Effect and Mechanism of Improving Diabetes by Reconstruction Methods in Gastric Cancer Patients With DM Who Receive Surgical Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastric Cancer
Diabetes
Keywords: Early gastric cancer
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2011-06-17
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Eligibility 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

Primary outcomes:
measure: Blood sugar stabilization after gastrectomy
timeFrame: three months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
citation: 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.
citation: Nishizaki D, Ganeko R, Hoshino N, Hida K, Obama K, Furukawa TA, Sakai Y, Watanabe N. Roux-en-Y versus Billroth-I reconstruction after distal gastrectomy for gastric cancer. Cochrane Database Syst Rev. 2021 Sep 15;9(9):CD012998. doi: 10.1002/14651858.CD012998.pub2.