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Long Limb Roux-en Y Reconstruction After Gastrectomy As A Potential Cure for Type 2 Diabetes Mellitus in Non-Obese Gastric Cancer Patients - a Pilot Project to Validate a Prospective Randomized Control Trial

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75 Years
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Diabetes Mellitus Type 2 in Nonobese, Gastric Cancer

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Trial Information

Long Limb Roux-en Y Reconstruction After Gastrectomy As A Potential Cure for Type 2 Diabetes Mellitus in Non-Obese Gastric Cancer Patients - a Pilot Project to Validate a Prospective Randomized Control Trial

Type II diabetes in the world is increasing rapidly, and it is known that patients with type
II diabetes with morbid obesity that underwent bariatric surgery have resolution of impaired
glucose metabolism.

In Asia, most type II diabetes are not morbidly obese and still, it is controversy whether
metabolic surgery is effective or not in non-morbid obese patients. As life expectancy is
increased, the number of patients with gastric cancer and T2DM is increased as well.

Recently, we studied the outcome of T2DM after gastrectomy and conventional reconstruction
in non-obese gastric cancer patients.(Kim JW et al, World J Gastroenterol 2012;18:49) The
study was a large-series retrospective study including about 400 patients and the result
regarding DM improvement was not satisfactory. Based on our previous results, it is needed
to find more effective way to resolve the type II diabetes in gastrectomized patients with
gastric cancer.

Inclusion Criteria:

- Pathologically confirmed gastric cancer with potentially curable state

- Non-obese (Body mass index: less than 30 kg/m2)

- Have a history of Type 2 DM over 6 months (diagnosed by ADA criteria)

1. HBA1c: more than 6.5 %, or Fasting glucose: more than 126 mg/dl (7.0mmol/L) or
2-h plasma glucose: more than 200mg/dl during an OGTT or classic symptoms of
hyperglycemia or hyperglycemic crisis, a random plasma glucose: more than

2. Anti-GAD antibody (-), Anti-islet antibody (-)

- C-peptide level: above 1ng/ml

Exclusion Criteria:

- Patient who receive non-curative operation

- Patient who have less than one year life expectancy

- Pregnant patient

- Acute inflammation status patient

- Chronic renal disease patient (Serum creatin level: more than 1.5mg/dl)

- Chronic liver disease patient (Serum AST or ALT level: more than twice of upper
limit of normal range)

- Have a history of receiving medications such as dipeptidyl peptidase IV(DPP- IV)
inhibitor or glucagon like peptide-I (GLP-I) analogue

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Description:

For the evaluation of safety, morbidity were analyzed. For the evaluation of short-term safety, complications higher than the Clavien-Dindo grade II (Dindo et. Ann Surg 240:205 2004) were collected. *Clavien-dindo classification of surgical complications Grade II: Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included. Grade III: Requiring surgical, endoscopic or radiological intervention Grade IV:Life-threatening complication (including CNS complications)‡ requiring IC/ICU-management Grade V:Death of a patient Suffix'd' : If the patient suffers from a complication at the time of discharge ,the suffix "d" (for 'disability') is added to the respective grade of complication. This label indicates the need for a follow-up to fully evaluate the complication. For the evaluation of long-term safety, the patients were evaluated every month after discharge.

Outcome Time Frame:

Until end of study (on average 14.8 months)

Safety Issue:


Principal Investigator

Seung Ho Choi, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea


Korea: Institutional Review Board

Study ID:




Start Date:

February 2010

Completion Date:

January 2012

Related Keywords:

  • Diabetes Mellitus Type 2 in Nonobese
  • Gastric Cancer
  • type II diabetes
  • Gastric cancer
  • Long limb Roux-en Y
  • Diabetes Mellitus
  • Diabetes Mellitus, Type 2
  • Stomach Neoplasms