Clinical trial NCT01373346: Safety and Efficacy of Long Limb Roux-en Y Reconstruction
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus Type 2 in Nonobese
Gastric Cancer
Keywords: type II diabetes
Gastric cancer
Long limb Roux-en Y
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2011-06-14
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: We grafted the concept of metabolic surgery (long limb Roux-en Y reconstruction) into gastric cancer surgery. This study aimed to investigate the safety and efficacy of long limb Roux-en Y reconstruction after gastrectomy in non-obese type II diabetes with gastric cancer.

Detailed description: 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.

Eligibility criteria: 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 200mg/dl
  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

Primary outcomes:
measure: Morbidity
timeFrame: Until end of study (on average 14.8 months)
measure: HbA1c
timeFrame: Before operation , 6 months after operation, Until end of study (on average 14.8 months)
measure: Hemoglobin
timeFrame: Before operation , 6 months after operation, Until end of study (on average 14.8 months)
measure: Albumin
timeFrame: Before operation , 6 months after operation, Until end of study (on average 14.8 months)
measure: Operation Related Mortality
timeFrame: Until end of study (on average 14.8 months)
Secondary outcomes:
measure: Matsuda Index
timeFrame: Before operation , 6 months after operation, Until end of study (on average 14.8 months)
measure: QUICKI
timeFrame: Before operation , 6 months after operation , Until end of study (on average 14.8 months)
measure: HOMA-IR
timeFrame: Before operation , 6 months after operation, Until end of study (on average 14.8 months)
measure: HOMA-B
timeFrame: Before operation , 6 months after operation, Until end of study (on average 14.8 months)
measure: Body Mass Index
timeFrame: Before operation, 6 Months After Operation, Until End of Study(on Average 14.8 Months)
measure: Matsuda Index : Good Response Group
timeFrame: Before operation , 6 months after operation, Until end of study (on average 14.8 months)
measure: QUICKI : Good Response Group
timeFrame: Before operation, 6 months after operation, Until end of study (on average 14.8 months)
measure: HOMA-IR : Good Response Group
timeFrame: Before operation, 6 months after operation, Until end of study (on average 14.8 months)
measure: HOMA-B : Good Response Group
timeFrame: Before operation, 6 months after operation, Until end of study (on average 14.8 months)
measure: Body Mass Index : Good Response Group
timeFrame: Before operation, 6 months after operation, Until end of study (on average 14.8 months)
measure: HbA1c : Good Response Group
timeFrame: Before operation, 6 months after operation, Until end of study (on average 14.8 months)
measure: Hemoglobin : Good Response Group
timeFrame: Before operation, 6 months after operation, Until end of study (on average 14.8 months)
measure: Albumin : Good Response Group
timeFrame: Before operation, 6 months after operation, Until end of study (on average 14.8 months)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: GangNam Severance Hospital
Study officials:
affiliation: Department of Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea
name: Seung Ho Choi, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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