Back to resultsSafety and Efficacy of Long Limb Roux-en Y Reconstruction (LoLiRoRe)
Primary Purpose
Diabetes Mellitus Type 2 in Nonobese, Gastric Cancer
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Long limb Roux-en Y reconstruction
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus Type 2 in Nonobese focused on measuring type II diabetes, Gastric cancer, Long limb Roux-en Y
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)
- 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
- 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
Sites / Locations
- GangNam Severance Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Long limb Roux-en Y reconstruction
Arm Description
Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy.
Outcomes
Primary Outcome Measures
Morbidity
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.
HbA1c
For the evaluation of efficacy for the operation, HbA1c(%) was measured serially (preop. 6months after op. until end of study(on average 14.8 months)).
HbA1c is formed in a non-enzymatic glycation pathway by hemoglobin's exposure to plasma glucose and measured by high-performance liquid chromatography (HPLC) The HbA1c was calculated as a ratio to total hemoglobin.
Hemoglobin
For the evaluation of long-term safety, hemoglobin was measured to determine the degree of anemia and malnutrition.
Albumin
For the evaluation of long-term safety, albumin was measured to determine malnutrition.
Operation Related Mortality
Operation related mortality was measured for the evaluation of safety for the operation. Operation related mortality was defined as any complication resulting in the death of the patient within 1 month or during hospitalization after operation.
Secondary Outcome Measures
Matsuda Index
Matsuda Index(Insulin Sensitivity Index) was measured.
The Matsuda index was obtained using the following formula:
Matsuda index = 10000/square root of [(fasting glucose × fasting insulin) × (mean glucose × mean insulin during OGTT)]
QUICKI
The quantitative insulin sensitivity check index (QUICKI) was measured.
The QUICKI was obtained using the following formula:
1 / (log(fasting insulin µU/mL) + log(fasting glucose mg/dL))
HOMA-IR
HOMA-IR(Homeostasis model assessment-estimated insulin resistance) was measured.
HOMA-IR was obtained using the following formula:
Glucose(mg/dl) x Insulin/405
HOMA-B
HOMA-B(Homoeostasis model assessment-derived beta-cell function) was measured.
HOMA-B was obtained using the following formula:
225 × 18/fasting insulin(mU/L) × fasting glucose(mg/dL)
Body Mass Index
BMI(Body Mass index , kg/㎡) was measured.
BMI was obtained using the following formula:
Weight (kg) / (Height (m) x Height (m))
Matsuda Index : Good Response Group
At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications after operation. We called this group as "good response group". We analyzed the change of insulin sensitivity after operation in good response group.
The Matsuda index(Insulin Sensitivity Index) was obtained using the following formula:
Matsuda index = 10000/square root of [(fasting glucose × fasting insulin) × (mean glucose × mean insulin during OGTT)]
QUICKI : Good Response Group
At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as "good response group". We analyzed the change of insulin sensitivity after operation in good response group. The quantitative insulin sensitivity check index (QUICKI) was measured.
The QUICKI is obtained using the following formula:
1 / (log(fasting insulin µU/mL) + log(fasting glucose mg/dL))
HOMA-IR : Good Response Group
At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as "good response group". We analyzed the change of insulin resistance after operation in good response group.
HOMA-IR(Homeostasis model assessment-estimated insulin resistance) was measured.
HOMA-IR was obtained using the following formula:
Glucose(mg/dl) x Insulin/405
HOMA-B : Good Response Group
At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as "good response group". We analyzed the change of beta-cell function after operation in good response group. HOMA-B(Homoeostasis model assessment-derived beta-cell function) was measured.
HOMA-B was obtained using the following formula:
225 × 18/fasting insulin(mU/L) × fasting glucose(mg/dL)
Body Mass Index : Good Response Group
At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as "good response group". We analyzed the change of weight change after operation in good response group.
BMI(Body Mass index , kg/㎡) was measured.
BMI was obtained using the following formula:
Weight (kg) / (Height (m) x Height (m))
HbA1c : Good Response Group
At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as "good response group". We analyzed the change of HbA1c after operation in good response group.
HbA1c is formed in a non-enzymatic glycation pathway by hemoglobin's exposure to plasma glucose and measured by high-performance liquid chromatography (HPLC)
The HbA1c was calculated as a ratio to total hemoglobin.
Hemoglobin : Good Response Group
At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as "good response group". For the evaluation of long-term safety, hemoglobin was measured to determine the degree of anemia and malnutrition in good response group.
Albumin : Good Response Group
At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as "good response group". We analyzed the change of albumin level after operation in good response group for the evaluation of long-term safety.
Full Information
NCT ID
NCT01373346
First Posted
June 13, 2011
Last Updated
August 30, 2012
Sponsor
Gangnam Severance Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01373346
Brief Title
Safety and Efficacy of Long Limb Roux-en Y Reconstruction
Acronym
LoLiRoRe
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
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gangnam Severance Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Type 2 in Nonobese, Gastric Cancer
Keywords
type II diabetes, Gastric cancer, Long limb Roux-en Y
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Long limb Roux-en Y reconstruction
Arm Type
Experimental
Arm Description
Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy.
Intervention Type
Procedure
Intervention Name(s)
Long limb Roux-en Y reconstruction
Other Intervention Name(s)
modified Roux-en Y
Intervention Description
After radical gastrectomy, the gastrointestinal tract was reconstructed by Roux-en-Y gastrojejunostomy or esophagojejunostomy. The jejunum was divided at approximately 100-120 cm distal to the ligament of Treitz and the distal limb of the jejunum was then anastomosed along the proximal gastric greater curvature or esophagus. The jejuno-jejunostomy was performed approximately 100 to 120 cm distal from the gastrojejunal or esophagojejunal anastomosis
Primary Outcome Measure Information:
Title
Morbidity
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.
Time Frame
Until end of study (on average 14.8 months)
Title
HbA1c
Description
For the evaluation of efficacy for the operation, HbA1c(%) was measured serially (preop. 6months after op. until end of study(on average 14.8 months)).
HbA1c is formed in a non-enzymatic glycation pathway by hemoglobin's exposure to plasma glucose and measured by high-performance liquid chromatography (HPLC) The HbA1c was calculated as a ratio to total hemoglobin.
Time Frame
Before operation , 6 months after operation, Until end of study (on average 14.8 months)
Title
Hemoglobin
Description
For the evaluation of long-term safety, hemoglobin was measured to determine the degree of anemia and malnutrition.
Time Frame
Before operation , 6 months after operation, Until end of study (on average 14.8 months)
Title
Albumin
Description
For the evaluation of long-term safety, albumin was measured to determine malnutrition.
Time Frame
Before operation , 6 months after operation, Until end of study (on average 14.8 months)
Title
Operation Related Mortality
Description
Operation related mortality was measured for the evaluation of safety for the operation. Operation related mortality was defined as any complication resulting in the death of the patient within 1 month or during hospitalization after operation.
Time Frame
Until end of study (on average 14.8 months)
Secondary Outcome Measure Information:
Title
Matsuda Index
Description
Matsuda Index(Insulin Sensitivity Index) was measured.
The Matsuda index was obtained using the following formula:
Matsuda index = 10000/square root of [(fasting glucose × fasting insulin) × (mean glucose × mean insulin during OGTT)]
Time Frame
Before operation , 6 months after operation, Until end of study (on average 14.8 months)
Title
QUICKI
Description
The quantitative insulin sensitivity check index (QUICKI) was measured.
The QUICKI was obtained using the following formula:
1 / (log(fasting insulin µU/mL) + log(fasting glucose mg/dL))
Time Frame
Before operation , 6 months after operation , Until end of study (on average 14.8 months)
Title
HOMA-IR
Description
HOMA-IR(Homeostasis model assessment-estimated insulin resistance) was measured.
HOMA-IR was obtained using the following formula:
Glucose(mg/dl) x Insulin/405
Time Frame
Before operation , 6 months after operation, Until end of study (on average 14.8 months)
Title
HOMA-B
Description
HOMA-B(Homoeostasis model assessment-derived beta-cell function) was measured.
HOMA-B was obtained using the following formula:
225 × 18/fasting insulin(mU/L) × fasting glucose(mg/dL)
Time Frame
Before operation , 6 months after operation, Until end of study (on average 14.8 months)
Title
Body Mass Index
Description
BMI(Body Mass index , kg/㎡) was measured.
BMI was obtained using the following formula:
Weight (kg) / (Height (m) x Height (m))
Time Frame
Before operation, 6 Months After Operation, Until End of Study(on Average 14.8 Months)
Title
Matsuda Index : Good Response Group
Description
At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications after operation. We called this group as "good response group". We analyzed the change of insulin sensitivity after operation in good response group.
The Matsuda index(Insulin Sensitivity Index) was obtained using the following formula:
Matsuda index = 10000/square root of [(fasting glucose × fasting insulin) × (mean glucose × mean insulin during OGTT)]
Time Frame
Before operation , 6 months after operation, Until end of study (on average 14.8 months)
Title
QUICKI : Good Response Group
Description
At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as "good response group". We analyzed the change of insulin sensitivity after operation in good response group. The quantitative insulin sensitivity check index (QUICKI) was measured.
The QUICKI is obtained using the following formula:
1 / (log(fasting insulin µU/mL) + log(fasting glucose mg/dL))
Time Frame
Before operation, 6 months after operation, Until end of study (on average 14.8 months)
Title
HOMA-IR : Good Response Group
Description
At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as "good response group". We analyzed the change of insulin resistance after operation in good response group.
HOMA-IR(Homeostasis model assessment-estimated insulin resistance) was measured.
HOMA-IR was obtained using the following formula:
Glucose(mg/dl) x Insulin/405
Time Frame
Before operation, 6 months after operation, Until end of study (on average 14.8 months)
Title
HOMA-B : Good Response Group
Description
At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as "good response group". We analyzed the change of beta-cell function after operation in good response group. HOMA-B(Homoeostasis model assessment-derived beta-cell function) was measured.
HOMA-B was obtained using the following formula:
225 × 18/fasting insulin(mU/L) × fasting glucose(mg/dL)
Time Frame
Before operation, 6 months after operation, Until end of study (on average 14.8 months)
Title
Body Mass Index : Good Response Group
Description
At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as "good response group". We analyzed the change of weight change after operation in good response group.
BMI(Body Mass index , kg/㎡) was measured.
BMI was obtained using the following formula:
Weight (kg) / (Height (m) x Height (m))
Time Frame
Before operation, 6 months after operation, Until end of study (on average 14.8 months)
Title
HbA1c : Good Response Group
Description
At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as "good response group". We analyzed the change of HbA1c after operation in good response group.
HbA1c is formed in a non-enzymatic glycation pathway by hemoglobin's exposure to plasma glucose and measured by high-performance liquid chromatography (HPLC)
The HbA1c was calculated as a ratio to total hemoglobin.
Time Frame
Before operation, 6 months after operation, Until end of study (on average 14.8 months)
Title
Hemoglobin : Good Response Group
Description
At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as "good response group". For the evaluation of long-term safety, hemoglobin was measured to determine the degree of anemia and malnutrition in good response group.
Time Frame
Before operation, 6 months after operation, Until end of study (on average 14.8 months)
Title
Albumin : Good Response Group
Description
At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as "good response group". We analyzed the change of albumin level after operation in good response group for the evaluation of long-term safety.
Time Frame
Before operation, 6 months after operation, Until end of study (on average 14.8 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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)
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seung Ho Choi, M.D., Ph.D.
Organizational Affiliation
Department of Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
GangNam Severance Hospital
City
Seoul
ZIP/Postal Code
146-92
Country
Korea, Republic of
12. IPD Sharing Statement
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19272486
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Safety and Efficacy of Long Limb Roux-en Y Reconstruction
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