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NCT Number: NCT01373346

Safety and Efficacy of Long Limb Roux-en Y Reconstruction

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.

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Key information

Conditions

Diabetes Mellitus Type 2 in Nonobese Diabetes Mellitus Diabetes Mellitus, Type 2 Digestive System Diseases Digestive System Neoplasms Endocrine System Diseases Gastric Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Glucose Metabolism Disorders Metabolic Diseases Neoplasms Neoplasms by Site Nutritional and Metabolic Diseases Stomach Diseases Stomach Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GangNam Severance Hospital

Seoul, 146-92, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Long limb Roux-en Y reconstruction

Procedure

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

Other names: modified Roux-en Y

Primary outcomes

  1. Morbidity

    Time frame: Until end of study (on average 14.8 months)

    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.

  2. HbA1c

    Time frame: Before operation , 6 months after operation, Until end of study (on average 14.8 months)

    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.

  3. Hemoglobin

    Time frame: Before operation , 6 months after operation, Until end of study (on average 14.8 months)

    For the evaluation of long-term safety, hemoglobin was measured to determine the degree of anemia and malnutrition.

  4. Albumin

    Time frame: Before operation , 6 months after operation, Until end of study (on average 14.8 months)

    For the evaluation of long-term safety, albumin was measured to determine malnutrition.

  5. Operation Related Mortality

    Time frame: Until end of study (on average 14.8 months)

    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 outcomes

  1. Matsuda Index

    Time frame: Before operation , 6 months after operation, Until end of study (on average 14.8 months)

    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)]

  2. QUICKI

    Time frame: Before operation , 6 months after operation , Until end of study (on average 14.8 months)

    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))

  3. HOMA-IR

    Time frame: Before operation , 6 months after operation, Until end of study (on average 14.8 months)

    HOMA-IR(Homeostasis model assessment-estimated insulin resistance) was measured.

    HOMA-IR was obtained using the following formula:

    Glucose(mg/dl) x Insulin/405

  4. HOMA-B

    Time frame: Before operation , 6 months after operation, Until end of study (on average 14.8 months)

    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)

  5. Body Mass Index

    Time frame: Before operation, 6 Months After Operation, Until End of Study(on Average 14.8 Months)

    BMI(Body Mass index , kg/㎡) was measured.

    BMI was obtained using the following formula:

    Weight (kg) / (Height (m) x Height (m))

  6. Matsuda Index : Good Response Group

    Time frame: Before operation , 6 months after operation, Until end of study (on average 14.8 months)

    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)]

  7. QUICKI : Good Response Group

    Time frame: Before operation, 6 months after operation, Until end of study (on average 14.8 months)

    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))

  8. HOMA-IR : Good Response Group

    Time frame: Before operation, 6 months after operation, Until end of study (on average 14.8 months)

    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

  9. HOMA-B : Good Response Group

    Time frame: Before operation, 6 months after operation, Until end of study (on average 14.8 months)

    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)

  10. Body Mass Index : Good Response Group

    Time frame: Before operation, 6 months after operation, Until end of study (on average 14.8 months)

    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))

  11. HbA1c : Good Response Group

    Time frame: Before operation, 6 months after operation, Until end of study (on average 14.8 months)

    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.

  12. Hemoglobin : Good Response Group

    Time frame: Before operation, 6 months after operation, Until end of study (on average 14.8 months)

    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.

  13. Albumin : Good Response Group

    Time frame: Before operation, 6 months after operation, Until end of study (on average 14.8 months)

    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.

Sponsors and collaborators

Lead sponsor

Gangnam Severance Hospital

Other

Registry information

Official study 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

Acronym: LoLiRoRe

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jun 14, 2011
Registry last updated
Sep 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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