N/A
N=15
Safety and Efficacy of Long Limb Roux-en Y Reconstruction
Diabetes Mellitus Type 2 in Nonobese · Gastric Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01373346 ↗Enrolled (actual)
15
Serious AEs
13.3%
Results posted
Aug 2012
Primary outcome: Primary: Morbidity — 4 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Long limb Roux-en Y reconstruction (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Gangnam Severance Hospital
- Primary completion
- Jan 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Morbidity |
4 | — |
| PRIMARY HbA1c |
7.7; 6.3; 6.3 | — |
| PRIMARY Hemoglobin |
13.0; 12.5; 12.5 | — |
| PRIMARY Albumin |
4.4; 4.3; 3.9 | — |
| PRIMARY Operation Related Mortality |
— | — |
| SECONDARY Matsuda Index |
7.2; 15.4; 17.1 | — |
| SECONDARY QUICKI |
0.4; 0.4; 0.4 | — |
| SECONDARY HOMA-IR |
2.2; 1.0; 1.0 | — |
| SECONDARY HOMA-B |
7.7; 13.4; 16.0 | — |
| SECONDARY Body Mass Index |
25.2; 21.7; 21.2 | — |
| SECONDARY Matsuda Index : Good Response Group |
5.7; 14.6; 12.7 | — |
| SECONDARY QUICKI : Good Response Group |
0.4; 0.4; 0.5 | — |
| SECONDARY HOMA-IR : Good Response Group |
1.9; 0.9; 0.8 | — |
| SECONDARY HOMA-B : Good Response Group |
8.7; 13.4; 17.8 | — |
| SECONDARY Body Mass Index : Good Response Group |
25.7; 22.0; 21.5 | — |
| SECONDARY HbA1c : Good Response Group |
7.2; 6.0; 6.0 | — |
| SECONDARY Hemoglobin : Good Response Group |
13.0; 12.5; 12.5 | — |
| SECONDARY Albumin : Good Response Group |
4.4; 4.2; 3.9 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01373346). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.