Laparoscopic Gastric Bypass as Metabolic Surgery in Obesity Class 1

Study Overview
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Brief Summary
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Prospective study including Mexican patients diagnosed with type 2 diabetes and class 1 obesity, undergoing laparoscopic gastric bypass. The objective was to determine short, mid-and long-term outcomes (weight loss, metabolic, morbidity and diabetes remission). A subanalysis was included, based on preoperative usage of one (Group A) or more antidiabetics ± insulin (Group B).

Official Title
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Gastric Bypass as Metabolic Surgery in Obesity Class 1: a Prospective Study of the Short, Mid and Long Term Results Among Mexicans

Conditions
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Type2 Diabetes, Bariatric Surgery Candidate, Laparoscopic Gastric Bypass, Obesity

Intervention / Treatment
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* Procedure: Laparoscopic Gastric Bypass


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Any sex >18 years-old <60 years-old Class 1 obesity (BMI 30-34.9 kg/m2) Type-2 diabetes mellitus diagnosis (with or without medication) Submitted to laparoscopic gastric bypass Exclusion criteria Other bariatric surgery Revisional surgery Incomplete charts

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Laparoscopic Gastric Bypass|The LGBP was performed using a classic Roux-en-Y procedure. Briefly, a gastric pouch of 30-50 cc was constructed with an antecolic calibrated gastro-jejunal anastomosis (mechanical anastomosis using a 2.5 mm load). The biliary and alimentary limbs measured ≈70 cm and ≈150 cm, respectively, and the jejuno-jejunal anastomosis was also performed in a latero-lateral fashion (mechanical anastomosis using a 2.5 mm load). Mesenteric defects were closed with running non-absorbable sutures and the omentum was divided in every case|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Loss | Measure: weight (kilograms) | 12 months | 
| Weight Loss | Measure: weight (kilograms) | 24 months | 
| Weight Loss | Measure: weight (kilograms) | 36 months | 
| Weight Loss | Measure: Body Mass Index | 12 months | 
| Weight Loss | Measure: Body Mass Index | 24 months | 
| Weight Loss | Measure: Body Mass Index | 36 months | 
| Weight Loss | Measure: % excess weight loss | 12 months | 
| Weight Loss | Measure: % excess weight loss | 24 months | 
| Weight Loss | Measure: % excess weight loss | 36 months | 
| Weight Loss | Measure: % total weight loss | 12 months | 
| Weight Loss | Measure: % total weight loss | 24 months | 
| Weight Loss | Measure: % total weight loss | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete Diabetes Remission | Definition: no antidiabetic drugs while on glucose <100 mg/dl and HbA1C% <6 | 12 months | 
| Complete Diabetes Remission | Definition: no antidiabetic drugs while on glucose <100 mg/dl and HbA1C% <6 | 24 months | 
| Complete Diabetes Remission | Definition: no antidiabetic drugs while on glucose <100 mg/dl and HbA1C% <6 | 36 months | 
| Late complications | Complications requiring re-admssion / re-operation | After 30 days from surgery | 
| Early complications | Complications requiring re-admssion / re-operation | First 30 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bariatric surgery, obesity class 1, metabolic surgery, laparoscopic gastric bypass, type-2 diabetes mellitus